Archive for October, 2019

To develop Ocugens orphan drug designated gene therapy candidate in its modifier gene therapy platform

Ocugen, Inc., a UK based clinical stage biopharmaceutical company focused on innovative therapies that address rare and underserved eye diseases, has entered into a strategic partnership with China based CanSino Biologics on Ocugens gene therapy pipeline product candidates for inherited retinal diseases, which are currently in development with Schepens Eye Research Institute of Massachusetts Eye and Ear, an affiliate of Harvard Medical School.

Under this strategic collaboration, CanSinoBIO will provide all CMC development and clinical supplies for the development of OCU400, Ocugens first gene therapy product candidate in its modifier gene therapy platform. CanSinoBIO maintains the option to support commercial manufacturing for Ocugen. The agreement also provides commercialization rights to CanSinoBIO in Greater China.

OCU400 has received two different orphan drug designations (ODD) from the U.S. FDA. The first, for the treatment ofNR3E3mutation-associated retinal degeneration and, most recently, for the treatment ofCEP290mutation-associated retinal disease.

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CanSino partners with Ocugen to work on gene therapy - BSA bureau

Astellas Pharma Inc. will invest $12.5 million in two innovation incubators operated by LabCentral, a U.S.-based lab facility for next-generation biotech start-ups. Astellas has previously committed more than $1 billion to drive innovation in Massachusetts to accelerate the discovery and development of potential breakthrough therapies in areas of significant unmet need.

"Astellas has a long-standing commitment to the Boston-area life sciences ecosystem, where world-class talent are dedicated to turning innovative science into value for patients," said Kenji Yasukawa, Ph.D., President and CEO, Astellas. "Our presence in the greater Boston area comprises over 200 professionals across several locations driving innovation in regenerative medicine, immuno-oncology, mitochondrial function, genetic regulation and beyond. Accelerating early-stage scientific innovation in areas such as cell and gene therapy is a strategic focus for Astellas, and is superbly aligned with the mission of LabCentral to serve as a launching-pad for cutting-edge biotech and life sciences start-ups."Astellas will invest $12.5 million to become the only pharma/biopharma company among five Founding Sponsors of a new incubator, which will feature a core lab space where companies can easily conductprocess development studies and a non-GMP pilot plant, being developed by LabCentral in Cambridge. The investment provides support to start-up companies and entrepreneurial founders seeking to create scientific innovation in areas of unmet need such as cell and gene therapy. The new incubator is expected to be operational in 2021.Astellas will also invest at least $450,000 over three years to become a Gold Sponsor of LabCentral's existing incubator located at 700 Main Street in Cambridge.By supporting these incubators, Astellas can select, support and access innovation from leading start-ups creating healthcare solutions in its areas of focus.Since 2010, Astellas has invested more than $800 million in, and committed nearly $500 million more to, Massachusetts-based innovation through the acquisitions of Ocata Therapeutics, Inc., Mitobridge, Inc. and Potenza Therapeutics, Inc., as well as the construction of a state-of-the-art headquarters for the Astellas Institute for Regenerative Medicine (AIRM) in Westborough, MA. The new facility, expected to open in 2020, will enable AIRM to accelerate research and development in the field of regenerative medicine and cell therapy.

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Astellas to Fund Boston-Area Cell and Gene Therapy Start-Up - Contract Pharma

SAN FRANCISCO--(BUSINESS WIRE)--Audentes Therapeutics, Inc. (Nasdaq: BOLD), a leading AAV-based genetic medicines company focused on developing and commercializing innovative products for serious rare neuromuscular diseases, today announced its planned presentations at the 24th International Annual Congress of the World Muscle Society in Copenhagen, Denmark, including new data from ASPIRO, the clinical trial evaluating AT132 in patients with X-linked Myotubular Myopathy. The oral presentation will be given by Dr. James J. Dowling, Hospital for Sick Children, Toronto, Canada, and will be held during the Clinical Trial Highlights 7 session of the conference on Saturday, October 5 beginning at 1:00pm Central European Summer Time (CEST)/7:00am Eastern Time (ET).

Dr. Dowling will present new efficacy and safety data from the ASPIRO Phase 1/2 dose escalation cohorts (10 treated patients and 2 controls). Efficacy analyses will include assessments of ventilator dependence and achievement of developmental motor milestones.

We are excited to share new efficacy and safety data from our ASPIRO study, stated Natalie Holles, President and Chief Operating Officer. The data from these dose escalation cohorts, along with results from our ongoing pivotal expansion cohort, will form the basis of the AT132 BLA submission planned in mid-2020, and MAA submission planned for the second half of 2020.

Audentes is planning several additional presentations during the conference, including a company-sponsored symposium that will provide an in-depth review of XLMTM and the ASPIRO study results. Following are details for each presentation:

Oral Presentation:

ASPIRO Gene Therapy Trial In X-Linked Myotubular Myopathy (XLMTM): Update on Preliminary Safety And Efficacy FindingsSession: Clinical Trial Highlights 7Date and time: Saturday, October 5, 1:00-2:00pm Central European Summer Time (CEST)/7:00am-8:00am Eastern Time (ET)Abstract number: O.39

Poster Presentation:

INCEPTUS Pre-Phase 1, Prospective, Non-Interventional, Natural History Run-in Study to Evaluate Subjects Aged 4 Years and Younger with X-Linked Myotubular Myopathy (XLMTM)Session: Congenital myopathies: centronuclear and othersDate and time: October 2, 2019, 4:45pm - 6:45pm Central European Summer Time (CEST)/10:45am 12:45pm Eastern Time (ET)Abstract number: P.105

Audentes-Sponsored Symposium:

Altering the Treatment Paradigm: Gene Therapy for Neuromuscular DisordersDate and time: Friday, October 4, 1:15pm2:45pm Central European Summer Time (CEST)/7:15am 8:45am (ET)Location: Axelborg Hall

Agenda and Speakers:AAV Gene Therapy for Neuromuscular DisordersBenedikt Schoser, MD (Chair)Friedrich-Baur Institute, Ludwig-Maximilians University, Munich, Germany

Gene Therapy for XLMTM: The ASPIRO Study

The Potential of AAV for Neuromuscular DisordersEdward Conner, MDSenior Vice President and Chief Medical Officer, Audentes Therapeutics, San Francisco, CA, USA

Improvements in XLMTM Muscle Pathology and BiomarkersMichael W Lawlor, MD, PhDDepartment of Pathology and Laboratory Medicine and Neuroscience Research Center, Medical College of Wisconsin, Milwaukee, WI, USA

Achieving Ventilator Independence with AT132 in XLMTMRobert Graham, MDDivision of Critical Care Medicine, Boston Childrens Hospital, Boston, MA, USA

Attaining Motor Developmental Milestones in Children with XLMTMLaurent Servais, MD, PhDMuscular Dystrophy UK Oxford Neuromuscular Centre, Oxford, UK and Lige University, Lige, Belgium

About X-linked Myotubular Myopathy

X-linked Myotubular Myopathy (XLMTM) is a serious, life-threatening, rare neuromuscular disease that is characterized by extreme muscle weakness, respiratory failure, and early death. Mortality rates are estimated to be 50 percent in the first 18 months of life, and for those patients who survive past infancy, there is an estimated additional 25% mortality by the age of 10. XLMTM is caused by mutations in the MTM1 gene that lead to a lack or dysfunction of myotubularin, a protein that is needed for normal development, maturation, and function of skeletal muscle cells. The disease affects approximately 1 in 40,000 to 50,0000 newborn males.

