Archive for May, 2020
Mum’s brutal stem cell treatment has ‘all been worth it’ as she enjoys time with family – Grimsby Live
A Scunthorpe mum who underwent 'brutal' stem cell treatment says the hardest part was not being able to see her daughters.
Joanne While has recently passed the six month anniversary of the treatment to wipe out and then regrow her immune system.
The mum-of-three was diagnosed with Multiple Sclerosis (MS) at the age of 31, and wasn't eligible for trial treatments in the UK.
The HSCTtreatment in Mexico saw her undergo chemotherapy and then have stem cells transplanted in the hopes of stopping the damage that the MS was causing. Some MS patients have also seen their symptoms be reversed from this.
"It was a very harsh, brutal treatment. I had to be kept in a special apartment where I protected from all germs. There was a lot of sickness and just getting out of bed some days was difficult," Joanne said.
"The hardest part was being away from my family. My ex-partner was very kind in taking a months unpaid leave to come to Mexico and help me through the treatment.
"At the end of the day, all of the treatment has been worth it.
"I had a brain MRI scan two months ago which showed that the MS lesions hadnt grown since last time. My body is still recovering, so time will tell exactly how good the news is."
The HSCT (haematopoietic stem cell transplantation) treatment cost the family 45,000 including flights and visas. They launched an online fundraising page last year to help cover the costs.
With her weak immune system still being rebuilt, Joanne has been shielding since before the coronavirus outbreak began.
Her family have adopted extremely strict hygiene measures at the Scunthorpe home to keep her healthy during this critical time.
HSCT is a chemotherapy-based medical procedure that wipes out the immune system and reboots it using a patient's own stem cells, which are harvested from their blood or bone marrow,
The aim is to reset the immune system to stop it attacking the rest of the body, therefore halting the progression of the MS.
It is the only medical procedure currently available that has halted the progression of the majority of patients undertaking it.
HSCT is currently available only on a trial basis in the UK, and only for individuals who have been unsuccessful with the range ofdisease modifying therapies. Each time it fails, irreparable damage is being done and the disease continues to progress.
"Before the outbreak, it had just gotten to the point where I was able to venture out for a coffee, but of course all of that has stopped now," Joanne said.
"I had to pull my daughters out of school early to minimise the risk of them bringing the virus home. Now we regularly sanitise the house and change clothes whenever we have to enter or leave in order to keep it as clean as possible.
"My eldest daughter, who is 24, has been wonderful as my carer. She has stopped work to prevent her from catching any infections.
"Im often tired and need a three hour nap in the afternoon, which can be difficult with a five-year-old in the house. Its been a balancing act, but Im so grateful to everyone who helped me during or since the treatment.
"Shielding can be frustrating, but its all about your mindset when you look at it. Its not that I cant go outside I get to be at home in my favourite place with my daughters."
Due to her compromised immune system, Joanne has had to start her vaccinations again and has just been given those that are usually given to babies.
Tests have also shown that her white blood count has recently decreased to the point it was in Mexico, although Joanne has hopeful it will recover.
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HSCT can initially cause mobility issues and stiffness in muscles, which Joanne is having physio to manage.
She is documenting her recovery on her Facebook page 'Jo's HSCT Journey'.
Growing Number of Patients Suffering From Neurological Disorder to Support the Growth of Global Autologous Cell Therapy Market, TMR – PRNewswire
ALBANY, New York, May 11, 2020 /PRNewswire/ -- As a result of growing pandemic of COVID-19, the pharmaceutical industry is investing a major amount in research and development of an effective vaccine that can help the doctors to save lives and help controlling the pandemic. As per a recent analysis by Transparency Market Research over pharmaceutical sector, it was found that the global autologous cell therapy market is witnessing a major push. The market is projected to grow exponentially during the tenure of 2019 to 2027 and is expected to witness a substantial 18.1% CAGR during this tenure. Moreover, the global autologous cell therapy market is expected to register a value of US$ 34.7 Bn by the end of 2027, says a recent report by Transparency Market Research.
"COVID-19 has impacted the economy at global level. With the death tolls still on the rise in developed and developing countries, the pandemic nowhere seems to get stop. However, the pharmaceutical sector is constantly investing in research and development. Nevertheless, the industry is majorly investing in autologous cell therapyto find an effective cure for CORONA Virus. Owing to these research and development, the global autologous cell therapy market is projected to grow exponentially during the tenure of 2019 to 2027" Transparency Market Research.
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Major Finding in Global Autologous Cell Therapy Market Study
Explore the latest study on global autologous cell therapy market under the title: Autologous Cell Therapy Market (Source - Bone Marrow and Epidermis; Application - Neurology, Orthopedics, Cancer, Wound Healing, CVD, and Autoimmune; End User - Hospitals, Ambulatory Centers, and Research Centers) - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast 2019 2027 at https://www.transparencymarketresearch.com/report-toc/715
Major Drivers Propelling the Growth of Global Autologous Cell Therapy Market
Growing cases of Neurological Disorders to Propel the Growth
The world is witnessing a massive growth in the number of patients suffering from neurological diseases. The report by Transparency Market Research states that there are more than 50 Mn people suffering from autoimmune disorder which can cause a painful death. In order to develop an effective drug that can help the neurological patients, the pharmaceutical industry is investing massive in autologous cell therapywhich as a result is propelling the growth of global autologous cell therapy market during the tenure of 2019 to 2027.
Strong Government Support to Boost the Growth of the Autologous Cell Therapy Market
Governments across the globe are encouraging pharmaceutical industry to develop an effective cure for Parkinson's, nervous breakdowns, and most importantly COVID-19. This has significantly helped the players to develop new drugs. Owing to this support, the global autologous cell therapy market shall witness a substantial growth during the tenure of 2019 to 2027, states the report by Transparency Market Research.
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Major Challenges Mentioned in the Global Autologous Cell Therapy Market
The major challenge that might impede the growth of global autologous cell therapy market is the cost of the therapy. Since the cost of therapy is quite high, the some of the patient might not be able to afford it which might deplete the growth of global autologous cell therapy market during the tenure of 2019 to 2029. However, with ongoing research and development in the pharmaceutical industry, there are high chances that the world might see a cost effective therapy in the global autologous cell therapy market in future.
Global Autologous Cell Therapy: Regional Analysis
North America shall account for the largest share in the global autologous cell therapy market in future. It is noticeable that the regional front of the global autologous cell therapy market was dominated by this particular region in 2018. This dominance is the result of improving healthcare infrastructure, technological development and supportive government efforts. Owing to these factors the global autologous cell therapy market is expected to be dominated by North America during the tenure of 2019 to 2027.
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Competitive Analysis
The global autologous cell therapy market is highly progressive yet highly consolidated. The nature of the market is the result of presence of AA handful of prominent players. However, due to this the new players are unable to enter the global autologous cell therapy market. To overcome this situation, the new players are merging and collaborating with the established players of global disposable face mask market.
The global autologous cell therapy market is segmented in the basis of:
Global Autologous Cell Therapy Market, by Source
Global Autologous Cell Therapy Market, by Application
Global Autologous Cell Therapy Market, by End-user
Global Autologous Cell Therapy Market, Region
Explore Transparency Market Research's award-winning coverage of the global Healthcare industry:
Autoimmune Disease Diagnostics Market- the global autoimmune diseases diagnostics market is expected to exhibit a CAGR of 3.8%. The global autoimmune disease diagnostics market is likely to reach US$17.06 bn by 2023. The stiff price competition among players is expected to impact the growth of the market in a negative way.
Stem Cells Market- The global market for stem cells is projected to reach a value of US$270.5 bn by the end of 2025. The market is likely to exhibit a strong 13.80% CAGR between 2017 and 2025
Cell Therapy Market-The study reports an insight about the global cell therapy market, along with its current and the past market situation. This enables the customers to comprehend the situation before entering or investing in the market. The report gives driving components fueling the development of the market, restrictions which are probably going to limit the market development, and so forth.
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Growing Number of Patients Suffering From Neurological Disorder to Support the Growth of Global Autologous Cell Therapy Market, TMR - PRNewswire
The Best Tea Tree Oil Balm That You Can Buy on Amazon – STYLECASTER
For anyone who has been struggling with skin issues, it can be very frustrating. Whether you have cracked cuticles that the most high-end moisturizer wont heal or eczema, it can be difficult to find a cure-all that helps fight issues across the board. The world might not have a cure for everything yet, but tea tree oil balm does work wonders on many skin issues. If youre tired of using harsh chemicals to try to fix your problems, you might want to try tea tree oil balm.
You only need a little bit of the balm, which is harder and less flexible than a cream or oil, to cover the afflicted area. Tea tree oil balm usually does not go on greasy and stays put all day long to heal and restore the skin. It works on many problems, including cracked cuticles, dry skin, severely chapped lips, calluses, athletes foot, bug bites, psoriasis, eczema, hives and itchy skin. Basically, tea tree oil balm is great to keep on your bedside or in your purse for any skin emergency. You can even use it proactively, because it can serve as a great light-weight moisturizer. It cant hurt to keep boosting your skins protective barrier.
We found the best tea tree oil balms thatll provide relief to your stressed out skin. These balms use natural ingredients to help your skin. This is the MVP of natural skincare.
Our mission at STYLECASTER is to bring style to the people, and we only feature products we think youll love as much as we do. Please note that if you purchase something by clicking on a link within this story, we may receive a small commission of the sale and the retailer may receive certain auditable data for accounting purposes.
This small but mighty 60-gram tin works on just about everything from cracked cuticles to eczema. Absorbent and not greasy, this balm heals and softens skin. Its tiny enough to fit in a small purse, so you can take it with you wherever you go. Chamuels balm is made of tea tree oil, green tea, peppermint oil, lemon oil, olive oil and beeswax. It doesnt contain any harsh chemicals, parabens or artificial ingredients. The balm has a slight fresh, citrus smell, but it isnt overpowering.
Image: Amazon
This Wonder Balm is primarily made of oils, including tea tree, eucalyptus, macadamia, olive oil and beeswax. Its designed to restore your skins protective barrier and provide relief of your skin. It also heals dry skin, especially on your feet, hands and elbows. When you sweat, your creams often sweat away but that isnt the case for this balm. The lightweight, non-greasy formula stays put even when youre moving. This cream doesnt contain any preservative, parabens or petroleum.
Image: Amazon
This balm includes tea tree oil, fruit stem cells, almond oil, eucalyptus oil and lavender oil. The balm works hard to restore balance and repair your skin. It can help with annoyances such as razor burn, dry ashy skin, psoriasis, severely chapped lips and bug bites. You do need to use a little bit of elbow grease to get this hard, firm balm out of the container, but it does work well after that.
Image: Amazon
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The Best Tea Tree Oil Balm That You Can Buy on Amazon - STYLECASTER
Novadip Biosciences Reports Positive Interim Analysis of Phase I/II Bone Non-Union Study with NVD003 – GlobeNewswire
Novadip Biosciences Reports Positive Interim Analysis of Phase I/II Bone Non-Union Study with NVD003
Mont-Saint Guibert, Belgium, 13 May, 2020: Novadip Biosciences (Novadip or the Company), a clinical-stage biopharmaceutical company leveraging its proprietary tissue regeneration technology platform, today announces positive data from the interim analysis of its Phase I/IIa clinical trial for autologous NVD-003 in adults with non-healing fracture of the lower limb.
NVD-003 is a novel autologous cell-based osteogenic (bone healing/[bone forming]) product that has been generated from Novadips proprietary 3M tissue regeneration platform. This platform is aimed at healing damaged tissues by restoring their natural physiology and consists of a 3-dimensional, scaffold-free extracellular matrix (ECM), utilizing differentiated adipose-derived stem cells (ASCs) to restore the physiology of natural healing. NVD003 presents as a scaffold-free 3D implant to fill critical-size bone defects where healing is compromised.
This phase I/II study is investigating in five European centers the potential of NVD-003 to promote bone union in nine adults with a non-healing fracture of the lower limb. There was 100% manufacturing success for NVD-003 and grafting surgery was completed successfully in all patients without deviating from standard medical practice. To date, with a median of 12 months post-treatment, no NVD003 related safety signal has been reported. Further exploratory analysis performed on data from the first five patients to complete a six month follow up showed a strong positive trend in radiological healing with confirmed bone formation for all patients and radiologically confirmed union for three of the patients.
Prof. Gunnar Anderson (MD, PhD), Professor and Chairman Emeritus of the Department of Orthopedic Surgery at Rush University Medical Center, Chicago, Illinois and Chairman of the Scientific Advisory Board commented: The early results of this study are remarkable both clinically and for the patients and we look forward to replicating these in a larger group in the future. It is hugely encouraging that we may potentially have a future solution for these patients with unmet needs.
Dr. Denis Dufrane (MD, PhD), Chief Executive Officer, Chief Scientific Officer commented: We are encouraged by the data from this interim analysis, which demonstrates the potential of our tissue regeneration 3M3 platform to restore natural healing processes in patients with reputedly difficult to treat bone defects. We look forward to further progressing NVD-003s clinical program in bone non-union and in patients with other similar conditions with no effective treatment option and hope to provide full study results in 2025.
NVD-003 is also in clinical stage for congenital pseudarthrosis of the tibia (CPT), a rare and disabling pediatric condition with very limited treatment options and has demonstrated clinical proof-of-concept in case studies.
Novadips tissue regeneration platform drives several new classes of product candidates with an initial focus on autologous cell therapies for critical size tissue reconstruction. Allogeneic therapeutics are in development for prevalent and complex tissue defects for bone and skin tissue and exosomes/miRNA-based therapeutics are being developed for immediate (off-the-shelf) clinical use.
- End -
Notes to editors
Novadip Biosciences
Novadip Biosciences is a clinical stage biopharmaceutical company leveraging its unique 3D tissue regeneration technology platform to generate multiple product candidates to address hard and soft tissue reconstruction for patients who have limited or no treatment options. The companys proprietary 3M3 platform is a 3-dimensional, extracellular matrix that utilizes adipose-derived stem cells to deliver highly-specific growth factors and miRNAs to mimic the physiology of natural healing and creates a range of products that address specific challenges in tissue regeneration. Novadips initial focus is on critical size bone reconstruction. The company is also applying its 3M3 platform to develop truly novel off-the-shelf/allogeneic therapies to address more prevalent tissue defects and miRNA/exosome products for broader indications. For more information, visit http://www.novadip.com .
For further information, please contact:
Novadip Biosciences
Denis Dufrane
Chief Executive Officer, Chief Scientific Officer
+32 (10) 779 220
For media enquiries:
Consilium Strategic Communications
Chris Gardner, Matthew Neal, Angela Gray
+44 (0) 20 3709 5700
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Novadip Biosciences Reports Positive Interim Analysis of Phase I/II Bone Non-Union Study with NVD003 - GlobeNewswire
Protocol Management, Off-the-Shelf Therapies Help Bring CAR T Into More Settings – Targeted Oncology
Carlos R. Bachier, MD
Chimeric antigen receptor (CAR) T-cell therapies quickly burst into the spotlight of hematology-oncology disease management because of their potential to illicit deep and durable responses from patients whose disease is relapsed or refractory to multiple previous lines of therapy. Relevant professional meetings and oncology publications exploded with research and news about CAR T cells, and this cellular therapy strategy is now being explored across hematologic and solid malignancies.
CAR T cells are a scientific revolution, Tania Jain, MBBS, assistant professor of oncology at Johns Hopkins University in Baltimore, Maryland, said in an interview with Targeted Therapies in Oncology (TTO). They have brought about a paradigm shift in terms of how were treating patients.
The 2 currently FDA-approved CAR T-cell therapies, axicabtagene ciloleucel (Yescarta) and tisagenlecleucel (Kymriah), are both indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma; additionally, tisagenlecleucel is approved for patients up to 25 years with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).1-3 With a second wave of approvals likely on the horizon for therapies such as lisocabtagene maraleucel (liso-cel) and idecabtagene vicleucel (bb2121), CAR T is gaining traction and will likely play an increasingly prominent role in the future treatment paradigm in oncology.
CAR T-cell therapy administration is largely limited to the inpatient setting at both academic institutions and large accredited cancer centers, making such treatments unavailable to most patients. Other challenges with this type of therapy include its potential to cause serious toxicities resulting in organ damage and death.4
David G. Maloney, MD, PhD
Due to the promising efficacy of these agents, investigators have been working toward viable solutions to bring CAR T-cell therapies to more patients by alleviating difficulties associated with therapy delivery and patient care.
CAR T-cell therapies, both those currently approved and the many being explored in late-phase clinical trials, are produced from autologous T cells obtained from the patient receiving therapy. This personalization has led to tremendous success, yet it is a large part of why CAR T-cell therapy use remains limited to a select group of patients.
Time is an important consideration for patients who have experienced multiple relapses and may be too weakened by numerous lines of prior therapy to wait several weeks for the CAR T-cell manufacturing process. The effects of previous treatments or the disease itself can also present challenges, as manypatients are rendered lymphopenic and may be unable to produce enough T cells for harvesting. Roadblocks may remain for patients who are not limited by these factors; manufacturing success and effectiveness of the CAR T-cell product can be negatively influenced by disease-related dysfunctions of patients T cells.4
A new option, off-the-shelf CAR T-cell products, may help solve these problems. These premade products are manufactured using allogeneic donor cells (instead of autologous cells from the patient), and they present immediate advantages to clinicians, such as immediate availability, opportunity for product standardization, and decreased cost.5
The advantages [include] being able to access the cellular therapy in real time, as opposed to autologous products that havetobe manufactured,Craig S. Sauter, MD, clinical director of the Adult Bone Marrow Transplant Service at Memorial Sloan Kettering Cancer Center in New York, New York, explained in an interview withTTO. This is particularly important for patients who are not responding to therapy, which is a current requirement for treatment with CAR T cells, he added.
Findings from a phase I trial (NCT01430390) in patients with relapsed or refractory B-cell malignancies showed that patients with non-Hodgkin lymphoma (NHL) experienced durable responses with an Epstein-Barr virusspecific cytotoxic lymphocyte CAR product derived from cells harvested from third-party donors (rather than from their more precisely matched stem cell donors). All 4 patients with NHL and a single patient with chronic lymphocytic leukemia, who were treated with third-party cells, remained disease free and alive at the time of analysis, with a median follow-up of over 2 years.6
The advantages [of this type of therapy are] that it eliminates the need for apheresis [and] shipping cellular products back and forth. [Instead, clinicians] have a pharmaceutical product on the shelf for access, Sauter, who was an author on the trial, said. Another notable product being investigated in clinical trials is UCART19, an allogeneic engineered anti CD19CAR T-cell product, which is being evaluated in the phase I CALM trial in adult patients with relapsed or refractory B-cell ALL (NCT02746952) and in the phase I PALL trial of pediatric patients with relapsed or refractory CD19-positive B-cell ALL (NCT02808442). Other off-the-shelf agents are described in theTABLE.5
Issues with inpatient CAR T-cell therapy administrationinclude high demands on health care resources and strain on patients and their families. Moving treatment to the outpatient setting has the potential to reduce this strain; however,clinicians taking over care of patients receiving CAR T-cell therapy must be prepared with the proper resources to identify and manage adverse events associated with therapy.
One of the most notable risks to patients receiving CAR T-cell therapy is cytokine release syndrome (CRS), a systemic inflammatory response that is characterized by increased serum levels of inflammatory cytokines, fever, hypotension, hypoxia, and organ dysfunction.4 [CAR T] can also lead to neurological events and can cause confusion and, in some patients, seizures,Carlos R. Bachier, MD, Director of Cellular Research at Sarah Cannon Cancer Center in Nashville, Tennessee, explained in an interview with TTO.
Regardless of the infusion setting, patients require close monitoring in the hours and days following therapy administration. A review byLucrecia Yez, PhD, MS, and colleagues stated that key criteria for treating patients in the outpatient setting include an educated caregiver and necessary infrastructure allowing for outpatient visits plus adequate emergency and intensive care unit (ICU) access. Patients followed as outpatients must be given twice-daily temperature checks for a minimum of 14 days following treatment and preferably extending up to 3 to 4 weeks following infusion. Anysigns of back pain, skin rash, dizziness, chills, shortness of breath, chest pain, tachycardia, or neurological events that may indicate neurotoxicity or signs of CRS must be reported immediately so treatment can begin as quickly as possible.7
Because of the risk of CRS and neurotoxicity, both FDA-approved agents are restricted under the Risk Evaluation and Mitigation Strategy, an FDA-mandated program that builds in caution for use of agents with serious safety concerns.8,9 Therefore, 2 doses of tocilizumab (Actemra), an interleukin (IL)-6 receptor antagonistthat was approved in 2017 for management of CRS associated with CAR T-cell therapy,1,4 should be on hand for each patient before the infusion of CAR T cells. Steroids have also demonstrated efficacy against CRS, but concernssurrounding CAR T-cell suppression with these agents have established them as a second-line choice after tociluzumab.9
Immune effector cellassociated neurotoxicity syndrome (ICANS) is a group of neurologic symptoms associated with treatments such as CAR T-cell therapy. Predisposing factors include younger age, higher tumor burden, high levels of pretreatment inflammation, and history of early or high-grade CRS. Treatments for complications of ICANS vary. Some centers may prescribe prophylactic antiepileptic medications, such as levetiracetam, to prevent seizures in patients with grade 2 or higher neurologic events. AntiIL-6 therapy can be considered in patients with concurrent CRS, but corticosteroids are the preferred regimen in those with neurotoxicity alone.9
In February of this year, the investigational CAR T-cell product liso-cel was granted priority review by the FDA for the treatment of adult patients with relapsed or refractory large B-cell lymphoma who had undergone at least 2 prior therapies.10 Investigators believe that liso-cel therapy may have a place in a broad range of patients and in the outpatient setting.11
It turns out liso-cel has a low incidence of [CRS and ICANS], and they occurred relatively late compared with other products, said Bachier. Because of this low incidence, the strategy was to deliver liso-cel in an outpatient setting.
The feasibility of liso-cel administration on an outpatient basiswas evaluatedby Bachier and colleagues, and the results were presented at the 2020 Transplantation & Cellular Therapy Meetings of the American Society for Transplantation and Cellular Therapy and the Center for International Blood & Marrow Transplant Research, held February 19 to 23, 2020, in Orlando, Florida.12
The authors analyzed data from 3 clinical trials of liso-cel, with a focus on the subset of participants who were treated as outpatients. The included trials were the phase I TRANSCEND-NHL-001 (NCT02631044) and phase II OUTREACH (NCT03744676) trials in patientswhohadundergone at least 2 lines of prior treatment, as well as the PILOT study (NCT03483103), which examined liso-cel as second-line therapy in patients who were ineligible for autologous hematopoietic stem cell transplant because of age, organ function, or ECOG performance score. All 3 studies allowed outpatienttreatment, with some patients receiving their therapy in the nonuniversity setting.
This clinical trial included sites that were not a part of a university but had experience treating patients for stem cell transplant, Bachier said. Some of these sites that participated were notyour traditional university centers that had traditionally been involved in the development of these therapies.
Much caution was required in order to maximize patient safety and treatment efficacy. The approach of doing CAR T-cell therapy, in general, in the outpatient setting requires a robust clinical ability of the centers, said coauthor David G. Maloney, MD, PhD, medical director of Cellular Immunotherapy at the Immunotherapy Integrated Research Center of Fred Hutchinson Cancer Research Center in Seattle, Washington, in an interview. We were able to get people safely to the hospital, and it was rare that you would have to do escalation of care when people were admitted. Most of the time, patients could bemanagedand wereout of the ICU, withrare exceptions. But again, you still have to have the wherewithal to get patients to the ICU pot entially for aggressive care if needed.
Results of the analysis of outpatient data from the 3 trials showed that rates of toxicity and response were similar to those previously reported for the entire patient cohort (both inpatients and outpatients) of the TRANSCEND-NHL-001 trial.
Based on these results, the indication is that you can deliver [liso-cel] in the outpatient setting and the outcomes are good compared with those treated in the inpatient setting, said Bachier. Aside from that, it also showed that liso-cel could be safely administered outside of university programs and in more community-based programs, most of them being aligned [with] or part of stem cell and bone marrow transplant programs.
When planning or setting up a CAR T-cell therapy outpatient program, investigators anticipate possible barriers to successfultreatment. The greatest barrier, according to Bachier, is access to physicians and staff who are knowledgeable and trained to manage toxicities related to CART-cell therapy. These therapies still should not, in my opinion, be delivered [by clinicians in] community centers that do not have the expertise to deliver the therapies safely, he said.
Maloney added that centers should be required to have the ability to triage patients 24/7 and allow for patients to be directly admitted to the hospital if needed. In the case of the analysis of outpatient data from the 3 liso-cel trials however, he said, We found that around 30% to 40% of patients did not actually ever require hospitalization, whichis quite interesting. Most of the 60% to 70% of patients who were hospitalized were admitted for fever, he added.
In addition, sites must gain accreditation and approval, Jain pointed out.
Every center that intends to do CAR T-cell therapy is first approved by each of the companies [that manufacturethese agents], Jain said. The centers also have to be approved by FACT [Foundation for the Accreditation of Cellular Therapy], which is the same organization that approves centers for allogeneic stem cell transplant. These are some of the largest things that a center needs to go through, which takes care of things like developing standard practices and other guidelines to make sure that these [therapies] are used safely and appropriately.
As investigators and oncologists explore the feasibility of moving CAR T-cell therapy into more settings, 2 questions arise: What settings have on this therapy?
What type of training and skills do clinicians need? Like other clinicians, Sauter has concerns about new allogeneic cellular therapies,andhe hopes future research will focus on mitigating these challenges. The concern would be that these are not autologous products and there is the risk of rejection from the host immune system, he said. Strategies to circumnavigate that risk are at the forefront of investigationin off-the-shelf CAR T cells.
The research is not stopping with CAR T-cell therapy,though. Were seeing a lot of new molecules coming in that will be challenging the roles of CAR T cells, [such as] specific antibodies, which may even work in cases of CAR T-cell failure, Maloney said. We are still learning how to make those more effective and safer.
References:
1. FDA approves tisagenlecleucel for B-cell ALL and tocilizumab for cytokine releasesyndrome.FDAwebsite.PublishedAugust30,2017.AccessedApril14, 2020. bit.ly/2RC4eQ8
2. FDA approves axicabtagene ciloleucel for large B-cell lymphoma. FDA website. Published October 18, 2017. Accessed April 14, 2020. bit.ly/2yYIQOp
3. FDA approves tisagenlecleucel for adults with relapsed or refractory large B-cell lymphoma. FDA website. Published May 1, 2018. Accessed April 14, 2020. bit.ly/34zPoi8
4. Rafiq S, Hackett CS, Brentjens RJ. Engineering strategies to overcome the current roadblocks in CAR T cell therapy. Nat Rev Clin Oncol. 2020;17(3):147167. doi: 10.1038/s41571-019-0297-y
5. DepilS,DuchateauP,GruppSA,MuftiG,PoirotL.Off-the-shelfallogeneic CAR T cells: development and challenges. Nat Rev Drug Discov. 2020;19(3):185199. doi: 10.1038/s41573-019-0051-2
6. Curran KJ, Sauter CS, Kernan CS, et al. Durable remission following off-theshelf chimeric antigen receptor (CAR) T-cells in patients with relapse/refractory (R/R) B-cell malignancies. Presented at: 2020 Transplantation & Cellular Therapy Meetings; February 19-23, 2020; Orlando, FL. Abstract 120. bit.ly/2ufDYCu
7. Yez L, Snchez-Escamilla M, Perales MA. CAR T cell toxicity: current managementandfuturedirections. Hemasphere.2019;3(2):e186.doi:10.1097/ HS9.0000000000000186
8. Risk evaluation and mitigation strategies | REMS. FDA website. Updated August 8, 2019. Accessed April 14, 2020. bit.ly/2ykhLVt
9. JainT,BarM,KansagraAJ,etal.UseofchimericantigenreceptorTcell therapy in clinical practice for relapsed/refractory aggressive B cell non-Hodgkin lymphoma: an expert panel opinion from the American Society for Transplantation and Cellular Therapy. Biol Blood Marrow Transplant. 2019;25(12):2305-2321. doi: 10.1016/j.bbmt.2019.08.015
10. U.S. Food and Drug Administration (FDA) accepts for Priority Review Bristol-Myers Squibbs Biologics License Application (BLA) for lisocabtagene maraleucel (liso-cel) for adult patients with relapsed or refractory large B-cell lymphoma. News release. Bristol-Myers Squibb; February 12, 2020. Accessed April 15, 2020. bit.ly/37ruQbs
11. Helwick C. Strong activity shown for lisocabtagene maraleucel CAR T-cell therapy in aggressive large B-cell lymphoma. ASCO Post website. Published February 25, 2020. Accessed April 15, 2020. bit.ly/3eoD0pT
12. Bachier CR, Palomba ML, Abramson JA, et al. Outpatient treatment with lisocabtagene maraleucel (liso-cel) in 3 ongoing clinical studies in relapsed/refractory (R/R) large B cell non-Hodgkin lymphoma (NHL), including second-line transplant noneligible (TNE) patients: TRANSCEND NHL 001, OUTREACH, and PILOT. Presented at: 2020 Transplantation & Cellular Therapy Meetings; February 19-23, Orlando, FL. Abstract 29. bit.ly/37I7DC9
Link:
Protocol Management, Off-the-Shelf Therapies Help Bring CAR T Into More Settings - Targeted Oncology
Growing Number of Patients Suffering From Neurological Disorder to Support the Growth of Global Autologous Cell Therapy Market, TMR – P&T Community
- The global autologous cell therapy market is expected to witness a massive 18.1% CAGR during the tenure of 2019 to 2029
- During the tenure of 2019 to 2027, the global autologous cell therapy market shall rise from 7.5 Bn in 2018 to US$ 34.7 Bn by the end of 2027
ALBANY, New York, May 11, 2020 /PRNewswire/ -- As a result of growing pandemic of COVID-19, the pharmaceutical industry is investing a major amount in research and development of an effective vaccine that can help the doctors to save lives and help controlling the pandemic. As per a recent analysis by Transparency Market Research over pharmaceutical sector, it was found that the global autologous cell therapy market is witnessing a major push. The market is projected to grow exponentially during the tenure of 2019 to 2027 and is expected to witness a substantial 18.1% CAGR during this tenure. Moreover, the global autologous cell therapy market is expected to register a value of US$ 34.7 Bn by the end of 2027, says a recent report by Transparency Market Research.
"COVID-19 has impacted the economy at global level. With the death tolls still on the rise in developed and developing countries, the pandemic nowhere seems to get stop. However, the pharmaceutical sector is constantly investing in research and development. Nevertheless, the industry is majorly investing in autologous cell therapyto find an effective cure for CORONA Virus. Owing to these research and development, the global autologous cell therapy market is projected to grow exponentially during the tenure of 2019 to 2027" Transparency Market Research.
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Major Finding in Global Autologous Cell Therapy Market Study
Explore the latest study on global autologous cell therapy market under the title: Autologous Cell Therapy Market (Source - Bone Marrow and Epidermis; Application - Neurology, Orthopedics, Cancer, Wound Healing, CVD, and Autoimmune; End User - Hospitals, Ambulatory Centers, and Research Centers) - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast 2019 2027 at https://www.transparencymarketresearch.com/report-toc/715
Major Drivers Propelling the Growth of Global Autologous Cell Therapy Market
Growing cases of Neurological Disorders to Propel the Growth
The world is witnessing a massive growth in the number of patients suffering from neurological diseases. The report by Transparency Market Research states that there are more than 50 Mn people suffering from autoimmune disorder which can cause a painful death. In order to develop an effective drug that can help the neurological patients, the pharmaceutical industry is investing massive in autologous cell therapywhich as a result is propelling the growth of global autologous cell therapy market during the tenure of 2019 to 2027.
Strong Government Support to Boost the Growth of the Autologous Cell Therapy Market
Governments across the globe are encouraging pharmaceutical industry to develop an effective cure for Parkinson's, nervous breakdowns, and most importantly COVID-19. This has significantly helped the players to develop new drugs. Owing to this support, the global autologous cell therapy market shall witness a substantial growth during the tenure of 2019 to 2027, states the report by Transparency Market Research.
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Major Challenges Mentioned in the Global Autologous Cell Therapy Market
The major challenge that might impede the growth of global autologous cell therapy market is the cost of the therapy. Since the cost of therapy is quite high, the some of the patient might not be able to afford it which might deplete the growth of global autologous cell therapy market during the tenure of 2019 to 2029. However, with ongoing research and development in the pharmaceutical industry, there are high chances that the world might see a cost effective therapy in the global autologous cell therapy market in future.
Global Autologous Cell Therapy: Regional Analysis
North America shall account for the largest share in the global autologous cell therapy market in future. It is noticeable that the regional front of the global autologous cell therapy market was dominated by this particular region in 2018. This dominance is the result of improving healthcare infrastructure, technological development and supportive government efforts. Owing to these factors the global autologous cell therapy market is expected to be dominated by North America during the tenure of 2019 to 2027.
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Competitive Analysis
The global autologous cell therapy market is highly progressive yet highly consolidated. The nature of the market is the result of presence of AA handful of prominent players. However, due to this the new players are unable to enter the global autologous cell therapy market. To overcome this situation, the new players are merging and collaborating with the established players of global disposable face mask market.
The global autologous cell therapy market is segmented in the basis of:
Global Autologous Cell Therapy Market, by Source
Global Autologous Cell Therapy Market, by Application
Global Autologous Cell Therapy Market, by End-user
Global Autologous Cell Therapy Market, Region
Explore Transparency Market Research's award-winning coverage of the global Healthcare industry:
Autoimmune Disease Diagnostics Market- the global autoimmune diseases diagnostics market is expected to exhibit a CAGR of 3.8%. The global autoimmune disease diagnostics market is likely to reach US$17.06 bn by 2023. The stiff price competition among players is expected to impact the growth of the market in a negative way.
Stem Cells Market- The global market for stem cells is projected to reach a value of US$270.5 bn by the end of 2025. The market is likely to exhibit a strong 13.80% CAGR between 2017 and 2025
Cell Therapy Market-The study reports an insight about the global cell therapy market, along with its current and the past market situation. This enables the customers to comprehend the situation before entering or investing in the market. The report gives driving components fueling the development of the market, restrictions which are probably going to limit the market development, and so forth.
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Hybrid lobster species discovered with new genetic test Earth.com – Earth.com
In a new study from the University of Exeter, researchers have identified a hybrid lobster species with both American and European genes.
According to study co-author Dr. Charlie Ellis, the discovery has potentially concerning implications for the lobster industry and conservation efforts, and further research is needed to assess the extent of the threat.
Lobsters imported from North America have been washing up on European shores in recent years. Experts have feared that the American lobsters may establish themselves as a native species or spread disease.
There have also been concerns about the negative effects of hybridization, but lab studies suggested that the European and American lobsters were not likely to mate.
Now, the offspring of a female American lobster found in a fjord in Sweden have been genetically identified as being clearly distinct from both European and American lobsters.
We had just developed a genetic test for seafood traceability that could separate any American lobsters mislabeled as more expensive European equivalents once theyve been cooked and shell coloration is no longer a useful indicator of the species, said Dr. Ellis.
What we found when we tested these offspring is that they came out exactly in the middle of this separation half American and half European so these lobsters were hybrids.
Until recently, it was thought that American and European lobsters would avoid crossbreeding, but this introduced American female has mated with a native European male, probably because she was unable to find an American male.
We now need to check whether any mature adult hybrids are fertile, because if they are then they have the ability to spread these unwanted American genes far and wide across our native lobster stocks.
According to the researchers, the study highlights the vital use of genetics to distinguish hybrid lobsters which might look almost identical to a pure strain.
It is particularly concerning that we seem to have found American lobster genes in one of our lobster reserves, said study co-author Linda Svanberg.
The better news is we now have this genetic tool to test lobsters or their eggs for hybridisation, so we can use it to track the spread of these alien genes to assess how big a threat this presents to our native lobster species, said study lead author Dr. Jamie Stevens.
For a range of conservation reasons, including potential contact with American lobsters, the researchers advise that the general public should never release a marketed lobster back into the wild.
Although we appreciate that all animal-lovers have concern for the fate of individual animals, in this case the rescue of one animal might endanger the health of the entire wild population, so once a lobster has entered the seafood supply chain thats where it should stay, said Dr. Tom Jenkins.
The study is published in the journal Scientific Reports.
By Chrissy Sexton, Earth.com Staff Writer
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Hybrid lobster species discovered with new genetic test Earth.com - Earth.com
Study analyses risks of maternal infections, neurodevelopmental disorders in offspring – Devdiscourse
With the help of a mouse model, researchers have found that the immune responses in a female before pregnancy can help predict how her offsprings are to have behavioural deficits if the immune system is activated during pregnancy. The results of the study could help resolve what role serious infections during pregnancy play in the later development of conditions such as autism and schizophrenia in the offspring.
The researchers from the Center for Neuroscience at the University of California, Davis co-authored the study findings published in the journal Brain, Behavior, and Immunity. Both genetics and a variety of environmental risk factors are thought to play a role in mental illness, said Professor Kim McAllister, director of the Center for Neuroscience and senior author on the paper.
"Most pregnancies are resilient, although the risk from maternal immune activation is low, it could provide a way into the underlying problems that lead to schizophrenia or autism," she said. "Our research focuses on how to predict which pregnancies are at risk and discover new ways to intervene and prevent disease in offspring."
The first evidence for a role for maternal infection in mental and developmental disorders came from the influenza epidemic of 1918, McAllister said. Epidemiological studies 15 to 20 years later of children who were in gestation at the time showed an increase in these disorders. Other evidence comes from animal studies.Apart from influenza, a wide variety of viruses and bacteria have been implicated in maternal immune activation. So the effect is more likely due to the mother's reaction to infections than with the infectious organism itself.
To reproduce this in mice, McAllister's team doses pregnant mice with a molecule called polyinosinic:polycytidylic acid, or poly (I:C), which is double-stranded RNA, the genetic material for many viruses including influenza and coronaviruses. The immune system recognizes poly (I:C) as if it were a virus and triggers an immediate inflammatory response, especially releasing a molecule called interleukin-6, or IL-6.
The mice continue with the pregnancy and when the offspring are about 2 months old, the researchers test them for behavioural abnormalities, such as repetitive behaviours or freezing in place. Professor Judy Van de Water, an immunologist at the UC Davis School of Medicine and part of Estes' thesis committee, suggested looking at baseline immune reactivity in the mice before they became pregnant.
When they did that, the team found that the IL-6 response of a particular mouse to poly (I:C) before it became pregnant could predict the likelihood of behavioural problems in offspring if the mouse were treated with poly (I:C) later during pregnancy. "People assume that their mice are all the same, but there is clearly a wide range of baseline immunoreactivity," McAllister said. That baseline immunoreactivity turns out to predict resilience or susceptibility to immune activation during pregnancy.
"We can dose them with poly (I:C) and look at the IL-6 response and predict which ones will have affected offspring if we treat them during pregnancy," she said.With a reliable model for resilience and susceptibility, researchers can start to work out what genes and proteins involved in brain development are affected by immune activation and how this could lead to neurodevelopmental disorders. "The next steps are to figure out what it is that is different about those mice," McAllister said.
"Now that we can predict which mice are at risk, we want to determine how specific patterns of immune signalling in the mom cause distinct outcomes in offspring. We are hoping to figure out how maternal infection can lead to no problem in many pregnancies and to a range of distinct diseases in offspring from other pregnancies," McAllister added. Secondly, it could lead to biomarkers for identifying pregnancies at higher risk from infections and taking steps to protect mothers by vaccination or treatment.
That will likely involve further work in mice followed up with experiments in nonhuman primates before moving into human studies. (ANI)
A Failed Deception: The Early Days of the Coronavirus Outbreak in Wuhan – DER SPIEGEL
On the morning of Dec. 20, 2019, the Chinese fish monger Chen Qingbo was cleaning out his stand at the market, completely unaware that he would soon become the focus of intense scientific research, that he was carrying a virus within him of a kind the world had never seen before. He was unaware that his fate was linked closely with that of all of humanity.