XLMTM places a substantial burden of care on patients, families and the healthcare system, including high rates of healthcare utilization, hospitalization and surgical intervention. More than 80 percent of XLMTM patients require ventilator support, and the majority of patients require a gastrostomy tube for nutritional support. In most patients, normal developmental motor milestones are delayed or never achieved. Currently, only supportive treatment options, such as ventilator use or a feeding tube, are available.

About AT132 for the treatment of XLMTM

Audentes is developing AT132, an AAV8 vector containing a functional copy of the MTM1 gene, for the treatment of X-linked Myotubular Myopathy (XLMTM). AT132 may provide patients with significantly improved outcomes based on the ability of AAV8 to target skeletal muscle and increase myotubularin expression in targeted tissues following a single intravenous administration.

Audentes has reported promising safety, efficacy, and muscle biopsy data from ASPIRO, an ongoing, multicenter, ascending dose clinical study designed to evaluate the safety and efficacy of AT132. The preclinical development of AT132 was conducted in collaboration with Genethon (www.genethon.fr).

AT132 has been granted Regenerative Medicine and Advanced Therapy (RMAT), Rare Pediatric Disease, Fast Track, and Orphan Drug designations by the U.S. Food and Drug Administration (FDA), and Priority Medicines (PRIME) and Orphan Drug designations by the European Medicines Agency (EMA).

About Audentes Therapeutics, Inc.

Audentes Therapeutics (Nasdaq: BOLD) is a leading AAV-based genetic medicines company focused on developing and commercializing innovative products for serious rare neuromuscular diseases. We are leveraging our AAV gene therapy technology platform and proprietary manufacturing expertise to develop programs across three modalities: gene replacement, vectorized exon skipping, and vectorized RNA knockdown. Our product candidates are showing promising therapeutic profiles in clinical and preclinical studies across a range of neuromuscular diseases. Audentes is a focused, experienced and passionate team driven by the goal of improving the lives of patients.

For more information regarding Audentes, please visit http://www.audentestx.com.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, the timing and nature of the ASPIRO pivotal expansion and the ASPIRO clinical data results and the timing and nature of regulatory filings for AT132. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Although the company believes that the expectations reflected in such forward-looking statements are reasonable, the company cannot guarantee future events, results, actions, levels of activity, performance or achievements, and the timing and results of biotechnology development and potential regulatory approval is inherently uncertain. Forward-looking statements are subject to risks and uncertainties that may cause the company's actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to the company's ability to advance its product candidates and obtain regulatory approval of and ultimately commercialize its product candidates, the timing and results of preclinical and clinical trials, the company's ability to fund development activities and achieve development goals, the company's ability to protect intellectual property and other risks and uncertainties described under the heading "Risk Factors" in documents the company files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and the company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.

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Audentes Announces Upcoming Presentations at the 24th International Annual Congress of the World Muscle Society, Including New Data From ASPIRO, the...

A study has revealed that using DNA-like molecules to repair gene mutations in models could act as a successful therapy for patients.

Researchers have used a promising new therapeutic to treat Duchenne muscular dystrophy (DMD) in human muscle cells and mice models. According to the researchers, their treatment could aid as many as 47 percent of patients with the condition.

The study, conducted by the University of Alberta, US, investigated whether using a group of DNA-like molecules would result in regrowth of a protein called dystrophin, which supports muscle strength. Patients with DMD often severely lack this protein.

In muscle, if there is no dystrophin there is no support of muscle membrane and the muscle cells will become easily damaged or destroyed, said Toshifumi Yokota, a professor of medical genetics at the university. Our DNA-like molecules restore the production of dystrophin so it can support the muscle cell membrane.

The team used a mix of DNA-like molecules, known as antisense oligonucleotides, to act in the manner of a stitch to repair a specific gene mutation in patients.

Our treatment produces a shorter dystrophin protein than the drug being used now. This shorter protein is associated with extremely mild symptoms in some of the muscular dystrophy patients. Some have almost no symptoms at all, explained Yokota.

The researchers are now working to reduce the number of DNA-like molecules in the mixture to reduce both cost and regulatory hurdles moving forward. They hope to progress the work to a clinical trial in the future.

The results were published in Molecular Therapy.

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Researchers find DNA therapy could treat patients with DMD - Drug Target Review

I favor running analogies even the name of this column pays tribute to the sport. But Im not the first patient advocate to evoke that ancient sport of quicker-than-average terrestrial locomotion. After all, we are racing to treatments because time is critical.

But in the fight against a rare condition like Batten disease, success involves much more than speed. You may be fast, but have you studied the course? Do you know its twists and turns? Do you have a team and support crew, or are you competing alone? Are you ready to take on unexpected obstacles?

Do you have what it takes?

Therapy development isnt for the faint of heart, but patients can and absolutely do make an impact on potentially life-saving treatments and the science and regulatory issues involved. Last month, I joined my mom, Taylors Tale President Sharon King, and Steven Gray, PhD, associate professor at University of Texas Southwestern Medical Center, onstage at the Global Genes RARE Patient Advocacy Summit to discuss that topic.

If you didnt make it to San Diego for the summit this year, I hope you had a chance to tune in to the livestream. If you didnt, or if youd like a recap, following are nine things that we shared about pushing promising work toward the finish line.

Like a marathon, the race to find treatments and cures isnt easy. Few people see the long hours in the lab or the thousands of experiments that dont produce a single breakthrough or correct answer. Miracles happen in science, but results come with a lot of hard work and some luck.

If you want to see a treatment for you or someone you love, you have to accept that it wont be easy. This race is hard. Youll feel winded. Youll get injured. Youll crave water stops. Youll get passed by someone running faster than you. Youll pass someone who doesnt want it as much as you do.

In his new book Chasing My Cure, my friend, David Fajgenbaum, writes, Fear disintegrates. Doubt disorganizes. Hope clears the way, pushes out the horizon, and gives us space to build structures.

Heres what I think David meant by that:

Being invincible in hope means having the courage and the will to take action. You cant trust and wait. You cant assume that someone else will swoop in to save the day. Thats not what hope means.

Instead, you have to look inward. You have to take an active role in transforming hope into reality. Thats hope in action.

Thats how you change the world.

Never doubt that a small group of thoughtful, committed citizens can change the world. Indeed, it is the only thing that ever has. Margaret Mead

***

Note: Batten Disease News is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website. The opinions expressed in this column are not those of Batten Disease News or its parent company, BioNews Services, and are intended to spark discussion about issues pertaining to Batten disease.

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9 Things We Should Know About the Race to New Treatments - Batten Disease News

STONY BROOK, N.Y.--(BUSINESS WIRE)--LineaRx, Inc., the majority-owned subsidiary of Applied DNA Sciences, Inc. (NASDAQ: APDN) focused on next-generation biotherapeutics, announced today that its invasive Circulating Tumor Cells (iCTCs) platform demonstrated superior correlation over Prostate Specific Antigen (PSA) in an ongoing Phase II trial in recurrent prostate cancer. Most notably, the concentration of rare iCTCs identified per milliliter of whole blood correlated more directly with disease status than did the levels of PSA. These iCTCs were captured and identified utilizing LineaRxs technology platform recently acquired from Vitatex Inc.

LineaRxs collaborator Tyme Technologies, Inc. (NASDAQ: TYME), reported yesterday results of this recently completed Phase II trial using SM-88 to treat recurrent prostate cancer at the Congress of the European Society of Medical Oncology (ESMO), one of the preeminent meetings for highlighting new cancer therapies and diagnostics. The study updated the safety and antitumor effects of SM-88 in men with non-castrate non-metastatic prostate cancer. Antitumor effects were assessed by post-therapy changes in PSA and the number of iCTCs. Results showed that patients treated with this oral non-hormonal therapy maintained metastases-free survival without testosterone deprivation or typical hormonal therapy side effects.

Dr. Wen-Tien Chen, Principal Investigator of CTC Programs at LineaRx stated: This use of iCTC quantification for providing earlier and more accurate identification of prostate cancer shows the importance of running trials using the iCTC functional capture and identification system from LineaRx. Published studies have shown that the concentration of iCTCs in blood correlates with disease status across other hard tumors, including metastatic sarcoma, pancreatic, ovarian, breast, lung and colorectal cancers. We believe our proprietary platform can help diagnose these difficult cancers earlier and with superior predictive capability.

The current reported SM-88 Phase II study examines iCTCs in prostate cancer for what we believe is the first time in a clinical trial. While PSA has historically been the recognized biomarker for prostate cancer, many studies over the last 20 years have shown it is an inadequate biomarker, since it may become elevated in patients with no apparent disease, or less serious pathology than cancer. Intensive efforts have been directed towards alternative prostate cancer biomarkers, particularly those that can predict disease aggressiveness and help to drive better treatment decisions. However, biomarker research has centered on disease diagnostics, rather than prognosis and prediction, which could work toward disease preventionan important focus moving forward.

The authors concluded: "Reductions in iCTC number may be a more informative indicator of benefit than changes in PSA. Dr. Chen added, New prostate cancer biomarkers should be targeted to addressing unmet clinical needs in prostate cancer management, including indicators for disease with low PSA values (<10ng/mL), prognostic markers to distinguish indolent from aggressive disease, and biomarkers for metastatic cancer.

LineaRxs iCTC technology is unique in that it isolates iCTCs on a functional basis (the invasion of a model tissue for the extracellular matrix, or the tissue between cells in an organ) and allows the cells to be cultured for deeper genomic analysis. iCTCs are a model for metastasis, since the tumor cells have left the primary tumor and entered the circulation. The LineaRx platform may serve as a standalone device or as a front-end to increase the sensitivity of approved diagnostics.

iCTCs have the potential for metastasis, and may be very useful in the diagnosis of cancer, even before tumors may be imaged, said Dr. James Hayward, CEO of LineaRx. The present study is exciting because we believe it shows that iCTCs may be used to accurately follow therapy success in this very prevalent cancer while also providing new tools for cell and gene therapy design and production.

About Tyme Technologies, Inc

Tyme Technologies, Inc., is an emerging biotechnology company developing cancer therapeutics that are intended to be broadly effective across tumor types and have low toxicity profiles. Unlike targeted therapies that attempt to regulate specific mutations within cancer, Tyme Technologies, Inc.s therapeutic approach is designed to take advantage of a cancer cells innate metabolic weaknesses to compromise its defenses, leading to cell death through oxidative stress and exposure to the bodys natural immune system. For more information, visit http://www.tymeinc.com. Follow Tyme Technologies, Inc. on social media: @tyme_Inc, LinkedIn, Instagram, Facebook and YouTube.

About LineaRx

LineaRx seeks to commercialize the biotherapeutic value of Applied DNAs deep expertise and experience in the design, manufacture and chemical modification of DNA by large scale polymerase chain reaction (PCR). Linear DNA is a form of DNA distinct from the circular form of DNA most commonly produced in plasmids and grown in bacteria. Plasmids are extrachromosomal DNA found in bacteria and are associated with the genes for antibiotic resistance which are often exchanged between bacteria and consequentially, are seen by many to embody a serious threat to global health. In addition, many nucleic acid-based therapies also rely on viral vectors for efficient transfection and expression of plasmid DNA. These viral vectors carry additional nontrivial risks and are extremely time consuming and expensive to manufacture. Go to http://www.adnas.com for more information on LineaRx and to learn more about how Applied DNA makes life real and safe. LineaRx is a majority-owned Applied DNA Sciences, Inc. (Nasdaq: APDN) company.

About Applied DNA Sciences

Applied DNA is a provider of molecular technologies that enable supply chain security, anti-counterfeiting and anti-theft technology, product genotyping and pre-clinical nucleic acid-based therapeutic drug candidates.

Applied DNA makes life real and safe by providing innovative, molecular-based technology solutions and services that can help protect products, brands, entire supply chains, and intellectual property of companies, governments and consumers from theft, counterfeiting, fraud and diversion.

Visit adnas.com for more information. Follow us on Twitter and LinkedIn. Join our mailing list.

Common stock listed on NASDAQ under the symbol APDN, and warrants are listed under the symbol APDNW.