He had been up since 5 a.m. and had already made deliveries to his primary customers, including a number of hotels and restaurants in the Chinese metropolis of Wuhan. The Huanan retail and wholesale market, located not far from the train station, had been his base of operations for the last 10 years. By around 11 a.m., he had finished his work for the day and climbed into his Chevrolet for the short drive from the market to his home.
Chen is a sturdily built 42-year-old with a buzz cut and round glasses, married with two children. His small company employs three workers and he owns two delivery trucks, an apartment in Wuhan and two other apartments in his home province of Fujian. He works every day of the week, including weekends. "But on that Friday," he says, "I felt strangely tired and despondent."
Indeed, he was feeling so poorly that afternoon that he dropped by a doctor's office in his neighborhood and he received an infusion, not an uncommon treatment in China. He then went back to work on Saturday and again on Sunday and Monday, but he was feeling worse by the day, with the doctor suspecting a viral infection. Then, on Tuesday, Chen could no longer make it to the market: He had developed a fever and a cough. On Thursday, he checked into the Central Hospital of Wuhan.
Just four days later, Chen was fighting for his life. From the sample that doctors took from his lungs, a laboratory in Shanghai ultimately managed to sequence for the very first time the complete genome of an unknown virus: SARS-CoV-2, the cause of the pandemic that would ultimately spread across the entire world.
On that Dec. 20 in Wuhan, the day that Chen began feeling ill, there was nothing to indicate that a catastrophe was on the horizon. Like all cities in China, Wuhan was preparing for the Chinese New Year's festival at the end of January, an atmosphere comparable to that in Europe ahead of the Christmas holidays - days of pleasant anticipation combined with hectic preparations. Companies were planning parties while workers and students were buying train tickets back home. Communist Party officials also had plenty to do: In early January, city and provincial parliaments were scheduled to meet, an annual ritual.
Wuhan is a vast metropolis, with a population larger than that of cities like New York, London and Paris. It is a place where important rail lines and shipping routes meet, a wealthy, modern city on the banks of the Yangtze River with an impressive skyline and an historical town center built in the European colonial style. The city's politicians and business leaders have long hoped to see Wuhan on a par with other huge Yangtze megalopolises like Shanghai, Nanjing and Chongqing.
Instead, the name Wuhan has become synonymous the world over with a pandemic. That day in December 2019, it became the birthplace of a crisis that can only be compared with the terror attacks of Sept. 11, 2001. And with the 2008 financial crisis, the consequences of which have already been overshadowed by what we are experiencing today.
The novel coronavirus has thus far killed more than 260,000 people officially and has plunged the global economy into an historical recession. It has changed the day-to-day lives of people around the world, fundamentally altered citizens' relationship with the state and reshaped geopolitics.
The article you are reading originally appeared in German in issue 20/2020 (May 09, 2020) of DER SPIEGEL.
The political and economic consequences of the coronavirus are so significant that the entire world order may ultimately be transfigured. It may slow globalization, or it may accelerate it. It could catapult the world out of the industrial age into a new era. The only thing that is certain is that change is coming.
More than four months after fish monger Chen became one of the very first people to come down with the respiratory illness later named COVID-19, there are a number of theories and opinions in circulation about the origins and spread of the illness. DER SPIEGEL has reconstructed events in Wuhan in an effort to learn how the outbreak could have happened and what took place in the early days in the city's hospitals and health agencies. And to learn whether the global pandemic could have been prevented if officials, doctors and politicians had behaved differently. In short, to learn who might share the blame for this pandemic.
This reconstruction is based on numerous discussions and meetings, on reporting in Wuhan itself but also on reporting by Chinese journalists. A complete picture can only be provided by an in-depth international investigation of the kind being demanded by experts and politicians around the world - an investigation that Beijing has thus far resisted. But it can already be said with certainty that mistakes were made in Wuhan and that the global spread of the disease could, at the very least, have been slowed.
It isn't known when and where the first person became infected with SARS-CoV-2. But it is considered extremely likely that the precursor to the pathogen comes from bats and based on genetic analysis, it is believed that the virus jumped to humans only one single time, at some point in fall 2019.
A traditional market in Wuhan: The virus only jumped to a human on one single occasion.
That is rather unusual. It is generally the case that a longer process of genetic adaptation is necessary before a virus that originates in animals can be passed from human to human. Generally, humans repeatedly become infected by animals before a pathogen mutates such that it can be passed from person to person. But SARS-CoV-2 followed a different path. Researchers believe that a specific genetic sequence is responsible, one that joined the genome that produced SARS-CoV-2 predecessor completely by chance. It is that sequence that has made it so easy for the virus to spread.
Researchers have two hypotheses for the beginning of the pandemic: Either this genetic sequence was added to the virus when it was still reproducing in its animal host - whether it be bats, pangolins or raccoon dogs so that the first person who became infected was immediately able to pass it along. Or a precursor was circulating unnoticed for months, but wasn't particularly contagious before the new sequence was added.
Either way, close contact between humans and animals provide ideal conditions for viruses to jump to humans. And those conditions were present at a wildlife market in Wuhan.
On Dec. 26, the day when the fish monger Chen Qingbo checked into the Central Hospital of Wuhan, the pulmonologist Zhang Jixian, 54, had her first encounter with the virus at a different clinic in Wuhan. An elderly patient was suffering from a fever, a cough and breathing difficulties and tests for influenza and other, similar illnesses had all come back negative. Dr. Zhang ordered a CT scan of the patient's lungs and found that she was suffering from a severe and unusual form of pneumonia.
One day later, the neurological department asked Zhang for assistance with an elderly patient experiencing similar symptoms. His CT scan had also revealed severe pneumonia. The doctors soon figured out that the male patient and the female patient were married. "I felt something was wrong," Zhang would later tell the state-run news agency Xinhua.
The doctor learned that the son of the two patients had brought them to the hospital and she convinced him to submit to a CT scan of his own lungs. "He resisted initially," according to Zhang. "He had no symptoms and thought we wanted to get him to undergo an expensive procedure."
Once the scan was performed, though, it revealed the same lesions on the lungs that his parents had. For Zhang, it all pointed to a "contagious disease," and after a few more tests, she was convinced. "This was not an ordinary virus." That same day, she reported her findings to the authorities.
People suffering from the same symptoms were showing up at other hospitals in the city as well. Most had one thing in common: Like Chen Qingbo, they had been traders, suppliers or customers of the Huanan market.
Before it was closed down, the market consisted of two large halls separated by a broad road. Each hall contained dozens of stands and Chen's stand was in the eastern part of the market, where primarily fish and shellfish were on offer. In one corner of the larger, western half of the market, there were several stands that offered exotic wares like snake, fox and salamander meat along with scorpions, crocodiles, live hedgehogs (for the equivalent of 4.50 euros per kilogram), living wolf pups (3 euros) and civets (32 euros). Civets are thought to be the transmitter of the SARS coronavirus that began spreading in southern China in 2002.
In such markets, animals are crammed into cages in horrific conditions, and images taken from this part of the market in Wuhan before it was shuttered on Jan. 1 show dismal-looking stands with dire hygienic conditions. Even today, more than four months later, you can still smell the rotten stench if you approach the site, which has been completely cordoned off.
"They allegedly also sold pangolins there," says Chen Qingbo. "But I never saw them. I never went over to those stands. I find wild animals to be dirty and I'm afraid of them." The eastern part of the market, by contrast, was a completely normal Chinese market, says Qingbo. "Even the restrooms were OK. They were cleaned every day."
After he was taken to the Central Hospital, Chen's condition worsened quickly. He was hardly able to stand on his own and his temperature climbed to 39.8 degrees Celsius (103.6 degrees Fahrenheit). He grew panicky when the doctor showed him the CT scan of his lungs. "He told me he had never seen such bad pneumonia. Three quarters of my lungs were completely white in the scan." On Dec. 30, Chen lost consciousness. The doctors took a sample of the fluid in his lungs and told his family that he was in critical condition.
At this point, they had just an initial idea of what kind of virus they could be facing. Several days earlier, the Wuhan Central Hospital had sent a sample from a patient suffering from similar symptoms to Vision Medicals, a genetic laboratory in Guangzhou, and on Dec. 27, the lab had got back to them with the results. "They just called and told us that it was a new type of coronavirus," a head physician from the hospital told the magazine Caixin, adding that he was surprised they hadn't sent a written report.
Because most of those infected with SARS-CoV-2 experience mild symptoms or none at all, scientists now believe that the virus had already spread widely by this point - in Wuhan and likely beyond. Several months later, French doctors went back and tested old samples from patients who had reported flu-like symptoms and found that a man near Paris had become infected with the novel coronavirus as early as Dec. 27.
"I think that the more people look, the more such early cases will be found," says Thomas Briese, a professor of epidemiology at Columbia University Medical Center in New York. A group of British and French scientists did something similar, combing through an online database on the search for tiny differences in genome sequences in thousands of SARS-CoV-2 samples from around the world. In the journal Infection, Genetics and Evolution, they write: "The genomic diversity of the global SARS-CoV-2 population being recapitulated in multiple countries points to extensive worldwide transmission of COVID-19, likely from extremely early on in the pandemic."
"It seems unlikely to me that a global spread could have been prevented," says Grard Krause, head of epidemiology at Germany's Helmholtz Center for Infection Research. Nevertheless, says Torsten Feldt, infectiologist and chief physician at the University Hospital of Dsseldorf, "I am quite certain that many lives would have been saved by an earlier lockdown."
On the afternoon of Dec. 30, Ai Fen, head of emergency services at the Wuhan Central Hospital, received the test results of yet another patient. The test had been performed by a laboratory in Beijing called CapitalBio and the doctor found the results deeply unsettling. The finding: "SARS-coronavirus."
SARS first appeared out of the blue in the early 2000s, an unknown infectious disease with the potential to trigger a pandemic. That illness killed just 774 people before it was then stopped, essentially a warning shot to the world. Was it now back?
"I was so scared I broke out in a cold sweat," Ai later described her reaction on reading the lab report. She informed the clinic leadership, marking the words "SARS-coronavirus" on the report with a red pen, took a photo and sent it along with a patient's CT scan to former medical school classmates and to colleagues in her ward "to remind everybody to be careful."
Ai's message also reached her colleague Li Wenliang, who worked as an ophthalmologist on the third floor of the Central Hospital. At 5:43 p.m., he used WeChat to inform university friends of a presumed SARS outbreak. An hour later, he amended his message due to the apparent preliminary nature of the results from the Beijing laboratory: "It has been confirmed that it is a coronavirus infection, but the precise subtype of the virus is still being evaluated."
As it would turn out, the new pathogen is similar to the SARS coronavirus -- it's not quite as deadly, but it's apparently even more contagious. And the doctors Ai and Li were right to issue warnings, as events would soon show.
On the morning of Dec. 31, officials in white protective suits began disinfecting the Huanan market. Meanwhile, the health agency issued its first public statement on the new illness: In Wuhan, it said, 27 cases of "pneumonia of unknown causes" had appeared. Thus far, the statement continued, there were no confirmed cases of human-to-human transmission.
That last piece of information was reassuring to doctors, researchers and health policy officials around the world. And it seemed perfectly plausible: New viruses generally tend to spread slowly early on.
But despite its plausibility, the information was incorrect. SARS-CoV-2 was an exception. It could be that there were no confirmed cases of human-to-human transmission in late December, but the findings by doctors leave no doubt that such transmissions had long since begun.
Fully 21 days would pass, however, before the Chinese government publicly admitted as much three weeks that contributed immensely to a local epidemic rapidly growing into a worldwide pandemic.
Dr. Ai Fen: "I was so scared, I broke out in a cold sweat."
Shi Zhengli is the most accomplished scientist at the Wuhan Institute of Virology. She was at a conference in Shanghai when she received an urgent phone call from Wuhan telling her to drop everything she was doing. Samples had arrived, she was told, from seven patients exhibiting SARS-like symptoms.
Shi is an internationally recognized virologist who has been nicknamed "Bat Woman" by her colleagues for the virus research she has performed on the animals. She was the one who first identified the viruses that SARS derived from and she has published numerous papers in well-respected journals. In the PubMed database, she is listed with 66 papers published about coronaviruses.
Her team spent the next several days feverishly sequencing the genetic code of the new virus, but Shi herself concentrated on trying to find out whether the new virus matched one of the viral strains on which her institute had been conducting research in recent years. She was initially concerned that an accident may have occurred and a sample may have escaped her laboratory.
The Wuhan Institute of Virology, where she works, is a sprawling complex surrounded by a high electric fence in the southern part of the city. Five years ago, it became the first research site in China with the highest biosafety level BSL-4.
But it wasn't the only state laboratory where Chinese researchers were working hard to sequence the virus. Lan Ke, director of the State Key Laboratory of Virology at Wuhan University, received samples on Jan. 2 containing lung secretions from two patients from Zhongnan Hospital for analysis. "Honestly, my first though was that it could be a new pathogen to be identified," he told DER SPIEGEL. "But we were not sure if it was SARS." By Jan. 3, he and his team had detected the first RNA fragment of the pathogen. They then decoded the sequence and compared it with known viruses using an online database. They found no matches. The scientists furthermore recognized that the pathogen was less similar to SARS than it was to bat-born coronaviruses.
On Jan. 11, the Shanghai Public Health Clinical Center became the first to publish the genome sequence of the pathogen, doing so on the research website virological.org. The sequence came from a sample taken from the fish monger Chen Qingbo.
The next day, the center was temporarily closed down by Chinese authorities. No reason was given for the move.
On Dec. 31, Chen Qingbo was transferred from the Central Hospital of Wuhan to the Jinyintan Hospital, the first of the city's large hospitals to be dedicated specifically to treating patients suffering from the novel coronavirus. The fish seller initially ended up in the intensive care ward, but he was unaware of what was happening to him. He also still didn't know - though it is likely whether he was among the 41 patients chosen by specialists in the hospital to be part of a study that would be published three weeks later in the respected medical journal The Lancet. Even today, it remains one of the most important clinical studies on the early phase of the crisis.
Once his condition began improving and he was transferred to a different ward, Chen started receiving visits from "people from health services or some provincial agency." He says they would show him their IDs and ask him questions. "I don't know anymore who they were or what they wanted," he says. "I could only see their eyes behind thick protective goggles."
Chen has precise memories, though, of the mayor of Wuhan visiting his ward on Jan. 6. "After he left, the nurses told us that the government would be paying for our treatment from then on. And shortly thereafter, all of our costs were reimbursed."
On Jan. 3, Wuhan health officials reported 44 patients with unidentified viral lung infections, including 11 serious cases such as the one experienced by Chen Qingbo. But the number did not reflect the true expanse of the crisis. Many increasingly frustrated doctors were having difficulties reporting the number of new infections to the authorities.
Patients waiting to be transfered to another hospital in Wuhan: The city also provided the blueprint for combating the pandemic.
That system for reporting infections is the key element in what are actually strict regulations in China designed to track outbreaks of contagious diseases. The system was introduced following the SARS crisis and requires clinics to report suspicious cases to the government in Beijing without delay. The system is "quite simple," a doctor told the magazine Caixin. "Prior to corona, when we discovered a case of hepatitis B or another serious infectious disease, we were able to enter our diagnoses directly. A report card would open up, which we would fill out and then click "OK" to upload it."
It was this system that provided Beijing with a timely warning in 2013 of the bird flu outbreak and, in November 2019, of two pneumonic plague cases in Inner Mongolia. But in Wuhan, it suddenly stopped working. The authorities began demanding that hospitals first clarify each new case with the local authorities before they were allowed to upload them into the national reporting system.
In early January, scientists at several genetic laboratories received calls from provincial health authorities from the province of Hubei. They were asked to stop work on the analyses they were currently performing and to destroy their samples. They were then told: "If you perform tests in the future, be sure to report to us," one of the scientists later told Caixin.
As early as Dec. 29, the Central Hospital of Wuhan had sent four reports of corona cases to the local health office for appraisal. The head of the office promised to report back soon, adding that similar case reports had been received from other clinics. Two days later, the doctors asked about the results, but were told to be patient. On Jan. 3, they asked if they should post the case reports - seven of them by then to the national reporting system. They were asked to wait.
The most important political events of the year, after all, were imminent. On Jan. 6, a session of the city parliament was set to begin, and the Peoples Congress for the Hubei province was to convene on Jan. 11. And it was now that the provincial government also issued an order that entries into the national disease tracking system be made "cautiously. Entries were to be coordinated not just with the local health authorities, but also with the city and provincial governments.
The authorities were doing all they could to keep both the public and the central government in the dark about the true extent of the epidemic likely to prevent the disruption of the two parliamentary sessions. It could, however, also have been because they simply didn't want to spread bad news especially not to Beijing.
The loudest voices, the doctors Ai Fen and Li Wenliang, had already been silenced by then. On Jan. 2, Ai was given an "unprecedented, extremely harsh reprimand, as she would later say in a magazine interview. Then, on Jan. 3, the police interrogated Li and he was forced to pledge in writing that he would cease spreading "rumors. He returned to the hospital and contracted the virus himself on Jan. 8.
But even as the authorities sought to downplay the crisis, an increasing number of people infected with the virus began turning up at Wuhan hospitals. The citys health authority reported only 59 cases on Jan. 5, and on Jan. 11, it even spoke of "41 initially diagnosed cases. It claimed that there had been "no new cases since Jan. 3. Against all evidence, the authority also stated that there was no indication that the pathogen, which was now being referred to as the "novel coronavirus, was transmissible from human to human.
But the bad news reached Beijing, anyway, despite the lies from the local authorities. Virologist Gao Fu, the head of Chinas Center for Disease Control and Prevention, has made a habit of scanning China's internet before bedtime for indications of possible disease outbreaks. On Dec. 30, Gao came across rumors about an internal memo from the Wuhan Health Commission on the outbreak of an undefined lung disease. He called an official at the authority and was exasperated by the evasive answers he was given.
The next morning, Gao sent the first of three teams of experts to Wuhan. The Beijing office of the World Health Organization was also officially informed that same day. Shortly afterward, Gao spoke by phone with Robert Redfield, the director of the Centers for Disease Control in the United States, who was on vacation at the time. Redfield was deeply disturbed about what Gao had to report. According to a report in the New York Times, Gao even broke into tears during a later conversation with Redfield.
Meanwhile, officials in Wuhan continued to play down the situation to their colleagues in Beijing. "They said the course of the disease was mild, not much different from seasonal flu, says a member of the second Beijing delegation, which would arrive in Wuhan about a week later.
The local authorities even issued an order that the only patients that should be counted were those who had themselves been to the Huanan market or had a connection with a visitor to the market. As a result of that order, the growing number of infections simply vanished from the statistics. An increasing number of infections, after all, had no connection with the market whatsoever.
Still, even though Beijing was now aware of the situation, official reporting did not change.
The city of Wuhan on Feb. 3: The largest quarantine ever imposed in the history of humankind.
And the Wuhan health authority continued to lie: On Jan. 11, it reported that there hadn't been a single known case among medical staff. In chatrooms, though, the opposite claim was spreading, something that epidemiologist Li Lanjuan learned on Jan. 17. Alarmed, she reported to the National Health Commission and requested permission to drive to Wuhan immediately. Officials in Beijing agreed. On Jan. 18, Li left for the city together with five other epidemiologists. It was only after this visit by the third Beijing delegation that the world would find out what was happening in Wuhan.
The team visited several hospitals, the Huanan market and the Center for Disease Control located only 300 meters away. The experts no longer had any doubts about human-to-human transmission of the virus or that medical personnel had themselves become infected. In a confidential meeting, Li urged that the highest disease alert level - normally reserved for plague or cholera outbreaks be declared. She proposed sealing off the city of Wuhan. There were only a few days left until the peak of the New Year travel season, and the concern was that the disease could spread throughout the country.
The experts flew back to Beijing on Jan. 19 armed with these recommendations. At around midnight, they were received by the Chinese health minister, and the next morning, they attended a cabinet meeting in Zhongnanhai, the innermost circle of power in the Chinese leadership. They issued their warnings at the meeting.