Forward-Looking Statements

The statements made by Applied DNA in this press release may be forward-looking in nature within the meaning of the Private Securities Litigation Act of 1995. Forward-looking statements describe Applied DNAs future plans, projections, strategies and expectations, and are based on assumptions and involve a number of risks and uncertainties, many of which are beyond the control of Applied DNA. Actual results could differ materially from those projected due to the risk that the acquisition will not be successfully integrated with LineaRx or that the potential benefits of the acquisition will not be realized, the Companys history of net losses, limited financial resources, limited market acceptance , the uncertainties inherent in research and development, future clinical data and analysis, including whether any of Applied DNAs product candidates will advance further in the preclinical research or clinical trial process, including receiving clearance from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies to conduct clinical trials and whether and when, if at all, they will receive final approval from the U.S. FDA or equivalent foreign regulatory agencies, uncertainties relating to its ability to maintain its NASDAQ listing in light of delisting notices received and various other factors detailed from time to time in Applied DNAs SEC reports and filings, including our Annual Report on Form 10-K filed on December 18, 2018, as amended, and our subsequent quarterly reports on Form 10-Q filed on February 7, 2019,May 9, 2019 and August 13, 2019, and other reports we file with the SEC, which are available at http://www.sec.gov. Applied DNA undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date hereof to reflect the occurrence of unanticipated events, unless otherwise required by law.

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LineaRx's iCTC Platform for Isolation of Circulating Tumor Cells Shows Superior Correlation over PSA as a Biomarker in Prostate Cancer Trial -...

The Universities of Bristol and Nottingham will share over 500k to lead a consortium of experts on research projects into bioengineered blood and soft tissue regeneration, respectively. The research could not only save lives, but could also improve the quality of lives of injured personnel.

The funding is awarded at Phase 2 of the Defence and Security Accelerator (DASA) Regenerative Medicine themed competition which is facilitated and managed by the Defence Science and Technology Laboratory (Dstl) on behalf of the MOD, in partnership with the Academic Department of Military Surgery and Trauma (ADMST).

Dealing with damage caused by blast or ballistic trauma, which may involve significant blood loss and multiple complex wounds, is a challenge for even the most sophisticated medical facility. Yet to do this in the austere and remote environments within which the military operate further complicates the delivery of medical care.

Approaches in tissue engineering and regenerative medicine hold great promise for the treatment of injured service personnel and the new Defence regenerative medicine research strategy is focussed on delivering such advanced therapies in a way suitable for use in the field early after injury.

The 500k funding will enable the University of Bristol to continue its research to engineer a multi-compatible blood type, with an improved storage profile, that could be used to treat military personnel regardless of their blood type. This could transform the logistics of transporting and storing blood supplies on the front line. In the longer term, first responders like paramedics could also benefit from the portability of a blood supply that is suitable for all.

The University of Nottingham will continue to research a novel approach to preserve and regenerate soft tissue after blast and ballistic trauma through transient gene therapy. Preserving living tissue after injury is critically important, and will significantly improve quality of life.

Dave Henson, co-founder of the CASEVAC club, a support network for individuals that were severely wounded in combat, said:

Understanding that saving a life on the battlefield without due consideration for the future quality of that life is nonsensical. Significant progress has been made in the medical arena throughout the duration of recent conflicts. The development of technologies such as were seeing in this latest of the DASA competition, with the reduction in burden associated with blood supplies, and the immediate improvement of wound management techniques, provides strong assurances that the functional outcome from battlefield trauma will continue to improve.

Dr Abi Spear, Technical Lead for the regenerative medicine project at Dstl said:

Im delighted that the Universities of Bristol and Nottingham have won this Phase 2 competition. Their work represents innovative, discovery science thats high risk but with potentially huge clinical benefit.

Dr Adam Staines, Themed Competition Lead, DASA:

We are pleased that this competition has harnessed cutting edge bio-medical research that seeks to make a real difference on the front line and could also have positive implications for the civilian market in future too.

The Dstl regenerative medicine research strategy looks to support research in four areas, as defined by an evidence-based scoping study, through a variety of activities, including funding and collaboration. If you would like more information on the project as a whole please email DSTLRegenDefenceAccelerator@dstl.gov.uk.

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Defence investment set to transform recovery from combat trauma - GOV.UK

People with spinal muscular atrophy (SMA) type 1 may have an increased risk of impaired kidney function, a small study suggests.

The studys findings highlight the need to further evaluate non-muscular conditions associated with SMA type 1 and to identify co-adjuvant therapies to manage them.

The research was published in the article, Impaired kidney structure and function in spinal muscular atrophy, in the journal Neurology Genetics.

SMA is caused by mutations in theSMN1 gene, which leads to reduced production of the SMN protein. While motor nerve cells are those most vulnerable to SMN deficiency, decreased levels of this protein occur throughout the body, which may contribute to the development of the disease.

With new therapies to treat all types of SMA, including type 1 (the most common and one of the most severe types), patients are living longer, and thus the overall impact of SMN deficiency beyond motor function needs to be evaluated, scientists say.

In addition, an increased risk of renal toxicity is listed on the insert for Spinraza, the first therapy approved by the U.S. Food and Drug Administration to treat SMA, and similar therapies have been associated with acute tubular injury, the researchers wrote.

With this in mind, they evaluated whether kidney function was impaired in 13 children with SMA type 1 who died due to SMA complications.

Analysis of blood data showed that most of the children had values outside of the expected range for several molecules associated with kidney function, including creatinine and cystatin C. Most of them also had potentially harmful aggregates, called granular casts and amorphous crystals, and high levels of amino acids (the building blocks of proteins) in their urine, which are all linked with kidney damage.

Molecular and morphological analyses of kidney tissues of 12 patients as well as age- and sex-matched children without SMA showed that two-thirds of the SMA patients had several abnormalities highly associated with kidney disease.

Kidney tissues of children with SMA type 1 showed varying degrees of tubular damage, with scarring and abnormal calcium deposits, and significant changes in the levels of genes associated with kidney toxicity or kidney cystic disease.

Also, they had low levels of CaSR and CALB1 (proteins involved in the maintenance of their calcium balance, thus preventing accumulation of calcium deposits) and high levels of IGFBP1 and IGFBP3 which has been associated with kidney damage and dysfunction compared with the non-SMA children.

The researchers noted all these features were consistent with kidney dysfunction more specifically kidney tubular dysfunction which strongly suggests that most of the children with SMA type 1 had impaired kidney function before death.

Therefore, the study recommends that physicians consider this increased risk of impaired kidney function when treating their patients with SMA type 1.

The researchers also noted that since these patients are now living longer due to recently approved treatments, kidney disease may become a significant comorbidity, and future research should focus on identifying therapies to manage kidney dysfunction.

Future studies will be important to determine whether impaired kidney function is a primary consequence of reduced SMN protein, a secondary consequence of muscle atrophy and bone disease, or more likely a combination of both, the researchers said.

Total Posts: 85

Ana holds a PhD in Immunology from the University of Lisbon and worked as a postdoctoral researcher at Instituto de Medicina Molecular (iMM) in Lisbon, Portugal. She graduated with a BSc in Genetics from the University of Newcastle and received a Masters in Biomolecular Archaeology from the University of Manchester, England. After leaving the lab to pursue a career in Science Communication, she served as the Director of Science Communication at iMM.

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SMA Type 1 Kids May be at Higher Risk of Kidney Dysfunction, Study Says - SMA News Today

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Longevity And Anti-senescence Therapy Market Research on Trend, Demand and Precise Outlook 2019-2025 - The Ukiah Post

Gene Therapy Market look into report is a in-depth analysis of current situation of the market, which covers a few market dynamics. A isolate area with Gene Therapy industry key players is incorporated into the report, which gives a far reaching investigation of sales and revenue, value, cost, gross, product picture, details, organization profile, and contact data. The Market Report additionally gives a diagnostic appraisal of the prime difficulties looked by Gene Therapy Market at present and in the coming years, which helps Market members in understanding the issues they may face while working in this Market over a more extended timeframe.

Market Segmentation: Key Players

Avalanche BioAdvantageneDimension TherapeuticsBluebird BioSangamoCelladonVical Inc.Spark Therapeutics

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The report gives the concise examination report of the Gene Therapy Market showcase around the United States. The Gene Therapy think about contributes tasteful answer for the client. The examination think about incorporates investigation, Gene Therapy market forecast and income from 2019 to 2026. The Gene Therapy report unveils the near outcome between various players spread in the United States. It likewise gives the different kinds of sections of the Gene Therapy market seeing to the item, for example, type, Regions/Countries, application and players. Current and refreshed Gene Therapy trends likewise included to the report.

This Gene Therapy report analyzes the global market by the following segments:

Global Gene Therapy Market Analysis By Product Types:

In VivoEx Vivo

Global Gene Therapy Market Analysis By Product Applications:

Cardiovascular DiseasesInfectious DiseasesMonogenic DiseasesCancer DiseasesOthers

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Gene Therapy Industry fragment based on research regions:

The fundamental regions analyzed in this report include North America, Europe, Asia-Pacific, Middle East& Africa and South America. The growth rate and production value are analyzed for these regions. Further, the above regions are bifurcated to provide country-level Gene Therapy industry statistics for the below countries.

North America region covers the United States, Canada and the rest of the countries

Europe regions cover the Gene Therapy market statistics for Germany, The UK, France, Netherlands, Italy, Spain and rest of the countries

Asia-Pacific region covers the industry analysis for China, Japan, Korea, India, and rest

The Middle East and African Gene Therapy market caters to South Africa, Israel, UAE and rest

South America covers countries like Brazil, Colombia, Argentina and rest

The global Gene Therapy research report plots a part of the key players existing in the Gene Therapy Market, close by point to point investigation. The report delineates each one of the concentrations concerning how showcase players are going for the creating market part of various locales. Recent strategic association, organization, assention, mergers, and acquisitions occurring in the global Gene Therapy showcase are being fused. The basic progress included towards the examination of entire market regard, in view of end-customer Gene Therapy advertise and land areas.

Research Report Covers

Gene Therapy Market Overview. Global Gene Therapy Market Competition by Manufacturer.

Global Gene Therapy Capacity, Production, Revenue(value) by region(2014-2019).

Global Gene Therapy Supply(Production), Consumption, Export, Import By Region(2014-2019)

Global Gene Therapy Capacity, Production, Revenue(value), Price Trend by Type.

Global Gene Therapy Market Analysis By Application.

Global Gene Therapy Manufacturers profiles/Analysis

Global Gene Therapy Manufacturing Cost Analysis

Industrial chain, sourcing strategy and downstream buyers.

Marketing stratergy analysis, Distributors/Traders.

Global Gene Therapy Market Forecast Analysis(2019-2026).

Research Finding and Conclusions.

Appendix.

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Global Gene Therapy Market- Industry Growth, Trends, New Tech Developments, Revenue Predicted to 2026 - Space Market Research

BERKELEY, Calif., Oct. 1, 2019 /PRNewswire/ --Today, the U.S. Patent and Trademark Office (USPTO) granted a new CRISPR-Cas9 patent to the University of California (UC), University of Vienna, and Dr. Emmanuelle Charpentier covering new methods of the gene-editing technology in prokaryotic cells. The new patent (U.S. Patent No. 10,428,352) covers methods of targeting and binding or methods of cleaving a target DNA in a prokaryotic cell using Cas9 protein and single molecule DNA targeting RNAs. This patent also specifically covers these methods in bacterial cells.

This is the fifth consecutive week that the USPTO has awarded a CRISPR-Cas9 patent to UC, which has immensely increased the compositions and methods covered in the portfolio. The university's total portfolio to-date includes 16 patents, marking the largest CRISPR-Cas9 patent portfolio in the country, and will rise to 18 in the coming weeks, once other applications that the USPTO has allowed are issued as patents. The extensive portfolio covers compositions and methods for the CRISPR-Cas9 gene-editing technology, including targeting and editing genes and modulating transcription in any setting, such as within plant, animal, and human cells.

"The continuous issuance of CRISPR-Cas9 patents to UC adds significant new compositions and methods to our burgeoning portfolio that has quickly become the widest-ranging for the technology," said Eldora L. Ellison, Ph.D., lead patent strategist on CRISPR-Cas9 matters for UC and a Director at Sterne, Kessler, Goldstein & Fox. "We are pleased by the USPTO's ongoing recognition of the Doudna-Charpentier team's leadership related to CRISPR-Cas9."

The Doudna-Charpentier team that invented the CRISPR-Cas9 DNA-targeting technology included Jennifer Doudna and Martin Jinek at the University of California, Berkeley; Emmanuelle Charpentier (then of Umea University); and Krzysztof Chylinski at the University of Vienna. The methods covered by today's patent, as well as the other compositions and methods claimed in UC's previously issued patents and those set to issue, were included among the CRISPR-Cas9 gene editing technology work disclosed first by the Doudna-Charpentier team in its May 25, 2012 priority patent application.

Additional CRISPR-Cas9 patents in this team's portfolio include 10,000,772; 10,113,167; 10,227,611; 10,266,850; 10,301,651; 10,308,961; 10,337,029; 10,351,878; 10,358,658; 10,358,659; 10,385,360; 10,400,253; 10,407,697; 10,415,061; and 10,421,980. These patents are not a part of the PTAB's recently declared interference between 14 UC patent applications and multiple previously issued Broad Institute patents and one application, which jeopardizes essentially all of the Broad's CRISPR patents involving eukaryotic cells.