It was then, on Monday, Jan. 20, that the Chinese and the rest of the world would learn of the shocking news from Chinese media. Three days later, in the early morning hours of Jan. 23, Beijing moved to seal Wuhan off from the outside world. In the following days, the lockdown would be extended to include the entire Hubei province. Around 60 million people were ordered to shelter in place in their homes in the largest quarantine ever imposed in the history of humankind.
On the morning of Jan. 23, Wuhan was smothered in a thick layer of smog, with particulate matter levels at six times the legal limit. But there were very few cars on the streets and the few people who did attempt to leave the city were turned back. A convoy of police buses arrived at the airport and by 10 a.m., it was no longer possible to leave the city by air either.
There were also long lines of people in front of hospitals, while emergency rooms had become places of panic and desperation. Ai Fen reported that more than 1,500 patients were now crowding into her department each day, "three times the usual maximum. More than 200 of the 4,000 employees at the Wuhan Central Hospital got infected with the virus at the peak of the epidemic.
Ophthalmologist Li Wenliang was so ill by the end of January that he had to be transferred to the intensive care unit and intubated. On Jan. 27, he defied the official ban on speaking to the press and gave an interview to the state-run Beijing Youth Daily using a messaging app. He could no longer speak. On Feb. 5 and 6, his condition deteriorated further and he had to be placed on life support. The hospital reported on his treatment using the microblogging platform Weibo. Some 17 million users followed the increasingly hopeless developments late into the night.
Shortly before 3 a.m., the doctors lost the battle to save their colleagues life. It unleashed an overwhelming wave of sympathy, with 870,000 users expressing their anger and grief on the internet, leading the state to ultimately abandon its censorship efforts. Li, 33, who left behind a son and a pregnant wife, embodied the center of Chinese society, precisely that segment on which the party bases its rule: the young, hard-working and well-educated. Like many doctors, he had been a member of the Communist Party.
The death of Li Wenliang, who had seen the danger coming, had warned his friends and colleagues and was punished for his efforts, shook many young Chinese so deeply that for a few days it appeared as though the party might lose its hold on society. In some ways, it was evocative of 31 years before, when the death of Hu Yaobang, a politician also revered by many young Chinese and humiliated by the party, triggered the protests in Tiananmen Square.
This time, though, there were no protests. Mourners laid flowers and candles in front of the Central Hospital. The party hastened to announce that it had expressed its condolences to Lis family and it initiated an investigation on the day of his death into the events surrounding his interrogation. A few days later, the government declared Li and 13 other doctors who had died of COVID-19 as "martyrs.
By now, the state and the party were now moving to mobilize all available resources. In the northwest and far south of the city of Wuhan, the Peoples Liberation Army set about constructing two emergency hospitals with more than 2,500 beds, finishing the job within two weeks. Stadiums and convention centers were also converted into makeshift hospitals, and within days, block after block of apartment buildings had been cordoned off, with party members standing guard to make sure people didnt leave their homes.
Virologist Gao Fu: Exasperated by the evasive answers he was given.
The world watched in a daze as Chinas leaders submitted millions of people to its quarantine regime. DER SPIEGEL and other Western media wrote that a lockdown that strict was "unthinkable in a democratic society. At that point, few had any idea that the events in Wuhan were providing a glimpse into their own future - and that only a few weeks later, a significant segment of the global population would find itself stuck in a similar situation. Far from just being the breeding ground for the virus, Wuhan also provided a blueprint for fighting the epidemic.
Eleven weeks after the lockdown was imposed on Wuhan, Wang Xinghuan, the director of one of the largest hospitals in the city, was standing outside his clinic in a tracksuit and speaking of the lessons he had learned from the crisis. "Three things are essential," he said, "rigorous testing, the immediate isolation of suspected cases and the wearing of masks." He said that he was in regular contact with colleagues in New York and that one of them had told him that the wearing of masks was unfortunately a cultural issue. "But it isn't a cultural issue," Wang insisted. "It's stupid to not wear a mask."
In March, an international team of epidemiologists calculated that the number of infections would have been three-times, seven-times or 18-times higher respectively if China had imposed the lockdown on Wuhan one, two or three weeks later than it did. It is difficult to imagine how many cases and deaths there might be in the world today had the country waited.
But the same study estimates that the numbers would have been 66 percent, 86 percent or 95 percent lower respectively had the government closed off the city one, two or three weeks earlier than it did.
Depending on one's perspective, then, Beijing is to be commended for protecting the world from a much greater catastrophe - or is to be condemned for triggering the disaster we are currently experiencing in the first place.
In February, the regime began pushing the first of the two narratives. Chinese President Xi Jinping has even claimed that he personally issued "specifications for the prevention and control of the novel coronavirus" way back on Jan. 7 in a speech before the Politburo Standing Committee. The text of that speech has not been released to the public, but anonymous sources have said that Xi merely decreed that the measures should not detract from the "festive atmosphere" ahead of the Chinese New Year.
The question regarding when Xi learned of the new virus is crucial when it comes to assigning responsibility. There are a number of indications that Beijing was misled by the provincial government and that the central government only recognized the severity of the epidemic in mid-January. But if Xi really was aware of the problem on Jan. 7, then he would have to bear responsibility for the fact that the world was deceived for so long regarding the true nature of the disease.
Wuhan's new top Communist Party official - his predecessor was fired in February proposed in early March that the people of the city undergo "gratitude education." The party went on to publish a book called "2020: A Battle Against the Epidemic," which honors Xi's alleged accomplishments in the "people's war" against the virus. Following a wave of indignation in the Chinese internet, though, the campaign was soon suspended.
The government, however, can now point to foreign sources to prop up its version of events. WHO head Tedros Adhanom Ghebreyesus said he had been "impressed and encouraged by the president's detailed knowledge of the outbreak" following a visit he made to Beijing in late January. Quotes such as this one are quite helpful to Beijing, both for its domestic propaganda and for its international PR campaign, which seems to be growing in strength by the week.
In this battle over the coronavirus narrative, Chinese diplomats eagerly cite statements and tweets from U.S. President Donald Trump. Quotes like this tweet from Jan. 24: "China has been working very hard to contain the Coronavirus. () I want to thank President Xi!" Or this remark from Feb. 7: "I just spoke to President Xi last night. () I think he's handled it really well."
In the meantime, of course, Trump has begun disputing the numbers that he was praising just 10 weeks ago and is now accusing China of lying and he's not the only one. He has also begun claiming that he has intelligence information whereby the virus actually escaped from a Chinese laboratory, a reference to the Wuhan Institute of Virology in the southern part of the city the lab where "Bat Woman" Shi Zhengli works.
People pay respect at a memorial to Dr. Li Wenliang: "There should be more than one voice in a healthy society."
In February, Shi told the U.S. magazine Scientific American that she worked day and night at the beginning of the epidemic comparing all the samples the institute had ever used for research with the genome sequence of SARS-CoV-2 - and found no matches. "That really took a load off my mind," she told the magazine. She believes her lab bears no responsibility for the outbreak.
In mid-April, only a few cars could be seen on the other side of the electric fence in the parking lot of the Wuhan Institute of Virology. Visitors are not welcome. A car drove up and a young man in street clothes introduced himself as Mr. Zhao from "Bio Security." He demanded to know what the reporter was looking for. An interview with Dr. Shi, perhaps? "Impossible," was the response. But wouldn't it be helpful to respond to the rumors that are spreading around the world? Mr. Zhao smiled. "It doesn't matter what we say. These theories will spread regardless."
Some of those theories are rather preposterous. Nobel prize laureate Luc Montagnier, who was one of the scientists to discover the virus that causes AIDS, claimed on French television that SARS-CoV-2 was produced in the lab and contains genome sequences from the HIV virus. Researchers were quick to contradict him: "Montagnier failed to find that both fragments are actually also commonly found in many other viruses, including coronaviruses from bats and pigeons," the team of Yang Zhang, professor of computational medicine and bioinformatics at the University of Michigan, told DER SPIEGEL.
The most likely scenario is that the two genome fragments ended up in SARS-CoV-2 as the result of a completely natural process. That, at least, is what the vast majority of leading virologists believe.
It is, of course, possible that an employee of the Wuhan Institute of Virology may have become infected with an unknown, natural bat virus despite wearing protective clothing, but it is "extraordinarily unlikely," says Robert Garry of the Tulane University School of Medicine.
U.S. intelligence likewise issued a statement saying that the broad consensus is that the virus is not manmade. China has thus far refused to permit an international investigation into the origins of the virus. But without such a study, rumors will continue to spread regarding the beginning and development of the disease.
A particularly absurd conspiracy, which ironically originated in the U.S., has been spreading in Wuhan itself. The fish seller Chen Qingbo says that "many of my friends believe, as do I, that the virus was brought to Wuhan during the Military World Games last fall. The U.S. athletes apparently stayed in a hotel not far from the Huanan market and some of them allegedly were suffering from a similar illness." He then asks: "Couldn't that be true?"
Following his recovery, Chen was released from the hospital on Jan. 11, well before the epidemic reached its peak. After finishing his quarantine, he received a text message from the hospital's chief physician: "Recovered patients are kindly requested to donate blood plasma for scientific purposes." Chen responded immediately and has been to the hospital five times since then. He has resumed working, but he now supplies fruit and vegetables instead of fish. And he now works out of a different market.
Ai Fen is still the head of emergency services at the Central Hospital of Wuhan. On March 10, she gave a long interview to China's state-run People magazine in which she said: "I regret that back then I didn't keep screaming out at the top of my voice. I've often thought to myself what would have happened if I could wind back time."
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A Failed Deception: The Early Days of the Coronavirus Outbreak in Wuhan - DER SPIEGEL
Androgen Replacement Therapy Market 2020 Coronavirus (Covid-19) Business Impact Future Forecast Assessed On The Basis Of How The Market Is Predicted…
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Androgen replacement therapy (ART), often referred to as testosterone replacement therapy (TRT), is a form of hormone therapy, in which androgens, often testosterone, are replaced. ART is often prescribed to counter the effects of male hypogonadism. It typically involves the administration of testosterone through injections, skin creams, patches, gels, or subcutaneous pellets. Testosterone replacement therapy is a promising technology for improving symptoms of hypogonadism and to raise the testosterone level. Furthermore, benefits related to application of testosterone replacement therapy include an increase in muscle tissue, overall surge in energy, and significant decrease in depression symptoms.
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Top Manufacturers in GlobalAndrogen Replacement TherapyMarket Includes:AbbVie, Inc., Allergan Plc, Bayer AG, Endo Pharmaceuticals, Inc., Eli Lilly and Company, Kyowa Kirin International Plc, Mylan N.V., Novartis International AG, Pfizer, Inc., Clarus Therapeutics, Ferring Holding SA, Perrigo Company Plc, Acerus Pharmaceuticals Corporation, Upsher-Smith Laboratories, LLC, Dr. Reddys Laboratories, Bausch Health Companies Inc., Sun Pharmaceutical Industries Ltd., and Par Pharmaceutical.
Regions & Countries Mentioned In The Androgen Replacement Therapy Market Report:
Key Highlights of the Table of Contents:
Androgen Replacement Therapy Market Study Coverage: It includes key manufacturers covered, key market segments, the scope of products offered in the global market, years considered, and study objectives. Furthermore, it tuches the segmentation study provided in the report on the basis of the type of product and applications.
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An Overview of the Impact of COVID-19 on this Market:
The pandemic of COVID-19 continues to expand and impact over 175 countries and territories. Although the outbreak appears to have slowed in China, COVID-19 has impacted globally. The pandemic could affect three main aspects of the global economy: production, supply chain, and firms and financial markets. National governments have announced largely uncoordinated, country-specific responses to the virus. As authorities encourage social distancing and consumers stay indoors, several businesses are hit. However, coherent, coordinated, and credible policy responses are expected to offer the best chance at limiting the economic fallout.
National governments and international bodies are focused on adopting collaborative efforts to encourage financial institutions to meet the financial needs of customers and members affected by the coronavirus. However, there are some sectors that have remained unscathed from the impact of the pandemic and there are some that are hit the hardest.
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Prevent Blindness Offers New Educational Resources on IRD’s, Importance of Genetic Testing and Services – InvisionMag
(PRESS RELEASE) CHICAGO In order to help patients with Inherited Retinal Diseases (IRDs) receive an accurate diagnosis through genetic testing, Prevent Blindness, the nations oldest volunteer eye health organization, is embarking on a new awareness initiative to educate the public on IRDs, a group of genetic disorders that can cause severe vision loss or total blindness. A recent editorial noted that IRDs are the leading cause of vision loss in persons between 15 and 45 years of age- impacting one in every 2,000 people.
To continue the Prevent Blindness mission of preventing blindness and saving sight, the group has declared May 17-23, 2020 as Inherited Retinal Disease Genetic Testing Week. As part of this initiative, Prevent Blindness has created a dedicated webpage (to go live on May 15, 2020) with no-cost educational resources on IRDs, providing detailed information on risk factors, therapy and research options, financial assistance services, the importance of genetic testing, and more. Shareable social media graphics on IRDs are also available. Development of these new resources was supported by a donation from Spark Therapeutics, a gene therapy company striving to challenge the inevitability of genetic disease.
The most common types of IRDs include:
All those diagnosed with IRDs should work with their healthcare professional to develop a disease management plan tailored to the patients needs.
Patients with suspected IRDs are encouraged to participate in genetic testing, even those who were tested more than five years ago and did not receive a definitive result. According to the National Institutes of Health, genetic testing is a type of medical test that identifies changes in chromosomes, genes, or proteins. The results of a genetic test may provide a detailed diagnosis which confirms or rules out most suspected genetic conditions and the test can help determine a persons chance of developing or passing on a genetic disorder to their children. Free genetic testing is now available from select organizations and commercial businesses, including through the ID YOUR IRD program.
Inherited retinal diseases can have a significant impact on the quality of life for patients, including affecting the ability to work and live independently, said Jeff Todd, president and CEO of Prevent Blindness. Fortunately, today there are more therapies being researched than ever before. We encourage patients and their caregivers to educate themselves on steps that can be taken today to save sight for tomorrow.
As a leading gene therapy company with a strong commitment to genetic testing for the IRD community, Spark Therapeutics is pleased to support the Prevent Blindness inaugural IRD Genetic Testing Week, said Dan Chung, DO, MA, ophthalmology therapeutic area leader, Spark Therapeutics. We encourage patients living with IRDs and caregivers to pursue genetic testing in order to receive a true, genetic diagnosis.
For more information on IRDs and genetic testing for vision issues, please call Prevent Blindness at (800) 331-2020 or visit here. For a listing of vision care financial assistance programs in English or Spanish, visit here.
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Prevent Blindness Offers New Educational Resources on IRD's, Importance of Genetic Testing and Services - InvisionMag
COVID-19 Impact on GENETIC TESTING SERVICES MARKET INSIGHT ON THE ANALYSIS BY ESSENTIAL FACTORS AND TRENDS IN INDUSTRY BY 2027 – Cole of Duty
The Covid-19 (coronavirus) pandemic is impacting society and the overall economy across the world. The impact of this pandemic is growing day by day as well as affecting the supply chain. The COVID-19 crisis is creating uncertainty in the stock market, massive slowing of supply chain, falling business confidence, and increasing panic among the customer segments. The overall effect of the pandemic is impacting the production process of several industries including Life science Industry, and many more. Trade barriers are further restraining the demand- supply outlook. As government of different regions have already announced total lockdown and temporarily shutdown of industries, the overall production process being adversely affected; thus, hinder the overall Genetic Testing Service market globally. This report on Genetic Testing Service market provides the analysis on impact on Covid-19 on various business segments and country markets. The report also showcase market trends and forecast to 2027, factoring the impact of Covid -19 Situation.
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The Genetic Testing Service market was valued at US$ 9,546.2 million in 2019 and is expected to grow at a CAGR of 11.7% from 2020 to 2027 to reach US$22,701.8million by 2027.
Market Insights
Government initiatives to increase awareness in the European Region
In Europe, Genetic testing has been growing at an exceptional rate; a large panel of tests are now offered to screen a number of genetic diseases. Treatments are available for a number of rare genetic diseases, and the process is gaining importance in scenarios, such as carrier testing, newborn screening, predictive, and pre-symptomatic testing, among others. Moreover, European countries have undertaken a number of initiatives to increase awareness among people about the benefits of genetic testing. For instance, EuroGentest is a project funded by the European Commission to harmonize the process of genetic testing, from sampling to counseling, across Europe. The ultimate goal is to ensure that all aspects of genetic testing are of high quality, thereby providing accurate and reliable results for the benefit of the patients. In addition, the UK Genetic Testing Network (UKGTN), an advisory organization in UK, promotes equity of access to genetic testing and provides contracting support to the NHS
Type Insights
The global genetic testing service market, based on the type, has been segmented into predictive testing, carrier testing, prenatal testing, newborn screening and others. In 2019, the predictive testing segment accounted for the largest market share in the global genetic testing service market by disease. Genetic Testing Services consist of large panel of tests are now offered to screen a number of genetic diseases. Treatments are available for a number of rare genetic diseases, and the process is gaining importance in scenarios, such as carrier testing, newborn screening, predictive, and pre-symptomatic testing, among others.
Key Players
The research provides answers to the following key questions:
The study conducts SWOT analysis to evaluate strengths and weaknesses of the key players in the Genetic Testing Services market. Further, the report conducts an intricate examination of drivers and restraints operating in the market. The report also evaluates the trends observed in the parent market, along with the macro-economic indicators, prevailing factors, and market appeal according to different segments. The report also predicts the influence of different industry aspects on the Genetic Testing Services market segments and regions.
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Genetic Testing Services Market Segmented by Region/Country: North America, Europe, Asia Pacific, Middle East & Africa, and Central & South America
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Genetic Testing Market Report 2020: Acute Analysis of Global Demand and Supply 2025 with Major Key Player: GeneDx, Invitae, Pathway Genomics, Counsyl…
Due to the pandemic, we have included a special section on the Impact of COVID 19 on the Genetic TestingMarket which would mention How the Covid-19 is Affecting the Industry, Market Trends and Potential Opportunities in the COVID-19 Landscape, Key Regions and Proposal for Genetic Testing Market Players to battle Covid-19 Impact.
The Genetic TestingMarket report is one of the most comprehensive and important data about business strategies, qualitative and quantitative analysis of Global Market. It offers detailed research and analysis of key aspects of the Genetic Testing market. The market analysts authoring this report have provided in-depth information on leading growth drivers, restraints, challenges, trends, and opportunities to offer a complete analysis of the Genetic Testing market.
Top Leading players covered in the Genetic Testing market report: GeneDx, Invitae, Pathway Genomics, Counsyl Inc, Asper Biotech, GenePlanet, Courtagen Life Sciences, Gene By Gene, Natera Inc, Regulatory, GeneTests, United Gene, HI Gene, Berry Genomics, 23andMe Inc, 360Jiyin, Novogene, CapitalBio, Agen, Biomedlab, Biomarker, Annoroad, Aiyin Gene, Aijiyin, Repconex, Find Bio-Tech, SinoGenoMax, Gene Kang, Geeppine, BGI and More
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The report offers clear guidelines for players to cement a position of strength in the global Genetic Testing market. It prepares them to face future challenges and take advantage of lucrative opportunities by providing a broad analysis of market conditions. the global Genetic Testing market will showcase a steadyCAGR in the forecast year 2020 to 2025.
Based on products type, the report describes major products type share of regional market. Products mentioned as follows:Newborn ScreeningDiagnostic TestingCarrier TestingPreimplantation Genetic DiagnosisPrenatal DiagnosisPredictive and Presymptomatic TestingPharmacogenomicsBased on Application, the report describes major application share of regional market. Application mentioned as follows:CardiologyDermatologyHematologyHereditary CancerImmunologyMetabolic Disorders and Newborn ScreeningNeurologyOphthalmologyPediatric GeneticsOthers
Our Complimentary Sample Genetic Testing market Report Accommodate a Brief Introduction of the research report, TOC, List of Tables and Figures, Competitive Landscape and Geographic Segmentation, Innovation and Future Developments Based on Research Methodology.