International patent offices have also recognized the pioneering innovations of the Doudna-Charpentier team, in addition to the 16 patents granted in the U.S. so far. The European Patent Office (representing more than 30 countries), as well as patent offices in the United Kingdom, China, Japan, Australia, New Zealand, Mexico, and other countries, have issued patents for the use of CRISPR-Cas9 gene editing in all types of cells.

University of California has a long-standing commitment to develop and apply its patented technologies, including CRISPR-Cas9, for the betterment of humankind. Consistent with its open-licensing policies, UC allows nonprofit institutions, including academic institutions, to use the technology for non-commercial educational and research purposes.

In the case of CRISPR-Cas9, UC has also encouraged widespread commercialization of the technology through its exclusive license with Caribou Biosciences, Inc. of Berkeley, California. Caribou has sublicensed this patent family to numerous companies worldwide, including Intellia Therapeutics, Inc. for certain human therapeutic applications. Additionally, Dr. Charpentier has licensed the technology to CRISPR Therapeutics AG and ERS Genomics Limited.

SOURCE University of California Office of the President

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University of California expands US CRISPR-Cas9 patent portfolio with issuance of new patent - PRNewswire

A scientific studypublished this past spring came with damning implications for Chinese scientist He Jiankui, who created the worlds first gene-edited babies: People with the rare genetic variants that Hetried to engineer into embryos, the study asserted, had an increaseddeath rate.

On [September 27], the papers senior author said his study was wrong.

The study centers around the effects of a variant of the gene known as CCR5, called 32, which is best known for protecting against infection with HIV, the virus that causes AIDS.

[Author Rasmus] Nielsen told STAT that the error stemmed from the specific single nucleotide polymorphism, or genetic marker, that he and [collaborator Xinzhu] Wei looked at. In the U.K. Biobank data, the marker they chose to work with had systematic errors related to genotype calling at that site in the DNA; thats the process by which the genotype is determined for each individual in the sample at each site.

The way the genotypes were being called caused certain genotypes to show up less frequently than they should have, Nielsen said, apparently generating the erroneous signal around increased mortality.

Read full, original post: Major error undermines study suggesting change introduced in the CRISPR babies experiment shortens lives

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Researcher backtracks on study suggesting He Jiankui's controversial CRISPR babies will have shorter lifespans - Genetic Literacy Project

XconomyBoston

A number of gene-editing companies have joined the public markets in recent years. Beam Therapeutics, which is developing a CRISPR-based technology intended to offer even more precise genomic edits, aims to become the latest one.

Cambridge, MA-based Beam filed its IPO paperwork with securities regulators late Friday. The company set a preliminary $100 million target for the offering. It has applied for a Nasdaq listing under the stock symbol BEAM.

CRISPR-Cas9 gene editing cuts the genome at specific locations in order to remove or add a piece of DNA. But Beam contends theres room to make CRISPR editing even more precise. If you picture the double helix structure of DNA as a ladder, each rung is made up of a base pair, which consists of two bases. Many genomic mutations occur in a single base. Beams technology, called base editing, is being developed to target these single base errors, which are called point mutations.

If existing gene editing approaches are scissors for the genome, our base editors are pencils, erasing and rewriting one letter in the gene, Beam says in its IPO prospectus.

Beam faces plenty of competition in the gene editing space. Other companies using CRISPR-Cas9 technology to develop new therapies include Caribou Biosciences, Editas Medicine (NASDAQ: EDIT), CRISPR Therapeutics (NASDAQ: CRSP), and Intellia Therapeutics (NASDAQ: NTLA). But the ability to edit point mutations could make the Beam technology applicable to a broader range of genetic diseases. The company says point mutations represent 58 percent of all known genetic errors associated with disease.

Beam was founded in 2017. Until now, Beam has kept quiet about which diseases it aims to treat. The companys filing lists 12 programs, including the blood disorders beta thalassemia and sickle cell disease, and the blood cancers acute lymphoblastic leukemia and acute myeloid leukemia. The pipeline also includes potential treatments for liver diseases, as well as disorders of the eye and the central nervous system.

All of Beams programs are preclinical. For most of them, the company says it has demonstrated therapeutically relevant base editing of cells in the lab. Next year, Beam aims to show that it can base edit genes in animals, tests that are slated for next year. If all goes well, Beam says it could start filing for clearance to begin human testing for multiple programs in 2021.

Beam has raised more than $223 million; its most recent financing was a $135 million Series B round in April. The company still has plenty of money in its coffers: As of June 30, Beam reported $126.8 million in cash holdings. The company says it will use the IPO proceeds to continue research and development of its base editing programs. According to the IPO filing, ARCH Venture partners is Beams largest shareholder with a 23 percent stake followed by F-Prime Capital Partners Healthcare Fund, which owns 19.4 percent of the company.

Heres more on the origins of Beam, which is based on research from Harvard University, the Broad Institute, and Massachusetts General Hospital.

Photo by Flickr user marco.savia a Creative Commons license

Frank Vinluan is editor of Xconomy Raleigh-Durham, based in Research Triangle Park. You can reach him at fvinluan [at] xconomy.com

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Beam Therapeutics Preps IPO and Sheds Light on Its Gene-Editing Drugs - Xconomy

CRISPR Therapeutics AG (CRSP):

If you are considering getting into the day trading or penny stock market, its a legitimate and profitable method for making a living. Every good investor knows that in order to make money on any investment, you must first understand all aspects of it, so lets look at daily change, stock price movement in some particular time frame, volatility update, performance indicators and technical analysis and analyst rating. Picking a stock is very difficult job. There are many factors to consider before choosing a right stock to invest in it. If picking stock was easy, everyone would be rich right? This piece of financial article provides a short snap of CRISPR Therapeutics AG (CRSP) regarding Monday trading session and presents some other indicators that can help you to support yours research about CRISPR Therapeutics AG (CRSP).

CRISPR Therapeutics AG (CRSP) stock Trading Summary:

CRISPR Therapeutics AG (CRSP) stock changed position at -3.23% to closing price of $40.99 in recent trading session. The last closing price represents the price at which the last trade occurred. The last price is also the price on which most charts are based; the chart updates with each change of the last price. The stock registered Monday volume of 435486 shares. Daily volume is the number of shares that are traded during one trading day. High volume is an indication that a stock is actively traded, and low volume is an indication that a stock is less actively traded. Some stocks tend always to have high volume, as they are popular among day traders and investors alike. Other stocks tend always to have low volume, and arent of particular interest to short-term traders. The stock average trading capacity stands with 459.2K shares and relative volume is now at 0.9.