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Regions Covered in the Global Genetic Testing Market: The Middle East and Africa (GCC Countries and Egypt) North America (the United States, Mexico, and Canada) South America (Brazil etc.) Europe (Turkey, Germany, Russia UK, Italy, France, etc.) Asia-Pacific (Vietnam, China, Malaysia, Japan, Philippines, Korea, Thailand, India, Indonesia, and Australia)
Years Considered to Estimate the Genetic Testing Market Size:History Year: 2015-2019Base Year: 2019Estimated Year: 2020Forecast Year: 2020-2025
Highlights of the Report: Accurate market size and CAGR forecasts for the period 2019-2025 Identification and in-depth assessment of growth opportunities in key segments and regions Detailed company profiling of top players of the global Genetic Testing market Exhaustive research on innovation and other trends of the global Genetic Testing market Reliable industry value chain and supply chain analysis Comprehensive analysis of important growth drivers, restraints, challenges, and growth prospects
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Genetic Testing Market Report 2020: Acute Analysis of Global Demand and Supply 2025 with Major Key Player: GeneDx, Invitae, Pathway Genomics, Counsyl...
Burning Rock deepens cooperation with Illumina to promote development and standardization of NGS-based cancer therapy selection in China – BioSpace
SHANGHAI, China, May 10, 2020 (GLOBE NEWSWIRE) -- Burning Rock and Illumina (NASDAQ: ILMN), a global leader in gene sequencing and array-based technologies, jointly announced today that they are joining forces to promote the development and standardization of NGS-based cancer therapy selection in China based on Illuminas NextSeqTM 550Dx system.
In 2015, Illuminas sequencing technology and Burning Rocks development and commercial capabilities were for the first time combined, providing Chinas precision oncology market with advanced NGS-based cancer therapy selection solutions in the past five years. In 2020, as the first genetic testing company in China to achieve development of in vitro diagnostic (IVD) tests for both circulating tumor DNA (ctDNA) and tissue based on the NextSeqTM 550Dx system agreement with Illumina, Burning Rock will further expand and deepen the application of NGS technologies in the field of cancer therapy selection.
The value of NGS application in precision medicine and companion diagnostics has been widely recognized by clinical experts and cancer patients. Compared with traditional genetic testing methods, NGS-based cancer therapy selection allows patients to understand the mutation of multiple genes related to cancer treatment, providing doctors and patients with one-stop targeted therapy and immunotherapy drugs testing solutions, ultimately saving time and preserving samples.
In July 2018, Burning Rocks innovative product "Human EGFR / ALK / BRAF / KRAS gene mutation detection kit (reversible end termination sequencing method)" based on Illumina sequencing system became the first NGS-based reagent kit to be approved by National Medication Products Administration (NMPA). Since then, tumor NGS testing can be officially used in Chinese hospitals. In the future, Burning Rock will continue to seek NMPA approvals for its IVD products based on NextSeqTM 550Dx and other sequencing systems to promote the implementation of tumor NGS products in hospitals and benefit more cancer patients.
Through our long-term, close and pleasant cooperation with Illumina, we have delivered the world's leading NGS-based therapy selection solutions for clinical oncology, and improved the development and application of NGS-based cancer therapy selection in China. said Mr. Han Yusheng, founder and CEO of Burning Rock. Today we are delighted to announce that Burning Rock and Illumina will further deepen cooperation based on the NextSeqTM 550Dx system, to provide more high-quality molecular diagnostic solutions for clinical oncology treatment and promote the standardization of NGS-based cancer therapy selection in China.
Burning Rock is one of the leading precision oncology companies in China, said Joydeep Goswami, Senior Vice President of Corporate Development and Strategic Planning at Illumina, said. I am pleased to see that during the close cooperation with Illumina in the past five years, Burning Rock has continuously developed tumor diagnosis solutions that meet the needs of the local market. The new agreement is a testament to our strong cooperation in the past, and also the beginning of a more in-depth cooperation.
Li Qing, General Manager of Greater China at Illumina, said: Burning Rock has brought hope to countless Chinese patients by providing a series of tumor molecular diagnostic solutions. And we are very happy to be involved. In the future, I firmly believe that genetic testing technology will further change the current treatment paradigm for cancer and provide critical support to conquer this disease at an early date.
About Burning RockBurning Rock, whose mission is to Guard Life via Science, focuses on the application of next generation sequencing (NGS) technology in the field of precision oncology. Its business consists of i) NGS-based therapy selection testing for late-stage cancer patients, with the leading market share in China and over 185,000 tissue and liquid-based tests completed cumulatively, and ii) NGS-based cancer early detection, which has moved beyond proof-of-concept R&D into the clinical validation stage.
About IlluminaIllumina is improving human health by unlocking the power of the genome. Our focus on innovation has established us as the global leader in DNA sequencing and array-based technologies, serving customers in the research, clinical and applied markets. Our products are used for applications in the life sciences, oncology, reproductive health, agriculture and other emerging segments. To learn more, visit http://www.illumina.com and follow @illumina.
Breaking the Code: A lifetime of pain, due to genetic drug intolerance – FirstCoastNews.com WTLV-WJXX
A negative drug test for an decades-long opioid patient reveals a genetic abnormality that might be more common than expected.
JACKSONVILLE, Fla. For Linda Armstrong, the pain started 25 years ago with a truck going 45 miles an hour. It left her with severe neurological and brain injuries.
On a scale of one to 10, she said, There are days when its 10. I mean you literally cant move.
Like millions of Americans, she was prescribed opioids -- Vicodin, Dilaudid, Percocet but the pain persisted.
I would get some relief, but nothing that ever really made me functional, she said, "and it always made me nauseous.
Armstrongs lackluster response to pain medications had been a reality since she was a child. Once, getting a cavity filled, she recalls, I had to have 10 shots for one filling because it just would not numb.
Her resistance to drugs was simply anecdotal until she visited her doctor in October. Under new Centers for Disease Control and Prevention guidelines, doctors test opioid patients both for the presence of illegal drugs, and to ensure they are taking and not selling their pain meds.
Her test? Completely negative. There were no drugs of any type in my system.
Initially, her doctor wrote it off as a fluke.
When it happened a second time, Armstrong explained, her doctor said Linda we have to talk about this.
She took another test this time going so far as to take pills while her doctor watched. She even got her hair tested.
Fortunately, Armstrong has had the same doctor since the mid-'90s, and rather than doubting her, she worked to help get answers. She ordered a genetic test, which revealed significant abnormalities -- including in an enzyme called CYP2d6, which metabolizes opioids.
The test revealed something researchers in the field of pharmacogenomics know, but few patients do. People do not respond to drugs in the same way, explains Standford University researcher Dr. Russ Altman in a Ted Talk. Some people get no pain relief at all.
Armstrongs genetic test showed she was a hyper-metabolizer of opioids an issue that creates problems beyond pain. As Altman says, there are only two things a doctor can think when a patient complains they arent getting relief from opioids.
I could think this person is a CYPD2d6 non-responder, or I could think this is a trouble-making drug-seeker who wants something stronger, Altman said. Most doctors think the latter.
Armstrongs case is dramatic but not unusual. Dr Liewei Wang at Mayo Clinic in Rochester, Minn., is a leading researcher in pharmacogenomics research into the interaction of genes and drugs. She says 99 percent of people have at least one genetic variant that affects drug response. Response is variable, and in some cases not desirable.
Genetic testing can predict who may or may not respond, she said, and for those who dont respond -- are there alternative therapies?
In some cases, the wrong drug can be fatal. Already, hospitals like UF Health test cardiac patients before surgery for a gene that complicates blood clotting.
And some fields, like oncology and psychiatry, routinely use genetic tests to prescribe drugs. But most patients arent aware such tests even exist.
Jacksonville Pharmacist Todd Troxell believes genetic testing is the key to more effective prescribing. When you go get your glasses we dont just say, pick something up and go home. We get your prescription, he says. You cant see out of myglasses.
After looking at Armstrongs test, Troxell was able to steer her to a different pain medication that is working. I could tell from what she had on her report she wasnt going to be able to take certain medications.
Troxell would like to see genetic testing more widely available -- and comprehensible. Companies focused on translating dense genetic code into pharmaceutical recommendations were effectively shut down by the FDA in 2018. The agency worriedthe tests could pose significant public health concerns as inaccurate test results could impact the decision-making of healthcare providers and patients in ways that are seriously detrimental to patient health.
The agency walked that back slightly earlier this year, creating a Table of Pharmacogenetic Associations, which lists gene-drug interactions the agency believes are based on sufficient scientific evidence based on published literature.
For now, a genetic test needs to be ordered by a physician, who may or may not be able to interpret the code. And genetics remains just one element that doctors and patients should consider, including age, weight and environmental factors.
But patients like Armstrong say breaking the genetic code shouldnt be a secret it could literally spare them a lifetime of pain. Given the chance early on, she said, I would have had that test done in a heartbeat.
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Breaking the Code: A lifetime of pain, due to genetic drug intolerance - FirstCoastNews.com WTLV-WJXX
Kevin Hart Lost his Mom, Nancy to Ovarian Cancer Now, He Reveals Baby Girl, As Treatment Advances Bring Hope – SurvivorNet
Losing a parent to cancer is so hard. On Mothers Day, Kevin Hart paid tribute to his mom, Nancy, who died of ovarian cancer in 2007. He also joined his wife, Eniko, and children wearing pink and white to reveal the gender of their upcoming baby a girl. Happy Mothers Day to this beautiful woman & wife of
mine. we are thrilled about the arrival of our baby girl.Family of 6 WOOOOOOOOW!!!! God is unbelievable.We are blessed to have you in our lives, Hart wrote on Instagram. All I can say is thank you honey.
With no screening test for ovarian cancer, its among the more difficult cancers to diagnose early. Symptoms include abdominal bloating or swelling, quickly feeling full while eating, weight loss, pelvic discomfort or pain, constipation, or a frequent need to urinate but theyre so non-specific that the disease often goes undetected.
RELATED:Exciting Developments in Immunotherapy for Ovarian Cancer
But treatment advances, including genetic testing, minimally invasive surgical techniques, and PARP inhibitor drug therapies have improved the outlook for patients diagnosed today, compared to 2007, when Nancy Hart was fighting the disease over a decade ago.
Experts urge women diagnosed with ovarian cancer, to seek genetic testing at the time of diagnosis, not recurrence. A recent study found that too few women are being tested for mutations of the BRCA gene, like BRCA1 or BRCA2. The presence of these mutations guides treatment decisions and identifies whether patients and family members at a heightened risk for breast cancer or ovarian cancer.
All women diagnosed with ovarian cancer should undergo genetic testing, says Dr. UrsulaMatulonis, Chief of the Division of Gynecologic Oncology at Dana-Farber Cancer Institute.
Ovarian cancer usually develops in women who are post-menopause. But younger women may also get the disease, especially if they carry the BRCA-1 or BRCA-2 genes.
A woman who inherits the BRCA1 gene has a 44% lifetime risk (by age 80) for developing ovarian or fallopian tube cancer, and 70-80% risk of developing breast cancer. With the BRCA2 gene, the risk for ovarian and fallopian tube cancer is 17% higher, while the breast cancer risk is around 70%
Minimally invasive surgical techniques, including robotic surgery using the da Vinci Robot, can benefit about half of women diagnosed with ovarian cancer. These new approaches allow surgeons to be more precise in pinpointing and removing ovarian cancer, which may have spread to surrounding organs. The smaller incisions also help decrease post-operative pain and speed recovery time for patients.
Dr. Allan James (A.J.) White a gynecologic oncologist at the START Center for Cancer Care in San Antonio, Texas, has seen robotic surgery dramatically change ovarian cancer treatment.
Robotic surgery uses cameras and special robotic surgery tools to make it possible for surgeons to operate through a series of small incisions. For ovarian cancer, doctors make about five incisions, each less than a centimeter in size, around the belly button rather than a large open incision down the abdomen midline.
RELATED: Considerations Before And After Ovarian Cancer Surgery
The robotic surgery presents high costs for the medical system, but Dr. White says its so good for the patientsthat, around the country and really around the world,most of us have been shifting to using the robotic techniquewhen its appropriate. For patients, the higher cost of robotic surgery may be offset by decreased hospital time, as its often possible to go home on the day of surgery or shortly thereafter.
Minimally invasive surgery is most appropriate when the disease is focused in the pelvis. Robotic surgery is not an option for every woman with ovarian cancer, saysDr. Lori Weinberg, gynecologic oncologist with Minnesota Oncology.
RELATED:The Robotic Surgery Option for Ovarian Cancer Patients
Most patients with ovarian cancer have disease that is spread out in multiple places, where the robotic platform just cannot achieve what we can do through an open incision, she explains. We really have to tailor our approach to treatment based on what were seeing from the imaging, and also on a patients physical exam.
PARP inhibitors can be a beneficial treatment option for many women with ovarian cancer. These oral drugs work by preventing ovarian cancer cells from repairing DNA damage, which prevents them from continuing to divide and spread.
Amanda Westwood, a physician assistant at UT Southwestern Medical Center in Dallas, Texas. Westwood describes these different potential options:
Recent research confirms that most women with ovarian cancer can benefit from PARP inhibitors, Amanda Westwood, a physician assistant at UT Southwestern Medical Center in Dallas, Texas,although the timing of that benefit can vary depending on her cancers genetic profile, among other factors.
RELATED:PARP Inhibitors for Ovarian Cancer: Understanding the Options
The PARPs have a huge importance in treating ovarian cancer, whether it be upfront maintenance for our BRCA patients or a recurrence setting if theyve had a partial or complete response, and even down the line they can be used as treatment alone, says Amanda Westwood, a physician assistant at UT Southwestern Medical Center in Dallas, Texas.
Westwood describes these different potential options:
After beginning treatment with PARP inhibitors, most women will go in for frequent tests to monitor their tolerance and make sure that the side effects are managed. While some women may experience nausea, the most common side-effect is fatigue. The drugs may also impact blood counts; another reason for close monitoring with lab work.
RELATED: PARP Inhibitors: A Game Changer in Ovarian Cancer Treatment
Over time, these tests may become less frequent.While some women may experience nausea, the most common side-effect is fatigue. But most of the time, patients tolerate PARP inhibitors fairly well, Westwood says.
PARP inhibitors can have a positive impact on progression-free survival, a term doctors use for living with ovarian cancer for a period of time without seeing it spread or progress.
Learn more about SurvivorNet's rigorous medical review process.
Constance Costas is a writer for SurvivorNet.
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Kevin Hart Lost his Mom, Nancy to Ovarian Cancer Now, He Reveals Baby Girl, As Treatment Advances Bring Hope - SurvivorNet
Preimplantation Genetic Testing Market Size, Share, Analysis, Applications, Sale, Growth Insight, Trends, Leaders, Services and 2025 Forecast – Cole…
A leading research firm, Adroit Market Research added a latest industry report on Global Preimplantation Genetic Testing Market, consisting of 180+ pages during the forecast period and preimplantation genetic testing market report offers a comprehensive research updates and information related to market growth, demand, opportunities in the global preimplantation genetic testing market. The coronavirus epidemic (COVID-19) has affected all aspects of life around the world. This has changed some of the market situation. The main purpose of the research report is to provide users with a broad view of the market. Initial and future assessments of rapidly changing market scenarios and their impact are covered in the report.
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The preimplantation genetic testing market report provides in-depth analysis and insights into developments impacting businesses and enterprises on global and regional level. The report covers the global preimplantation genetic testing market performance in terms of revenue contribution from various segments and includes a detailed analysis of key trends, drivers, restraints, and opportunities influencing revenue growth of the global preimplantation genetic testing market. This report studies the global preimplantation genetic testing market size, industry status and forecast, competition landscape and growth opportunity. This research report categorizes the global preimplantation genetic testing market by companies, region, type and end-use industry.
Top Leading Key Players are:
Thermo Fisher Scientific, Inc., Agilent Technologies, Inc., PerkinElmer, Inc., CooperSurgical, Inc., Beijing Genomics Institute (BGI), Abbott Laboratories, Natera, Inc., Genea Limited, Rubicon Genomics, Inc. and Oxford Gene Technology
Read complete report with TOC at:https://www.adroitmarketresearch.com/industry-reports/preimplantation-genetic-testing-market
The preimplantation genetic testing market report mainly includes the major company profiles with their annual sales & revenue, business strategies, company major products, profits, industry growth parameters, industry contribution on global and regional level. This report covers the global preimplantation genetic testing market performance in terms of value and volume contribution. This section also includes major company analysis of key trends, drivers, restraints, challenges, and opportunities, which are influencing the global preimplantation genetic testing market. Impact analysis of key growth drivers and restraints, based on the weighted average model, is included in this report to better equip clients with crystal clear decision-making insights.
Global Preimplantation Genetic Testing Market is segmented based by type, application and region.
Based on Type, the market has been segmented into:
by Test Type (Aneuploidy, Structural Chromosomal Abnormalities, Single Gene Disorders, X-linked Disorders, HLA Typing, Gender Identification) and Technology (Next Generation Sequencing, Polymerase Chain Reaction, Fluorescent In-Situ Hybridization, Comparative Genomic Hybridization, Single Nucleotide Polymorphism)
The preimplantation genetic testing market research report mainly segmented into types, applications and regions. The market overview section highlights the preimplantation genetic testing market definition, taxonomy, and an overview of the parent market across the globe and region wise. To provide better understanding of the global preimplantation genetic testing market, the report includes in-depth analysis of drivers, restraints, and trends in all major regions namely, Asia Pacific, North America, Europe, Latin America and the Middle East & Africa, which influence the current market scenario and future status of the global preimplantation genetic testing market over the forecast period.
The preimplantation genetic testing market report provides company market size, share analysis in order to give a broader overview of the key players in the market. Additionally, the report also includes key strategic developments of the market including acquisitions & mergers, new product launch, agreements, partnerships, collaborations & joint ventures, research & development, product and regional expansion of major participants involved in the market on the global and regional basis.
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Covid-19 impact on Autologous Stem Cell and Non-Stem Cell Based Therapies Market 2020 Industry Research, Share, Trend, Industry Size, Price, Future…
This Autologous Stem Cell and Non-Stem Cell Based Therapies Market research document predicts the size of the market with information on key vendor revenues, development of the industry by upstream & downstream, industry progress, key companies, along with type segment & market application. This market study takes into account a market attractiveness analysis, where each segment is benchmarked based on its market size, growth rate, and general attractiveness. Another major section of this Autologous Stem Cell and Non-Stem Cell Based Therapies Market report is the competitive landscape which provides a clear insight into the market share analysis and actions of key industry players. Quality and transparency is strictly maintained while carrying out research studies to offer an exceptional market research document for your niche.
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All the data of this market report is exceptionally useful to the clients and businesses for making decisions related to revenue, investment, import, export and consumption. To meet the strategic as well as specific needs of the organization or business, a comprehensive market research document such as this Autologous Stem Cell and Non-Stem Cell Based Therapies Market report, has to be in place. Geographical scope of the products is also carried out comprehensively for the major global areas such as Asia, North America, South America, and Africa which helps define strategies for the product distribution in those areas. Competitive landscape is explored in terms of product range, strategies, and future prospects of the key players of the Healthcare industry.
Market AnalysisBesides target market information, DBMR also provides information about your competitor, your customers, products etc. A few techniques we use are: Customer analysis Competitor analysis Risk analysis Product research Advertising research E-mail survey and many more
TheGlobalAutologous Stem Cell and Non-Stem Cell Based Therapies Marketis expected to reach USD113.04 billion by 2025, from USD 87.59 billion in 2017 growing at a CAGR of 3.7% during the forecast period of 2018 to 2025. The upcoming market report contains data for historic years 2015 & 2016, the base year of calculation is 2017 and the forecast period is 2018 to 2025.
Some of the major players operating in the globalautologous stem cell and non-stem cell based therapies marketareAntria (Cro), Bioheart, Brainstorm Cell Therapeutics, Cytori, Dendreon Corporation, Fibrocell, Genesis Biopharma, Georgia Health Sciences University, Neostem, Opexa Therapeutics, Orgenesis, Regenexx, Regeneus, Tengion, Tigenix, Virxsys and many more.
Browse Detailed TOC Herehttps://www.databridgemarketresearch.com/toc/?dbmr=global-autologous-stem-cell-and-non-stem-cell-based-therapies-market
Market Definition:Global Autologous Stem Cell and Non-Stem Cell Based Therapies Market
In autologous stem-cell transplantation persons own undifferentiated cells or stem cells are collected and transplanted back to the person after intensive therapy. These therapies are performed by means of hematopoietic stem cells, in some of the cases cardiac cells are used to fix the damages caused due to heart attacks. The autologous stem cell and non-stem cell based therapies are used in the treatment of various diseases such as neurodegenerative diseases, cardiovascular diseases, cancer and autoimmune diseases, infectious disease.
According to World Health Organization (WHO), cardiovascular disease (CVD) causes more than half of all deaths across the European Region. The disease leads to death or frequently it is caused by AIDS, tuberculosis and malaria combined in Europe. With the prevalence of cancer and diabetes in all age groups globally the need of steam cell based therapies is increasing, according to article published by the US National Library of Medicine National Institutes of Health, it was reported that around 382 million people had diabetes in 2013 and the number is growing at alarming rate which has increased the need to improve treatment and therapies regarding the diseases.
Market Segmentation:Global Autologous Stem Cell and Non-Stem Cell Based Therapies Market
Competitive Analysis:Global Autologous Stem Cell and Non-Stem Cell Based Therapies Market
The global autologous stem cell and non-stem cell based therapies market is highly fragmented and the major players have used various strategies such as new product launches, expansions, agreements, joint ventures, partnerships, acquisitions, and others to increase their footprints in this market. The report includes market shares of autologous stem cell and non-stem cell based therapies market for global, Europe, North America, Asia Pacific and South America.
Major Autologous Stem Cell and Non-Stem Cell Based Therapies Market Drivers and Restraints:
Introduction of novel autologous stem cell based therapies in regenerative medicine
Reduction in transplant associated risks
Prevalence of cancer and diabetes in all age groups
High cost of autologous cellular therapies
Lack of skilled professionals
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Covid-19 impact on Autologous Stem Cell and Non-Stem Cell Based Therapies Market 2020 Industry Research, Share, Trend, Industry Size, Price, Future...
Edited Transcript of CDXC earnings conference call or presentation 11-May-20 8:30pm GMT – Yahoo Finance
Irvine May 12, 2020 (Thomson StreetEvents) -- Edited Transcript of Chromadex Corp earnings conference call or presentation Monday, May 11, 2020 at 8:30:00pm GMT
* Kevin M. Farr
* Robert N. Fried
H.C. Wainwright & Co, LLC, Research Division - Equity Research Associate
Ladenburg Thalmann & Co. Inc., Research Division - MD of Equity Research
B. Riley FBR, Inc., Research Division - Senior Analyst
Ladies and gentlemen, thank you for standing by, and welcome to ChromaDex Corporation's First Quarter 2020 Earnings Conference Call. My name is Julianne, and I will be the conference operator today. (Operator Instructions) As a reminder, this conference call is being recorded.
This afternoon, ChromaDex issued a news release announcing the company's financial results for the first quarter 2020. If you have not reviewed this information, both are available within the Investor Relations section of ChromaDex's website at http://www.chromadex.com.
I would now like to turn the conference over to Brianna Gerber, Vice President of FP&A and Investor Relations. Please go ahead, Ms. Gerber.
Thank you. Good afternoon, and welcome to ChromaDex Corporation's First Quarter 2020 Results Investor Call.
With us today are ChromaDex's Chief Executive Officer, Rob Fried; Founder and Executive Chairman, Frank Jaksch; and Chief Financial Officer, Kevin Farr.
Today's conference call may include forward-looking statements, including statements related to ChromaDex's research and development and clinical trial plans and the timing and results of such trials; the timing of future regulatory filings, the expansion of the sale of TRU NIAGEN in new markets, future financial results, business development opportunities, future cash needs, ChromaDex's operating performance in the future and future investor interest that are subject to risks and uncertainties relating to ChromaDex's future business prospects and opportunities as well as anticipated results of operations. Forward-looking statements represent only the company's estimates on the date of this conference call and are not intended to give any assurance as to actual future results. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties. Many factors could cause ChromaDex's actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These risk factors include those contained in ChromaDex's quarterly report on Form 10-Q most recently filed with the SEC. Please note that the company assumes no obligation to update any forward-looking statements after the date of this conference call to conform with the forward-looking statements, actual results or to changes in its expectations.
In addition, certain of the financial information presented in this call references non-GAAP financial measures. The company's earnings presentation and earnings press release, which were issued this afternoon and are available on the company's website, present reconciliations to the appropriate GAAP measures.
Finally, this conference call is being recorded via webcast. The webcast will be available at the Investor Relations section of our website at http://www.chromadex.com.
With that, it's now my pleasure to turn the call over to our Chief Executive Officer, Rob Fried. Rob?
--------------------------------------------------------------------------------
Robert N. Fried, ChromaDex Corporation - CEO & Director [3]
--------------------------------------------------------------------------------
Thank you, Brianna. Good afternoon, everyone, and thank you for joining our first quarter 2020 investor call. I hope everyone listening is navigating well these troubling times.
ChromaDex had another strong quarter with total net sales of $14.3 million. Overall sales increased 10% sequentially and 43% year-over-year. TRU NIAGEN net sales were $11.1 million, a 10% increase sequentially and a 50% increase year-over-year.
Sales to Watsons were down slightly compared to the prior quarter due to the impact of the coronavirus and the protests on retail traffic in Hong Kong stores.
Importantly, our efforts in reducing costs continued to show positive results as adjusted EBITDA, excluding total legal costs was a net loss of $316,000.
ChromaDex reacted swiftly when the coronavirus hit. We already understood that there is an impact on NAD when viruses are present, but we immediately initiated preclinical research in the area in the first quarter, led by our Chief Scientific Adviser, Dr. Charles Brenner. And as you may have noticed, Dr. Brenner published promising results in the initial preclinical study last month. Further research is required and further research is underway.
Additionally, we adjusted our marketing messaging in the first quarter to include the impact that lifestyle, viral and age-related stressors have on our NAD levels and our cellular health. This, in addition to the existing messages of cellular energy, cellular repair and aging.
And finally, we stepped up our ongoing efforts to streamline costs.
With regard to the overall outlook for the year. It is still not clear if COVID '19 will be positive or negative for our business. We're currently expecting a reduction in our top line growth, but improvement in the bottom line results relative to the outlook presented last quarter. This includes some recent changes to our organization as well as some ongoing initiatives across our supply chain. Kevin will provide additional context when he discusses our financial outlook for the year.
Let's now get to the 3 pillars of our business strategy: build a global brand, to own the science, and to focus on the fundamentals. First, the brand. As mentioned, global TRU NIAGEN net sales were $11.1 million in the quarter, a 10% increase sequentially and a 50% increase year-over-year. TRU NIAGEN represented 78% of the $14.3 million in the quarter.
International sales for TRU NIAGEN represented approximately 29% in the first quarter. This includes sales to Watsons in Hong Kong and Singapore, but also cross-border sales in China, Japan, Europe and sales to our partners in Australia, New Zealand, U.K. and Canada.
Sales to Watsons were $1.8 million in the first quarter, a slight decrease versus the previous quarter. Lower sales in the base business in the first quarter were largely offset by shipments for TRU NIAGEN Beauty, which launched in stores in late April. TRU NIAGEN beauty builds on the success of the TRU NIAGEN brand is an award-winning and best-selling health product among Watsons' Hong Kong loyalty members as well as driver of their health care category. The NIAGEN Beauty will allow us to reach new demographics seeking our science-based solutions for their beauty routines. We're pleased to extend our product portfolio with a strong partner like Watsons.
At this time, there are no plans to extend TRU NIAGEN Beauty beyond the region. E-commerce net sales were $8.2 million, a 4% increase sequentially and a 39% increase year-over-year. Sales from returning customers in the U.S. continue to outpace the new customer sales.
In addition, we have cross-border sales in the U.K., Japan, Korea, Germany, France and China, which grew 179% year-over-year. Currently expanding distribution to include 2 of China's largest online retailers, Kaola and JD.com in the second quarter. These platforms will complement our existing Tmall presence in China.
We also added 2 European cross-border markets in the first quarter following the EFSA approval, France and Germany.
Additionally, we're continuing to build our brand with strong global partnerships. We shipped initial orders to the Australia, U.K. and Persona Nutritions in the first quarter, expanding our partnerships with Matakana Superdrug in the U.K., a division of the A.S. Watson Group and Nestl Health Science, respectively.
In late April, we announced that our U.K. partner is Superdrug, a leading health and beauty retailer with over 800 stores in the U.K. and a member of the A.S. Watson Group. This represents our entry into the European market, and we're proud to expand our partnership with the A.S. Watsons Group. As mentioned last quarter, the initial launch is a small test launch in 200 Superdrug stores across the U.K. as well as superdrug.com. We very much applaud the efforts of Superdrug and Watsons for keeping essential items such as TRU NIAGEN available to customers worldwide during this unprecedented time.
We built upon our relationship with Matakana to include exclusive distribution rights in Australia in online and retail channels. Matakana is an established dietary supplement manufacturer and distributor with more than 90 lines of organic and Superfood products. TRU NIAGEN complements, Matakana's existing portfolio of products and their broad distribution as well as knowledge of our science-based product, this positions the brand for strong growth in Australia. We are partnering with them on a number of influencers, social media and earned media initiatives to drive awareness and sales in the market.
We're very much looking forward to the Nestl Health Science, TRU NIAGEN product later this year, which will emphasize the importance of cellular nutrition. As I previously said, the initial test launch will be in loose powder format, and Nestl plans to begin initial marketing efforts next month.
Persona Nutrition, the division of Nestl Health Science launched TRU NIAGEN in the first quarter. Persona is the leader in the fast-growing area of personalized nutrition. We believe it is a growth opportunity for TRU NIAGEN and one that also helps build the brand.
Our second core objective is to own the science. We are confident in the science behind NIAGEN and are actively tracking the increasing volume of research on the molecule that is currently underway. Several new studies have been registered and published since our last update. Frank will summarize in a moment.
Recently, we announced the first round of results of a combination issue, an in vitro study led by Dr. Charles Brenner, our Chief Scientific Officer; one of the world's foremost experts in NAD research as well as Dr. Stan Perlman, one of the leading experts on coronavirus. Dr. Brenner's preclinical study showed 2 key findings: one, a COVID-19 introduction to the studied cells caused greater than threefold reduction in NAD; and two, these infected cells specifically sought out nicotinamide riboside, NIAGEN in an attempt to replenish NAD levels in the face of the viral infection. We expect additional research from Dr. Brenner to be made public soon.
The next phase of his preclinical research will explore whether introducing nicotinamide riboside, or NIAGEN, may support cells innate immune response to coronaviruses and other viruses. We will publicly share the findings of this research when appropriate. We are also exploring additional preclinical research on nicotinamide riboside, or NIAGEN and COVID-19 through our industry-leading ChromaDex external research program.
We also continue to build upon and protect our intellectual property, which includes our ongoing litigation against Elysium Health. A May 12 trial date for the California Litigation was postponed due to court closures in the wake of the coronavirus outbreak. We recently submitted a written joint status report, and the court granted our request for a status conference in June.
New York, discovery has been extended by 4 months due to restrictions on taking depositions in the wake of the coronavirus. And in Delaware, regarding patent infringement by Elysium, it has been scheduled for trial on September 27, 2021. Moving forward following the recent Court of Appeals decision that upheld the validity of the Dartmouth patent, which is licensed by ChromaDex.
To remind everyone, Elysium could not appeal the rejection of their challenge to the 807 patent. Now that Elysium lost their appeal of the PTAB decision validating the 086 patent. Elysium cannot raise those same arguments in the patent infringement lawsuit regarding any claims on the 086 patent. We remain confident in the facts of all 3 cases and are eager to get to trial.
In the meantime, we expect lower near-term legal expense with delays attributable to the coronavirus.
Our third strategic pillar is to focus on fundamentals. It is our mission to lead by example of this industry. During the time when the world is looking for new solutions to maintain their health, we strongly encourage consumers to choose trusted brands, supported by published scientific data with regulatory approvals. We continue our basic philosophy of science-based marketing and conservative financial management. We recently announced the $5 million capital raise to provide some further strength to the already strong balance sheet.
In summary, in the wake of the coronavirus, we are successfully driving the business forward. We are leading important research in the field, delivering on incremental growth opportunities and adjusting our cost structure, maintaining a strong balance sheet. I believe ChromaDex will be even stronger once this global macroeconomic crisis is behind us.
And now I will pass the call over to our Chairman, Frank Jaksch, for an update on scientific research. Frank?
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Frank Louis Jaksch, ChromaDex Corporation - Co-Founder & Executive Chairman [4]
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Thank you, Rob. As Rob stated, one of our core objectives is to own the science. We are committed to remaining a global scientific authority on NR and NAD research as well as setting the standard for excellence in the industry with our commitment to science, safety and quality.
Last call, publication of research on NR and NAD has continued to accelerate with the publication of the Ninth Human Trial and multiple preclinical studies.
As Rob mentioned earlier, Dr. Brenner and scientists from the University of Iowa, Oregon Health and Science University and the University of Kansas recently published preliminary preclinical research on the potential impact coronavirus has on NAD levels in cell, animal and human tissue. The findings were published on BioArchive, a preprint server. The researchers characterized the key steps in what happens in a coronavirus infected cell and the impact it has on a innate immunity.
Before moving on, I want to briefly discuss the concept of a innate versus acquired or adaptive immunity. Acquired immunity is where the body's immune cells have developed specific antibodies after being exposed to a virus and they can quickly seek out the virus and destroy it before it can spread infection. This is how vaccines work using the acquired or adaptive immune response to protect us from viruses.
In contrast, innate immunity is where the cells go to work to fight off the infection when it is first introduced to the body. The body mobilizes immune cells to seek out, attack and destroy the virus. What we've learned from these early publications is that NAD is important for the initial innate or nonspecific response. However, further preclinical research is required in those preclinical studies are underway.
There are 40 ongoing, completed and published clinical trials currently registered on clinicaltrials.gov to investigate the pharmacokinetics and the therapeutic effects of NR. This is 1 more than our last update. An additional 9 clinical trials are registered to test NR in combination with other ingredients for a total of 49. We finished the quarter with 195 signed research collaborations, up by approximately 10 compared to last quarter.
I highlighted an interesting recent published study on NR since we last spoke. In April, a preclinical study demonstrating the effects of both niacinamide and our product, nicotinamide riboside. Supplementation on cardiac electrophysiology was published in the Journal of Molecular and Cellular Cardiology. Researchers from the University of Iowa were able to demonstrate that both NR and NAM increased NAD and NADH levels. However, only NR indicated a potential cardiovascular effect. These results reinforce earlier preclinical findings that suggest increased NAD levels may have a beneficial impact on cardiac conditions and arrhythmias. The researchers concluded that the results warrant further investigation into NR as a potential therapy for cardiac arrhythmic disorders.
Finally, I'll briefly touch on the newly registered clinical studies, all of which were registered in April. First, a study was registered by Ko University Hospital in Turkey to establish metabolic improvements in obese patients with nonalcoholic fatty liver disease, or NAFLD. Through dietary supplementation of NR with the combination of serine, L-carnitine and N-cacetylcysteine. Previous studies have suggested that each of these nutrients decrease liver fat. Thus, the researchers hypothesized that supplementation of a combination of these ingredients, including NR, will stimulate pathways to enhance hepatic oxidation, resulting in decreased liver fat.
Additionally, a pilot study was registered by the Cleveland Clinic, a comprehensive cancer care center to investigate the effects of nicotinamide riboside supplementation in allogeneic hematopoietic cell transplantation. The objective is to find a safe and tolerable way to improve engraftment after transplant. Research studies have shown that adding NR to donor cells has the potential to increase blood stem cell numbers and potentially decrease the time to engraftment.
Before turning the call over to Kevin, I'd like to briefly discuss our new framework for categorizing the areas of ongoing research on NR. In the past, I have discussed studies categorized by various health conditions such as heart health or cardiovascular health, brain health or neurological health, liver health as well as many others. At ChromaDex, we've begun to frame the discussion in the context of a new way of looking at health called intrinsic capacity, which is part of the World Health Organization's framework for healthy aging.
According to WHO, intrinsic capacity is the composite of all mental and physical capacities that a person can draw on, including their ability to walk, think, see, hear and remember. It is an indicator of one's ability to cope with physiological stress and still maintain these functions. We categorize these concepts into 5 domains of intrinsic capacity, vitality, cognition, locomotion, sensory and psychological. In other words, intrinsic capacity is defined by the underlying health of our cells. Nutritional solutions such as NR represent an opportunity to help maintain or even improve intrinsic capacity.
We've included a slide in our earnings presentation, illustrating how cellular health supports intrinsic capacity. Going forward, I'll be presenting the summary of ongoing clinical studies in these intrinsic capacity domains consistent with our internal framework.
In summary, ChromaDex is committed to remaining the leader in the NR, NAD and cellular health conversation. As Rob mentioned, Dr. Brenner's preclinical research is ongoing, and we will provide updates when appropriate.
With that, I'll pass the call over to Kevin Farr. Kevin?
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Kevin M. Farr, ChromaDex Corporation - CFO [5]
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Thank you, Frank. Let's look at our financial results for the first quarter of 2020, which reflected continued progress against our key financial objectives and strong underlying business performance. The underlying business is measured by adjusted EBITDA, excluding total legal expense, approached breakeven in the first quarter with a loss of $316,000. This was a $1.8 million improvement sequentially and a $2.4 million improvement year-over-year. Compared to the fourth quarter of 2019, we delivered strong sequential top line growth, higher gross margins, significant lower advertising expense as a percentage of net sales and lower general administrative expenses primarily driven by the absence of Elysium-related debt expense in the current quarter, partially offset by higher severance and restructuring charges, which are related to cost savings initiatives.
In April, we strengthened our balance sheet with a $5 million common stock raise from existing strategic investors. While there was not an immediate need for the additional capital, we believe it's prudent given the current economic uncertainty. We're always opportunistic if an investor wants to invest capital into the company, and it benefits all of our shareholders.
With this additional $5 million, based upon our current outlook, we believe we have enough cash to reach cash flow breakeven and defend our intellectual property, excluding our $7 million committed line of credit. The line of credit provides additional financial flexibility.
Moving to the first quarter results. For the 3 months ended March 31, 2020, ChromaDex reported net sales of $14.3 million up 10% compared to the $13.1 million in the fourth quarter of 2019. Year-over-year net sales were up 43% compared to the first quarter of 2019.
TRU NIAGEN net sales were up 10% sequentially and grew by 50% year-over-year with diversified growth across U.S. e-commerce, Watsons and international cross-border launches year-over-year. Watsons' sales remained solid at $1.8 million in the quarter, but were down slightly versus last quarter. As expected, Watsons' experienced softer consumer takeaway in the first quarter due to store closures in the wake of the coronavirus. As the economy began to reopen in March, these trends improved, but have yet returned to prior levels. As Rob mentioned, we also shipped our new product TRU NIAGEN Beauty in the quarter, which aligned with Watsons' late April launch. We expect continued impact on sales to Watsons in the second quarter due to the coronavirus.
Total NIAGEN-related net sales were up 8% sequentially and 53% year-over-year. We've experienced strong demand for NIAGEN from our customers.
Turning to the rest of the P&L. On a sequential basis, our gross margin was up 90 basis points from 57.0% in the fourth quarter of 2019 to 57.9% in the first quarter of 2020. Year-over-year gross margin increased by 520 basis points to 57.9% compared to 52.8% in the first quarter of 2019.
As a reminder, last year, we recorded a 250 basis point charge related to the wind down of our purple corn ingredient sales. Product cost savings initiative and overall scale in our supply chain drove the improvement in gross margins. We believe both factors as well as favorable mix from growing TRU NIAGEN consumer product sales represent a tailwind to gross margins in 2020.
On a sequential basis, our total operating expenses for the first quarter of 2020 was $14.2 million, down $2.1 million compared to the fourth quarter of 2019. As a reminder, the fourth quarter of 2019 included a onetime bad debt charge of $2.2 million related to the full write-off of our Elysium receivable.