CRISPR Therapeutics AG (CRSP) Stock Price Movement in past 50 Days period and 52-Week period

CRISPR Therapeutics AG (CRSP) stock demonstrated 84.47% move opposition to 12-month low and unveiled a move of -23.95% versus to 12-month high. The recent trading activity has given its price a change of -23.95% to its 50 Day High and -0.02% move versus to its 50 Day Low. Prices of commodities, securities and stocks fluctuate frequently, recording highest and lowest figures at different points of time in the market. A figure recorded as the highest/lowest price of the security, bond or stock over the period of past 52 weeks is generally referred to as its 52-week high/ low. It is an important parameter for investors (as they compare the current trading price of the stocks and bonds to the highest/lowest prices they have reached in the past 52 weeks) in making investment decisions. It also plays an important role in determination of the predicted future prices of the stock.

CRISPR Therapeutics AG (CRSP) Stock Past Performance

CRISPR Therapeutics AG (CRSP) stock revealed -12.30% return for the recent month and disclosed -14.09% return in 3-month period. The stock grabbed 15.63% return over last 6-months and -11.74% return in yearly time period. To measure stock performance since start of the year, it resulted a change of 43.47%. Past performance shows you the funds track record, but do remember that past performance is not an indication of future performance. Read the historical performance of the stock critically and make sure to take into account both long- and short-term performance. Past performance is just one piece of the puzzle when evaluating investments. Understanding how performance fits in with your overall investing strategy and what else should be considered can keep you from developing tunnel vision.

Volatility in Focus:

The stock unfolded volatility at 5.66% during a week and it has been swapped around 4.43% over a month. Volatility is a rate at which the price of a security increases or decreases for a given set of returns. Volatility is measured by calculating the standard deviation of the annualized returns over a given period of time. It shows the range to which the price of a security may increase or decrease. Volatility measures the risk of a security. It is used in option pricing formula to gauge the fluctuations in the returns of the underlying assets. Volatility indicates the pricing behavior of the security and helps estimate the fluctuations that may happen in a short period of time. If the prices of a security fluctuate rapidly in a short time span, it is termed to have high volatility. If the prices of a security fluctuate slowly in a longer time span, it is termed to have low volatility.

The average true range is a volatility indicator. This stocks Average True Range (ATR) is currently standing at 2.04.

Overbought and Oversold levels

The stock has RSI reading of 29.88. RSI gives an indication of the impending reversals or reaction in price of a security. RSI moves in the range of 0 and 100. So an RSI of 0 means that the stock price has fallen in all of the 14 trading days. Similarly, an RSI of 100 means that the stock price has risen in all of the 14 trading days. In technical analysis, an RSI of above 70 is considered an overbought area while an RSI of less than 30 is considered as an oversold area. RSI can be used as a leading indicator as it normally tops and bottoms ahead of the market, thereby indicating an imminent correction in the price of a security. It is pertinent to note that the levels of 70 and 30 needs to be adjusted according to the inherent volatility of the security in question.

Analyst Watch: Analysts have assigned their consensus opinion on this stock with rating of 2.3 on scale of 1 to 5. 1 or 2 =>Buy view 4 or 5 => Sell opinion. 3 =>Hold. Analysts recommendations are the fountainhead of equity research reports and should be used in tangent with proprietary research and investment methodologies in order to make investment decisions.

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Stock In Active Zone:: CRISPR Therapeutics AG (CRSP) - WEB NEWS OBSERVER

Franoise BaylisHarvard University Press2019297 pp.Purchase this item now

With Altered Inheritance, bioethicist Franoise Baylis has authored a vivid call to action that aims to bridge the divides between theory, science, politics, and practice in response to increased public awareness and scientific applications of CRISPR/Cas9 technology. She achieves her aim in this timely and important book.

Baylis calls for broad societal consensus and shared responsibility to guide heritable gene editing toward the common good, which she defines as that which is essential for survival and well-being, to which the market, property, and liberty are subordinate. Her call demands an urgent response, as she notes that humanity sits precipitously on the verge of either a new beginning or the beginning of the end.

A prologue and epilogue bookend the 10 chapters that comprise Altered Inheritance. The back matter includes an index to make the material accessible for scientifically curious general readers, scientists interested in the ethical dimensions of gene editing, and bioethicists seeking an innovative framework to direct theorizing and practice in the era of CRISPR.

Baylis seamlessly threads definitional and conceptual content into the first three chapters, which include critical information for readers who do not have a strong background in the terms and technology of gene editing. The first chapter analyzes Huntingtons disease as a case study for targeting a single gene. Chapter two distinguishes somatic from germline editingthe former being an edit that affects an individual, the latter being one that will be passed on to the individuals descendants. Heritable gene editing is the main focus of the book.

In chapter three, Baylis constructs a brief history of gene editing, using the case of designer babies as a central example. (Incidentally, the term designer baby was first coined to capture marketing-influenced, brand-heavy consumer behavior and only later came to be applied to gene editing.) She concludes this chapter with an expert philosophical discussion that shows that the demarcation between health-related editing and nonhealth-related editing is not as clear as our intuitions may lead us to believe. Cognitive enhancement through traditional means, including reading and education, may only be a difference of degree, not of kind, from gene editing that selects for particular cognitive traits.

Baylis continues this important discussion into chapter four, in which she argues that all medical treatments are a form of enhancementimproving or returning an aberrant gene to its normal status. However, not all enhancements, she argues, are treatments. If one accepts this premise, the pertinent ethical question is not whether treatments should be allowed and nonmedical enhancements prohibited but whether heritable gene editing of any stripe may be structured to promote equality, access, and fairness.

In chapter six, Baylis continues her discussion of the possible harms and benefits of germline editing through the lens of potential moral wrongs. She worries, for example, about the opportunity costs that could occur when science and technology funding is diverted toward gene editing research, the benefits of which may then only be accessible to those with economic means. Baylis encourages the public and scientists alike to ask first, how gene editing science will improve the human condition, and second, what kind of world they want to live in.

Baylis introduces the idea of impact ethics in chapter nine. Following a heuristic articulated in feminist ethics, in which one sets aside a traditional notion of individual autonomy, impact ethics advances a relational understanding of autonomy, viewing people as interdependent. Here, Baylis also resists the notion that experts have privileged access to the truth.

Decisions about the use of genetic technology are too important to be left to scientists, writes Baylis in chapter 10. This provocative claim is not intended as a negative account of scientists involvement in the gene editing debate nor as a prohibition on their ongoing work. Rather, it is meant as a call for bidirectional engagement between scientists and the public. Public empowerment in these integral policy discussions is something all of us may and should participate in.

Commitments to justice, responsibility, accountability, and consensus-building are features of a socially just science and bioethics. Toward this end, Altered Inheritance is a foundational tool in the path ahead.

The reviewer is a philosopher of science and freelance writer based in Indianapolis, IN, USA.