Our selling and marketing expenses were down $0.7 million to $4.4 million in the first quarter of 2020 compared to $5.1 million in the fourth quarter of 2019. As a percentage of net sales, this expenditure was down 800 basis points in the first quarter of 2020 versus the fourth quarter of 2019.
We made continued progress, improving marketing efficiency in our TRU NIAGEN business driven by strong returning customer growth while investing in initiatives to drive new customer growth, both in the U.S. and internationally. We continue to monitor daily e-commerce metrics such as customer acquisition costs to adjust messaging and spending, which is increasingly important in this fluid environment.
As reported, G&A expense was down $1.3 million to $8.8 million in the first quarter of 2020 versus $10.1 million in the fourth quarter of 2019. This included $2.4 million of legal fees and $1.0 million of severance and restructuring expenses in the current quarter. Excluding legal fees, severance, restructuring and equity compensation expense, first quarter 2020 G&A expense was lowered by $0.1 million versus the fourth quarter of 2019 comparable G&A expense, which also excluded Elysium-related bad debt expense.
Legal expense was up slightly compared to the fourth quarter of 2019. Motions for summary judgment when we decided following hearings in the California matter during the first quarter, and discovery accelerated in the New York litigation.
Sequentially, the trial was delayed in California case due to the suspension of all jury trials caused by the coronavirus. For the same reason, deposition discovery was delayed in New York.
As a result, we expect legal expense to be lower in the second quarter of 2020 despite ongoing investments in the Delaware patent infringement case in preparation for the Markman Hearing in December 2020, and the trial in September 2021.
For the first quarter of 2020, our operating loss was $5.9 million versus $8.9 million in the fourth quarter of 2019, which included the $2.2 million bad debt write-off. The net loss attributable to common shareholders for the first quarter of 2020 was $5.9 million or a loss of $0.10 per share as compared to the net loss of $8.9 million or a loss of $0.15 per share for the fourth quarter of 2019. The fourth quarter of 2019 net loss per share included the $0.04 per share bad debt expense.
As we said, we believe it's important to focus on sequential trends in our business to demonstrate progress towards cash flow breakeven. To help investors better engage the underlying performance of our business in the second quarter of 2019, we introduced a new non-GAAP measure adjusted EBITDA, excluding total legal expense. ChromaDex defines adjusted EBITDA, excluding total legal expense as net income or loss, which is adjusted for income tax, interest, depreciation, amortization, noncash stock compensation costs, bad debt expense related to Elysium, severance and restructuring expenses and total legal spending. We have included a reconciliation to the appropriate GAAP measures in our earnings release slide.
Litigation expenses represents the majority of our legal spend today. We are excluding total legal spending from adjusted EBITDA since we expect to decline significantly after the matters are concluded.
In the fourth quarter of 2019, we began excluding severance and restructuring expenses that we expect to deliver measurable, sustainable net cost savings in late 2020 and beyond. We made changes to the organization in the first quarter and completed negotiations as part of our end-to-end supply chain evaluation.
On an annualized basis, we identified at least $2 million of gross savings, with the majority of the savings delivered to be realized in 2021. We incurred $1.2 million of severance and restructuring expenses related to these cost savings initiatives. As is prudent in this uncertain economic environment, we'll continue to evaluate our cost structure and see additional opportunities in our supply chain.
As I previously highlighted, adjusted EBITDA, excluding total legal expense improved by $1.8 million to a loss of $0.3 million in the first quarter of 2020 compared to a loss of $2.1 million in the fourth quarter of 2019.
Year-over-year, we delivered a $2.4 million improvement in the first quarter of 2020 versus a loss of $2.7 million in the first quarter of 2019. The improvement in the first quarter of 2020 was primarily driven by higher sales and gross margins and marketing efficiency.
Moving to the balance sheet and cash flow. We ended the first quarter of 2020 with cash of $13.6 million, down $5.2 million versus the fourth quarter of 2019.
In the first quarter of 2020, our net cash used in operation was a negative $5.2 million versus a negative $0.6 million in the fourth quarter of 2019.
Consistent with our expectation, the higher cash outflows from operations this quarter was driven by working capital, which is a $1.6 million use of cash in the first quarter of 2020 compared to a $3.9 million source of cash in the fourth quarter of 2019. The use of cash in the first quarter was related to an increase in accounts receivable and a decrease in accounts payable, largely due to lower NIAGEN ingredient purchases.
Today, we've successfully navigated the business during the coronavirus pandemic. At this time, we do not expect any supply to change disruptions from coronavirus and have implemented risk assessment strategies to manage this going forward.
As it relates to revenues, the COVID-19 situation remains fluid and difficult to predict. Against this backdrop, we are managing our expenses to mitigate the bottom line impact to the company.
As Rob said, we took a hard look at our 2020 financial plan to ensure we're prioritizing investments with the highest return in the current environment.
For full year 2020, we expect continued top line growth driven by our U.S. e-commerce business, launches in new international markets such as the U.K. and Australia, and launches on new platforms such as Persona Nutrition. As we have said, we anticipate a lower growth rate than the 47% in 2019 due to: a larger revenue base, the impact of the coronavirus and the impact to divesting our Spherix regulatory consulting business, which accounted for roughly $700,000 of 2019 net sales.
As Rob mentioned, we see the coronavirus having impact on Watsons in the second quarter. There has also been a modest impact in our HCP business where some sales are tied to trade shows, which have been canceled.
COVID-19 may also impact our international market launches at retail, but these are incremental opportunities relative to 2019. It's too early to determine the impact of the coronavirus on our e-commerce sales. Consumers are likely to balance concerns about employment, overall macroeconomic weakness with their desire to invest in their health with supplements like TRU NIAGEN.
Based on the trends to date, we're planning for continued growth in this business in 2020. We continue to expect gross margin expansion due to the favorable mix from our growing e-commerce business, the product design changes implemented in late 2019 and additional supply chain cost savings initiatives.
We continue to expect an increase in selling and marketing expense of $3 million to $5 million, including investments in brand awareness and investments in new market launches. We expect continued improvement in selling and marketing expense as a percentage of net sales driven by strong sales growth from returning customers.
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Edited Transcript of CDXC earnings conference call or presentation 11-May-20 8:30pm GMT - Yahoo Finance
How Becoming A Partisan Weapon Will Destroy Medicine – The Federalist
In the past year, it seems politics will leave no rock unturned. Every aspect of our lives is becoming politicized. The NBA. The NFL. Nike. Thanksgiving. Now medicine.
This is even more dangerous than it first appears. Recently, an online video by ER doctors Daniel Erickson and Artin Massihi went viral. They expressed views that differed from the presiding media narrative on COVID-19.
Swiftly, the video was censored by YouTube, and their own professional organizations, the American Academy of Emergency Medicine (AAEM), and the American College of Emergency Physicians (ACEP), released a bizarrely aggressive statement accusing the doctors of financial conflicts of interest without any supporting evidence.
I saw truth in both sides scientific positions, but this statement was very strange from a medical professional organization, especially the personal accusation. Im not aware of any time in modern medical history this has happened.
As a legislator, it smelled of politics. As a physician, it didnt seem right for a professional society to accuse board-certified physicians of expressing their opinion for financial gain without any evidence whatsoever.
If ACEP and AAEM would have left things within the scientific realm, I wouldnt have thought much of it. But they wentfurther.Why? ACEP and AAEM were trying to personally discredit these physicians. And they did so by conjecture.
Our country is in trouble. Mutually exclusive worldviews now hinder the quest for scientific truth. The accelerated politicization of medicine has me more concerned than ever.
Political takeovers have already occurred in other medical societies. Not surprisingly, the first big split was within the OB-GYN specialty over abortion. The American College of Obstetricians and Gynecologists (ACOG) first moved to the left by openly supporting abortion, and in 1973 the American Association of Pro-Life OB-GYNs (AAPLOG) was born. Because of ACOGs increasingly aggressive support of abortion, many pro-life physicians have left the organization. ACOG and AAPLOG cut ties in 2013.
The pediatric medical organizations have undergone a similar split, with transgenderism at the center of debate. The American College of Pediatricians (ACP) has been the target of many attacks from the left due to their position statements on sexuality and transgenderism. The ACP has been labeled an anti-LGBT hate group by the Southern Poverty Law Center. In 2017, as the politics continued rile the medical world, the American Academy of Pediatricians (AAP) suddenly flipped on their position on parental notification for abortion. The AAP is now an LGBTQ lifestyle advocacy group.
My local medical society succumbed to the same political polarization in early 2019 when they voted to endorse a radical pro-abortion bill. As I sat at the table during the debate, a few of us argued that the medical society should stay away from this legislation, and that we should preserve our uniqueness to contribute to society purely from a medical perspective, not a political one.
The council ignored this warning, and voted for the endorsement. After this, I knew I could not continue paying dues to a society that endorsed abortion, so I publicly renounced membership.
Among the many things I love about practicing medicine is that all my patients have the same condition: the human condition. My patients arent Republicans or Democrats. Theyre just people needing help.
Our medical societies used to be fairly politically neutral, and stuck to pure medicine. Now as partisan groups, theyve put medical credibility into a state of crisis: a crisis of legitimacy. If doctors want to use their medical knowledge to further propagate their worldview, they should just go work on a political campaign.
My greatest fear as I observe the leftist takeover of medicine is dehumanization. Leftist ethicists are advocating for human genetic engineering without restrictions all in the name of progress. This technology is flirting with the field of eugenics, leading us deeper down the road to dehumanization of the human person.
Remember the controversial 2016 Super Bowl ad that humanized the fetus? Just a few months prior, the Scientific American published an article entitled, The Truth About Fetal Tissue Research. The article was fraught with subtle politicized language, labelling groups anti-abortion instead of their pro-life identity as well as falsely claiming abortion constitutes only 3 percent of Planned Parenthoods services.
It also mentioned a researcher at UNC-Chapel Hill who tried to humanize a mouse for fetal tissue research, stating Using fetal tissue is not an easy choice, but so far there is no better choice.No better choice than to use humans who were purposefully killed in the name of science. Let that sink in.
Medicine is unraveling, and the crisis of legitimacy in the field has begun. American doctors are not immune to this phenomenon, as political worldview clearly now trumps science. Somehow leftist scientists believe they own the realm of scientific fact. They intend to advance their worldview, and their science has devolved into scientism. After all, the scientific method is about coming to a conclusion, not starting with one.
Many doctors and scientists simply capitulate. Those who dont? Well, we just saw what happened to Drs. Erickson and Massihi. When you speak truth to power in a time of unmitigated tyranny, power will silence and slander you.
This isnt the first time, either. Kenneth Zucker, a psychologist, was recently removed from the program of a transgender conference due to threats of violence and outrage posturing from the other speakers. Open debate is the enemy of dogma.
Its hard to say which is the greater risk to the practice of medicine: doctors influence over policy, or over their patients. Doctors with a leftist ideology have been known to readily recommend sex-change hormones to young children. I know physicians who have seen some of these children whose parents are seeking a third or even fourth opinion. When they are seen by a doctor with a conservative worldview, they receive a different diagnosis and are presented with alternatives to pre-pubescent hormone treatment.
Political wars are won with the battle over education. The left took over journalism schools decades ago, and we can all plainly see the medias bias today. They have successfully infected medical schools as well.
I took the Hippocratic Oath as a medical student. In its original form, this oath explicitly forbids the practices of abortion and euthanasia. Most medical schools now utilize the ever-changing Geneva Convention instead.
We have a crisis of legitimacy in modern medicine. Doctors opinions now come with a large dose of worldview. Our nations leaders would do well to understand that. Our civilization depends on it.
Gregg Schmedes, MD, serves in the New Mexico House of Representatives, representing District 22. He resides in Tijeras, New Mexico with his wife and six children.
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How Becoming A Partisan Weapon Will Destroy Medicine - The Federalist
Here’s Why You Might Want To Add Orgasms To Your Daily Skin Care Routine – Essence
When it comes to the quest to look forever young, there isnt much that women with maturing skin wont try (vampire facials, breast milk anyone?). But some unique hacks are just a lot more fun than others.
Megwyn White, Director of Education for Satisfyer, a premier maker of satisfaction toys and gadgets, agrees. According to White, orgasms are an inexpensive and effective way to increase your natural glow. And renowned Obstetrics and Gynecology Physician Tosha Rogers seconds that assertion.
According to these experts, here are a four key ways orgasms can keep your skin looking and feeling younger and glowing longer:
1. During an orgasm, a surge of endorphins and oxytocin are released from the brain. These hormones and chemicals regulate and lower cortisol levels, which in turn helps to reduce inflammation and naturally ward off skin ailments. Oxytocin is really known as the cuddle hormone,' says Dr. Rogers. It is the anti-stress, which is why it lowers the cortisol levels, which is the stress hormone. Anything that creates happiness and decreases stress decreases inflammation.
2. Orgasms also help to raise estrogen levels, which supports collagen growth in the body, aiding in the prevention of wrinkles and aging skin. Estrogen also helps to lock in the skins moisture, keeping skin hydrated and plump, according to White.
3. Orgasms facilitatebetter beauty sleepthrough the production of hormones and neurotransmitters, including prolactin and serotonin, which both help toinduce and regulate deep, non-rem sleep. Orgasms help elevate the levels of dopamine in the brain, Dr. Rogers explains. This acts as a satisfied hormone and produces a sense of comfort and euphoria, thus resulting in better sleep.
4. Additionally, sexual activity increases blood flow and circulation, allowing for more oxygen-filled blood cells to reach your face, which can result in a radiant look. Orgasmic expression also increases micro-expressions within the face, supporting the elasticity and tone of tissues which might otherwise be caught in contractive patterns which can result in wrinkle formation, says White.
So whether youre getting it on with a partner, or quarantined solo, you can still use this lesser explored option to get your skin together. And while anything can be bad for you in excess, theres very little worry that youll overdo it in this instance.
Overstimulation is absolutely possible when it comes to the body, White explains. That being said, the female body is capable of having multiple orgasms, with a shorter refractory (recovery) period in between climaxes. If a woman is capable of multiple orgasms, she shouldnt worry about the amount, but rather whether the stimulation itself feels overly aggressive or intense. If she experiences any pain or discomfort, its important to take a break.
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Here's Why You Might Want To Add Orgasms To Your Daily Skin Care Routine - Essence
Edited Transcript of IMMU earnings conference call or presentation 6-May-20 9:00pm GMT – Yahoo Finance
MORRIS PLAINS May 12, 2020 (Thomson StreetEvents) -- Edited Transcript of Immunomedics Inc earnings conference call or presentation Wednesday, May 6, 2020 at 9:00:00pm GMT
Immunomedics, Inc. - Executive Chairman
* Brendan P. Delaney
Immunomedics, Inc. - Chief Commercial Officer
Immunomedics, Inc. - Senior Director of IR
Immunomedics, Inc. - CFO & Chief Business Officer
* Nicholas M. Abbott
* Philip M. Nadeau
Good afternoon, ladies and gentlemen. Thank you for standing by. As a reminder, this call is being recorded. Today is Wednesday, May 6, 2020. At this time, I would like to turn the conference over to Chau Cheng, Senior Director of Investor Relations of Immunomedics.
Chau Cheng, Immunomedics, Inc. - Senior Director of IR [2]
Thank you, Jimmy. Before we begin, I'd like to remind everyone that during this call, we will be making forward-looking statements made pursuant to the Private Securities Litigation Reform Act of 1995. Such statements may involve significant risks and uncertainties, and therefore, actual results could differ materially from those expressed or implied on this call. Factors that could cause such a difference include the uncertainty associated with pharmaceutical development and the regulatory approval process as well as difficulties in forecasting sales, revenues and expenses.
More information about the risks and uncertainties faced by Immunomedics, Immunomedics business contained with the caption Risk Factors under -- included in the company's periodic report filed with the Securities and Exchange Commission, including the company's annual report on Form 10-K for the year ended December 31, 2019.
With us on the call today with prepared remarks are Dr. Behzad Aghazadeh, Executive Chairman, and Usama Malik, Chief Financial Officer and Chief Business Officer. Also on the call for Q&A are Harout Semerjian, President and Chief Executive Officer; and Brendan Delaney, Chief Commercial Officer. Following the prepared remarks, we will open the call up for questions. Thank you. Behzad?
Behzad Aghazadeh, Immunomedics, Inc. - Executive Chairman [3]
Thank you, Chau. Good afternoon, everyone, and thank you for joining us. We entered 2020 with strong momentum. While the first quarter was primarily focused on completing the FDA review and executing on ongoing priorities, the last several weeks have been monumental for the company. The hard work, commitment and dedication of our colleagues at Immunomedics over the last 3 years have culminated into a series of accomplishments that establish us as a fully integrated commercial biopharmaceutical company. The approval of TRODELVY by the FDA exemplifies our commitment to deliver breakthrough therapies to help transform the lives of those with hard-to-treat cancers.
This commitment is further demonstrated by our commercial team. We were successful in making TRODELVY available to people with mTNBC shortly upon FDA approval. As noted in our press announcement this past Monday, TRODELVY was shipped to our specialty distributors last week, and the first patient was treated with commercial product exactly a week ago today, exactly one week after FDA approval.
Equally importantly, our regulatory and market access teams have already completed a National Drug Rebate Agreement with The Centers for Medicare & Medicaid Services. As a result of our teams mobilizing quickly, for Medicaid specifically, states are now generally obligated to cover TRODELVY as of July 1, 3 months ahead of our scheduled time line and a big win for Medicaid patients. The rebate agreement is also prerequisite for Medicare.
Another key event this year is the early halting of this Phase III ASCENT study due to compelling evidence of efficacy across multiple endpoints. We have begun the process of cleaning the database, which will result in database lock and ultimately the unblinding of the study. Top line readout remains on track for mid-year 2020.
We also look forward to the top line data from the first cohort of 100 patients who were previously exposed to platinum-based and PD-1 and PD-L1 inhibitor therapies in the TROPHY U-01 study of patients with metastatic urothelial cancer. As previously disclosed, these data could potentially support a BLA submission for accelerated approval to the FDA, which has recently granted TRODELVY Fast Track designation in this indication.
For the second cohort of patients who are platinum ineligible and have progressed after prior checkpoint inhibitor therapy, an abstract containing early results has been accepted for poster presentation at this year's ASCO virtual meeting. An additional abstract from the Phase I/II study of TRODELVY in patients with previously treated metastatic endometrial cancer has also been accepted for poster presentation at the same conference.
In other clinical development, we have entered into a clinical collaboration with the Dana-Farber Cancer Institute and Merck to study the combination of TRODELVY with pembrolizumab, an antiPD-1 antibody in 2 separate Phase II studies. The first study involves approximately 110 patients newly diagnosed with PD-L1 negative mTNBC. These patients will be randomized to receive the combination of TRODELVY and pembro versus TRODELVY alone. The same combination of TRODELVY and pembro will be used in the second randomized study in approximately 110 hormone treatment and chemo-refractory patients with PD-L1 positive hormone receptor, positive HER2-negative metastatic breast cancer. Both studies will have PFS, or progression-free survival, as the primary end point. Overall survival, overall response rate, duration of response and clinical benefit rate will be used as secondary end points.
Financially, the company completed an oversubscribed public offering, and we have added approximately $465 million to our balance sheet. Furthermore, the approval of TRODELVY triggered a $60 million contractual milestone payment from Everest Medicines, our partner in China, who recently announced the approval by the Chinese regulatory authority to initiate a pivotal Phase III study of TRODELVY in mTNBC in China, which they begin to plan -- which they plan to begin in the first half of 2020.
At this exciting inflection point of the company's growth, I'm also pleased to announce that Dr. John Stubenrauch has been appointed Senior Vice President, Global Head of Manufacturing. John is a seasoned executive with decades of experience with companies like AstraZeneca and Merck. He brings a strong foundational background in global commercial manufacturing. John will spearhead the initiatives that continue to scale our global supply chain, ensure supply continuity and focus of cost of goods optimization. With John's new role, Dr. Morris Rosenberg is stepping down as Chief Technology Officer with the company, which will be effective later in May.
I would like to thank Morris, who was seminal in helping us develop our initial clinical and commercial supply chain and manufacturing processes. Morris will be pursuing a new opportunity closest to his home in the Pacific Northwest that is focused on new product development. We wish him the very best in his future endeavor and will keenly follow his progress. Thank you, Morris. I know you're listening.
Usama will now go over the financials.
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Usama Malik, Immunomedics, Inc. - CFO & Chief Business Officer [4]
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Thank you, Behzad. As in the past, please refer to our quarterly filing as well as our earnings release this afternoon for additional details of our results.
Total costs and expenses were $82 million for the 3 months ended March 31, 2020, compared to $79.6 million for the comparable quarter ended March 31, 2019. The increase was primarily due to a $4.3 million increase in R&D expenses and a $0.2 million increase in sales and marketing expenses, partially offset by a $2.1 million decrease in G&A expenses.
Interest expense was $13.5 million for the 3 months ended March 31, 2020, compared to $10 million for the comparable quarter March 31, 2019. The increase was due primarily to changes in the fair value of our debt balances as a result of the agreement with Royalty Pharma. Net loss was $93 million or $0.44 per share for the quarter ended March 31, 2020, compared to a net loss of $87.3 million, also $0.46 per share for the comparable quarter ended March 31, 2019.
As of March 31, 2020, the company had $540 million in cash, cash equivalents and marketable securities. On May 1, 2020, the company closed on its previously announced underwritten public offering of common stock with net proceeds of approximately $464 million. The number of outstanding shares after the capital raise were 231 million, and the fully diluted count was 242 million.
As Behzad alluded to earlier, we expect to receive $60 million from Everest Medicines triggered by FDA approval of TRODELVY. We believe our projected financial resources are adequate to support the commercial launch of TRODELVY in the United States in mTNBC and continue to expand the clinical development programs for TRODELVY, invest in the broader clinical development of the ADC platform, continue to scale up of manufacturing and manufacturing process improvements and general working capital requirements.
This concludes our first quarter 2020 financial results, and I will pass it back to Behzad.
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Behzad Aghazadeh, Immunomedics, Inc. - Executive Chairman [5]
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Before we open it up for questions, a few words to update on the impact the coronavirus pandemic is having on our business. With the shelter-in-place recommendations taking effect, we quickly move to remote access and work from home for all nonessential personnel. We have implemented stringent on-site monitoring and as much as feasible, undertaken social distancing measures for essential on-site staff, who predominantly are comprised of colleagues in our manufacturing and quality operations. As a result, thankfully, operations have been minimally impacted to date.
With respect to our ongoing clinical trials, we announced in late March that we were pausing enrollment of new patients and activation of new sites. While it is too early to assess the precise extent of disruption to the conduct of our trials, we are confident that the impact will be manageable. In particular, the pivotal Phase III ASCENT study, which completed enrollment in mid-2019, was halted following the independent DSMC recommendation. We anticipate very limited impact from the pandemic.
The pivotal 100-patient cohort of platinum eligible urothelial cancer in the TROPHY U-01 study also fully enrolled as of October 2019 and had significant follow-up already completed pre-COVID-19. So again, we do not anticipate significant impact.
And finally, following persistent requests from investigators, the Phase III TROPiCS-02 study of TRODELVY in hormone-receptor positive HER2-negative metastatic breast cancer will be resuming enrollment beginning later this month at select sites that have been carefully vetted for their ability to ensure normal clinical trial operations and patient safety.
On behalf of all of my colleagues at Immunomedics, our thoughts and well wishes are with those impacted by the coronavirus pandemic. Further, I would like to express our thanks to the workers who are providing essential services and helping mitigate the disruption to our lives as well as recognize the medical personnel who are combating this disease on the front lines. I would also like to extend my special gratitude to my colleagues at Immunomedics who continue to work tirelessly towards fulfilling our mission of delivering these breakthrough medicines to patients in need. As the lines between the days of the week, the evenings and nights and the weekends have blurred, we find ourselves often putting in even more hours than prior to the outbreak. I understand this phenomena is playing out across our sector and no doubt also beyond. May this all pass soon.
Operator, please open the call for questions.
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Questions and Answers
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Operator [1]
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(Operator Instructions) Our first question comes from Phil Nadeau with Cowen and Company. Once again, our next question comes from Phil Nadeau with Cowen and Company.
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Behzad Aghazadeh, Immunomedics, Inc. - Executive Chairman [2]
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Operator, we're getting e-mails from folks that are having hard time getting on the Q&A line. Is there -- can you check the lines?
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Operator [3]
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(Operator Instructions) The next question in the queue comes from Michael Schmidt with Guggenheim.
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Behzad Aghazadeh, Immunomedics, Inc. - Executive Chairman [4]
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Operator, I have a note here that says there are some issues with the dial-in. All sound has dropped.
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Operator [5]
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One moment, please. Testing audio for now. The next question in the queue is -- goes to Michael Schmidt with Guggenheim.
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Michael Werner Schmidt, Guggenheim Securities, LLC, Research Division - Senior Analyst & Senior MD [6]
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All right. Can you hear me?
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Behzad Aghazadeh, Immunomedics, Inc. - Executive Chairman [7]
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Yes, we can Mike. Well, I don't know how much of what we have to say you heard.
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Michael Werner Schmidt, Guggenheim Securities, LLC, Research Division - Senior Analyst & Senior MD [8]
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Yes, I don't know. I just hear the operator. Well, anyway, so why don't I just ask a question? The one I had was on TROPiCS-02. Can you -- really appreciate the comments you made on enrolling the study and the investigator enthusiasm. We've gotten some questions really on understanding the read-through to the successfully of this study from the ASCENT trial? And maybe if you could just help us understand the timing potentially of the interim analysis that you've talked about, which is based on response rate? And also help us understand how we should think about potential benchmarks here on the control arm in this trial?
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Behzad Aghazadeh, Immunomedics, Inc. - Executive Chairman [9]
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Sure, Michael. Thanks. Look, we haven't provided timing on when the interim might occur, and that was even before the coronavirus pandemic took hold. And it's really too early to judge exactly what happens from here on. Up until the time when we stalled the enrollment or stopped initiating new study sites, we were enrolling extremely well. And so once we resume here, hopefully, we can regain momentum pretty quickly, and that will then inform us when we would take that interim. And as we get closer, we'll certainly communicate the time lines. But my hope is that the delays or disruptions will be very limited and entirely manageable.
With respect to the benchmark, what we generally said is, obviously, these are distinct patient populations with triple negative, on the one hand. On the other hand, in the very late-line and refractory setting, where we're studying this drug in TROPiCS-02, we're told by the physician community that the patient population presents themselves with a very similar outlook to the triple-negative community. And the chemo options available to them, in fact, very much the same ones that they would be using in the triple-negative opportunity -- setting. And those are exactly what comprised the control arm, which is cap, gem, eribulin and vinorelbine.
So as a result, my expectation would be -- and based on some literature work that we've done, obviously, all retrospective, albeit some of them are more recent contemporaneous study, I would expect response rates on the order of high single digit, low double digit. And I would expect duration of responses of perhaps 3 or so months, very much similar to the triple-negative opportunity. Now that is, I want to heavily caveat that. It's based on literature and the feedback we're getting. And obviously, this is why we're running the study. But those are generally the benchmarks I would use, which is why I'm hopeful and encouraged by this assessment by the DSMC on ASCENT that it will hopefully also translate over into what to read it -- what TROPiCS-02 will read out as.
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Michael Werner Schmidt, Guggenheim Securities, LLC, Research Division - Senior Analyst & Senior MD [10]
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Great. Then maybe just a question on TRODELVY and the initial experience. Now I realize it's only been a short amount of time since the drug's been on the market. But just wondering if you could just share a little bit of initial feedback and whether the initial experience has met your expectations so far?
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Brendan P. Delaney, Immunomedics, Inc. - Chief Commercial Officer [11]
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Yes. Brendan Delaney here. Yes. So I would say in a nutshell so far so good. It's early, as you recognize. But I think we manage the launch, especially in these first 2 weeks on almost an hourly basis, and we're meeting all the tactical implementation and things from that perspective. So certainly, internally, I think we're meeting all our guidelines. I think it was important as we announced that the drug was available within days, which was an important kind of milestone that we are holding ourselves to because we know patients are waiting. And so, so far, so good I would say, I think the feedback from physicians, as you can imagine, physicians are excited for their patients, obviously, but the reaction to the prescribing information and the support services and top to bottom, what we've put out there is pretty well received so far. So it's early, as I said, but so far, so good. We're pleased.
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Operator [12]
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(Operator Instructions) Our next question comes from Peter Lawson with Barclays.
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Peter Richard Lawson, Barclays Bank PLC, Research Division - Research Analyst [13]
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Congratulations on the progress. As we think about the launch, what type of metrics do you anticipate providing going forward? And kind of the milestones you're setting yourself internally, how are you kind of viewing a successful launch? And I guess that's particularly pertinent if we think about in this time of kind of social distancing.
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Winter is coming for Australia, along with fears of spike in Covid infections – ThePrint
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Canberra: Six weeks after shutting down swathes of the economyto contain the coronavirus, Australia is preparing to relax its lockdown on Friday. There could be a cost new clusters of infections just as the southern hemisphere heads into winter.
Closing restaurants, cinemas and pubs and urging people to largely stay at home have seen the daily rate of new infections plunge to less than 0.5% from 20% about a month ago. Along with extensive testing and contact tracing, the restrictions have bought Australias health system time to prepare for new outbreaks, as Prime Minister Scott Morrison looks to reboot the crippled economy.
The country of 25.7 million people, which had recorded 6,875 cases and 97 deaths as of Wednesday, will be among the first developed nations to test the resilience of its health system by lifting restrictions just as the weather turns colder. Morrison, whos heralded his governments success in flattening the curve, says the health system is in a good position to cope as he now turns to resuscitating the economy.
When we move and start to ease some of these restrictions, of course you will see numbers increase in some areas, you will see outbreaks occur in other places, Morrison told reporters this week. What matters is how you deal with it, and how you respond to it.
While seasonal flu often flares in winter in temperate climates, scientists are still investigating whether temperature plays a role in the coronavirus outbreak. Australias experience may offer clues to what may happen a few months from now in the northern winter.
Australia has so far avoided thescale of sickness and deaththats ravaged countries including the U.K., U.S. and Italy. Peter Collignon, an infectious diseases physician and professor at the Australian National University Medical School, says Australias handling of the outbreak has put it in probably the best position in the world.
We closed borders very early, have had strong quarantine measures, traced just about every case and convinced the vast majority of Australians to adhere to social-distancing restrictions, Collignon said. Of course, the virus hasnt been eliminated, so we need to avoid thinking things will quickly return to business as usual.
In late January, Morrison announced the first of a string of border controls and enforced quarantine measures to limit and test arrivals from virus hotspots. He closed the nation to non-residents on March 19. Most Australian states and territories also imposed their own border restrictions.
Health authorities have ramped up testing and contact tracing. According toWorld Economic Forum data, as of April 26 the nation had conducted 19.9 diagnostic tests for Covid-19 per 1,000 people, compared with 15.6 tests in the U.S., 9.9 tests in the U.K and 1.8 in Japan. Some 5 million people have downloaded mobile-phone software designed to help trace coronavirus infections, though the government says thats still not enough for it to be effective.
In the past six weeks, Australia has also ramped up the number of intensive-care unit beds, most of which are currently idle. Initial shortfalls of personal protection and medical equipment have, in the main, been identified and alleviated.
According to Collignon, the island continent has also benefited from its geographic isolation and the fact that its population mainly lives in suburban or regional areas, rather than in crowded cities. Still, hes urging the government to not wind backsocial-distancing restrictions, particularly for mass gatherings, until after winter.
Theres some basic principles that we cant compromise too much, particularly as winter is coming, because theres a risk that this will jump up and bite us again, he said.
Also read: Testosterone-reducing hormone therapy could help protect men against Covid: Italian study
At the heart of Australias early success has been the cooperation between Morrisons federal government and the eight state and territory governments, which have put aside political rivalries to largely work in unison. Some states, which have seen days without new infections, have already started to relax social-distancing measures allowing picnics, water sports,hikingin national parks and reopening schools.
But there have been missteps. The most populous state of New South Wales and federal authorities fell into a blame game over why thousands of passengers were allowed to disembark theRuby Princess cruise shipin Sydney in March, even through 13 people on board suffered flu-like symptoms. Hundreds of cases across the nation and at least 20 deaths have been linked to the cruise ship.
The lockdown has taken a heavy economic toll: unemployment is poised to double by July to about 10% and the nation is veering toward its first recession in almost three decades. With restrictions costing the economy an estimated A$4 billion ($2.4 billion) a week, Morrison is keen to relax measures and has been drafting Covid-safe guidelines to help businesses return to work.
But the risks are clear. A cluster of almost 50 cases at ameat processing plant in Victoria stateis a reminder of how outbreaks can emerge and potentially get out of hand, particularly with winter approaching.
Its a very sobering reminder that if the government and the private sector want to get the economy back to some kind of normality, it will probably come at a cost, said Mary-Louise McLaws, an infectious diseases expert at the University of New South Wales.-Bloomberg
Also read: WHO wants to go to China again as search for origin of coronavirus heats up
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Winter is coming for Australia, along with fears of spike in Covid infections - ThePrint
Gamida Cells Bone Marrow Transplant Cuts Treatment Time in Phase… – Labiotech.eu
A rapid-acting bone marrow transplant developed by the Israeli biotech Gamida Cell was engrafted in blood cancer patients 10 days faster than standard umbilical cord blood transplants in a phase III trial.
The trial recruited 125 blood cancer patients in more than 50 clinical centers globally. One group received a standard transplant of donor umbilical cord blood cells and another group received Gamidas treatment omidubicel, which consists of umbilical cord blood cells that are expanded and cultured in the lab.
According to the trial results, omidubicel established itself in the patients and started making healthy new immune cells after around 12 days, measured by counting cells called neutrophils in the blood. This was significantly faster than the 22 days it took in patients given a regular umbilical cord blood transplant.
Blood cancer patients often receive stem cell transplants to replace bone marrow cells that are damaged by chemotherapy or radiation therapy. Donor stem cell transplants can come from adult bone marrow cells, stem cells in the blood, or umbilical cord blood stem cells.
A common problem with bone marrow transplants is compatibility, where the donors cells could fail to engraft or even attack the recipient if the cell types dont match properly. This problem is less common in umbilical cord blood transplants than other sources, but this type of transplant also provides a lower dose of stem cells, which can delay the engraftment process.
To solve this issue, Gamida Cells treatment is designed to take donor umbilical cord cells and boost their stem cell count in the lab prior to administering the treatment to patients.
These results have the potential to substantially move the field forward and represent an important step toward making stem cell transplantation more accessible and more successful for patients with lethal blood cancers, stated Mitchell Horwitz, Principal Investigator and Professor of Medicine at the Duke Cancer Institute, USA.
Shortening the time to engraftment is clinically meaningful, as it can reduce a patients time in the hospital and decrease the likelihood of infection.
The company aims to apply for FDA approval in late 2020, with a potential commercial launch in 2021. According to a conference call today, Gamida Cell had completed its phase III enrollment in December. This meant that the trial was luckily unaffected by the onset of the Covid-19 pandemic, which has delayed clinical trials for many companies worldwide.
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Gamida Cells Bone Marrow Transplant Cuts Treatment Time in Phase... - Labiotech.eu
Cellect Biotechnology Announces Positive Data Demonstrating Robust Engraftment Using ApoGraft was Featured in Bone Marrow Transplantation; Primary…
TEL AVIV, Israel, May 11, 2020 /PRNewswire/ -- Cellect Biotechnology Ltd. (NASDAQ: APOP), a developer of innovative technology which enables the functional selection of stem cells, today announced the publication of an article in Bone Marrow Transplantation, a peer-reviewed medical journal )member of the Nature publishing house) covering transplantation of bone marrow in humans and published monthly by the prestigious Nature Research, entitled 'Ex-vivo FAS-ligand to Improve Allograft Safety'. The article is co-authored by researchers at Cellect and its academic partners.
The paper highlights the pre-clinical research and demonstrates that engraftment is robust following transplantation of treated graft, and the graft retains its immune reconstitution and anti-leukemic effects. The Company has initiated a Phase 1/2 study in adults undergoing stem cell transplant for the treatment of hematological malignancies. The primary endpoint of the study is to evaluate the overall incidence, frequency, and severity of adverse events potentially related to ApoGraft at 180-days post-transplant. All patients transplanted through present time using the ApoGraft process were engrafted and time to engraftment was similar to the standard of care. To date, there have not been any safety and tolerability concerns during the study and patient enrollment is continuing. Both, the principal investigator (PI) and independent data safety monitoring board (DSMB) agree that no serious adverse events (SAEs) reported during the course of the study were related to the ApoGraft process.
The data from the pre-clinical research, and published in this paper, was included in the Company's Investigational New Drug (IND) application, which was approved by the U.S. Food and Drug Administration in late 2019. The Company has received all the necessary approvals to initiate the trial with its academic partner, Washington University, and plans to begin patient recruitment once the COVID-19 pandemic is mitigated and clinics can resume normal practices.
About Cellect Biotechnology Ltd.
Cellect Biotechnology (NASDAQ: APOP) has developed a breakthrough technology, for the selection of stem cells from any given tissue, that aims to improve a variety of stem cell-based therapies.
The Company's technology is expected to provide researchers, clinical community and pharma companies with the tools to rapidly isolate stem cells in quantity and quality allowing stem cell-based treatments and procedures in a wide variety of applications in regenerative medicine. The Company's current clinical trial is aimed at bone marrow transplantations in cancer treatment.
Forward Looking Statements
This press release contains forward-looking statements about the Company's expectations, beliefs and intentions. Forward-looking statements can be identified by the use of forward-looking words such as "believe", "expect", "intend", "plan", "may", "should", "could", "might", "seek", "target", "will", "project", "forecast", "continue" or "anticipate" or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. For example, forward-looking statements are used in this press release when we discuss Cellect's expectations regarding timing of the commencement of its planned U.S. clinical trial and its plan to reduce operating costs. These forward-looking statements and their implications are based on the current expectations of the management of the Company only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. In addition, historical results or conclusions from scientific research and clinical studies do not guarantee that future results would suggest similar conclusions or that historical results referred to herein would be interpreted similarly in light of additional research or otherwise. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: the Company's history of losses and needs for additional capital to fund its operations and its inability to obtain additional capital on acceptable terms, or at all; the Company's ability to continue as a going concern; uncertainties of cash flows and inability to meet working capital needs; the Company's ability to obtain regulatory approvals; the Company's ability to obtain favorable pre-clinical and clinical trial results; the Company's technology may not be validated and its methods may not be accepted by the scientific community; difficulties enrolling patients in the Company's clinical trials; the ability to timely source adequate supply of FasL; risks resulting from unforeseen side effects; the Company's ability to establish and maintain strategic partnerships and other corporate collaborations; the scope of protection the Company is able to establish and maintain for intellectual property rights and its ability to operate its business without infringing the intellectual property rights of others; competitive companies, technologies and the Company's industry; unforeseen scientific difficulties may develop with the Company's technology; the Company's ability to retain or attract key employees whose knowledge is essential to the development of its products; and the Company's ability to pursue any strategic transaction or that any transaction, if pursued, will be completed. Any forward-looking statement in this press release speaks only as of the date of this press release. The Company undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws. More detailed information about the risks and uncertainties affecting the Company is contained under the heading "Risk Factors" in Cellect Biotechnology Ltd.'s Annual Report on Form 20-F for the fiscal year ended December 31, 2019 filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC's website, http://www.sec.gov, and in the Company's periodic filings with the SEC.
Contact
Cellect Biotechnology Ltd.Eyal Leibovitz, Chief Financial Officerwww.cellect.co+972-9-974-1444
Or
EVC Group LLCMichael Polyviou+732-933-2754mpolyviou@evcgroup.com
SOURCE Cellect Biotechnology Ltd.
Company Codes: NASDAQ-SMALL:APOP, TelAviv:APOP
Read more from the original source:
Cellect Biotechnology Announces Positive Data Demonstrating Robust Engraftment Using ApoGraft was Featured in Bone Marrow Transplantation; Primary...