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A new book offers an introduction to the ethical dimensions of germline gene editing - Science Magazine

The race to build the cutting edge banana is on. The Colombian government affirmed a month ago that a banana-killing organism has attacked the Americas the wellspring of a great part of the worlds banana supply. The intrusion has given new earnestness to endeavors to make organic product that can withstand the scourge.

Researchers are utilizing a blend of ways to deal with spare the banana. A group in Australia has embedded a quality from wild bananas into the top business assortment known as the Cavendish and are right now testing these adjusted bananas in field preliminaries. Scientists are additionally going to the amazing, exact quality altering device CRISPR to support the Cavendishs flexibility against the growth, known as Fusarium wither tropical race 4 (TR4).

Reproducing TR4 opposition into the Cavendish utilizing ordinary techniques is absurd on the grounds that the assortment is sterile and proliferated by cloning. So the best way to spare the Cavendish might be to change its genome, says Randy Ploetz, a plant pathologist at the University of Florida in Homestead. The assortment represents 99% of worldwide banana shipments.

James Dale, a biotechnologist at Queensland University of Technology in Brisbane, Australia, began getting enquiries about his hereditarily altered (GM) bananas in July, as the primary gossipy tidbits surfaced that TR4 had arrived at Colombia. At that point Colombia pronounced a national crisis, Dale says, and now the measure of intrigue is through the rooftop.

This isnt the first occasion when that a business banana assortment has confronted eradication. In the main portion of the 1900s, another strain of the Fusarium parasite got TR1 almost cleared out the times head honcho, the Gros Michel. Be that as it may, ranchers had reinforcement in the Cavendish, which was impervious to TR1, intense enough to withstand taking care of during export and had an extensively adequate surface and taste. By the 1960s, enormous banana cultivators, for example, Chiquita, presently situated in Fort Lauderdale, Florida, were changing to the Cavendish.

Theres no simple elective this time. Rodomiro Ortiz, a plant geneticist at the Swedish University of Agricultural Sciences in Alnarp, says that no normally happening banana species has the characteristics that have made the Cavendish so well-known and the capacity to oppose TR4.

The U.S. Patent and Trademark Office (USPTO) has granted another patent to the University of California (UC), University of Vienna, and Dr. Emmanuelle Charpentier covering techniques for delivering a hereditarily altered cell through the presentation of the Cas9 protein, or

As the world restlessly screens the episode of Ebola in Democratic Republic of the Congo, wellbeing authorities note that a measles flare-up announced a month ago in the nation has killed more individualsfor the most part kidsand quicker. Since January

Among the numerous worldwide issues today, the battle against antimicrobial opposition (AMR) urgently needs a comparable leap forward responsibility. For promoters, AMR's appearance on the G20's plan a year ago, at the gathering's summit in Hangzhou, China, spoke to a

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CRISPR is the only hope against deadly funguses - BPhrm Dv

Formula One legend Michael Schumacher suffered life-changing head injuries in a skiing accident in 2013 and has since been receiving care at his home in Switzerland. It is believed the record-breaking racing driver cannot walk or stand and may have trouble communicating according to former Ferrari manager Jean Todt. So far Mr Schumachers treatment has been kept private, and nothing has been confirmed officially, however now the racing legend is under the care of world-renowned cardiac surgeon Philippe Menasch.

Mr Menasch is described as a pioneer in cell surgery at his hospital, Georges-Pompidou, in Paris.

According to the NHS: Stem cells are special cells produced by bone marrow (a spongy tissue found in the centre of some bones) that can turn into different types of blood cells.

The cells have been used since the 1980s to grow skin grafts for patients who have suffered life-threatening burns.

Read More:Michael Schumacher health update: Where is Michael Schumacher now?

They are also used in cancer treatments for cancers of the blood, and most recently have been used in repairing damage to the cornea - surface of the eye.

A lot about stem cells is still being discovered, with clinical trials taking place for illnesses and conditions like MS and macular degeneration, heart disease and spinal cord injuries.

The special cells are also being used in neurodegenerative diseases like Parkinsons and Alzheimers and traumatic brain injuries like Mr Schumachers.

In an interview online, Mr Menasch explained stem cell treatment for cardiac conditions is only touching the surface.

Read More:Michael Schumacher could be able to cry and move his thumbs'

He said: Nobody really knows how stem cells are working.

They do not permanently transplant into the myocardium, the muscular tissue of the heart after a couple of days or weeks they just disappear.

Mr Schumacher received stem cell therapy in September in Paris, however, not much information has surfaced about the procedure.

MrMenasch spoke to Italian newspaper La Repubblica and said: There was an explosion in the attention our department received but the situation has already normalised.

Local media dubbed the procedure experimental however MrMenasch denied this saying: everyone is looking for me but I have not used experimental cures.

I do not perform miracles. My team and I are not doing an experiment, an abominable term that is not in line with a serious medical view.

Michael Schumacher is motor racings most successful driver, with a record 91 Grand Prix wins.

He won his first titles with Benetton in 1994 and 1995 followed by five in a row with Ferrari between 2000-2004.

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Michael Schumacher health latest: What is stem cell therapy and how will it help Schumi? - Express.co.uk

The global stem cell therapy market growth has been primarily attributed to the major drivers in this market such as the increasing prevalence of chronic diseases, rising number of clinical trials for cell-based therapy, steady investment, and consolidation in the regenerative medicine market, and favorable regulatory environment.

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Key Players in the Stem Cell Therapy Market are:

Market Definition: Stem Cell Therapy Market

Stem cells are human cells that have the ability to develop into various cell types such as muscle cells, brain cells they also have the unique ability to repair damaged tissue. Stem cells are divided into two major categories namely: embryonic stem cells and adult stem cells. The embryonic stem cell that is being used to conduct research today came from unused embryos resulting from an in vitro fertilization process which were later donated to science. These embryonic stem cells are pluripotent this basically means that they can turn into more than one type of cell. There are two types of adult stem cells- one of the type comes from fully developed tissues, such as the brain, the skin, and even bone marrow. The second type is induced pluripotent stem cells. These are adult stem cells that have been manipulated in a laboratory to take on characteristic of embryonic stem cells which enables them to turn into more than one type of cell.

The worldwide Stem Cell Therapy Market report give point by point data about the Stem Cell Therapy Market with a fitting examination of a few parameters and patterns impacting its advancement at a worldwide premise.

Scope of the Market :

The stem cell therapy market research provides a holistic view of the stem cell therapy market in terms of various factors influencing it, including regulatory reforms, and technological advancements.

The scope of this report is centered upon conducting a detailed study of the products allied with the therapeutic application of stem cells. In addition, the study also includes exhaustive information on the unmet needs, perception on the new products, competitive landscape, market share of leading manufacturers, the growth potential of each underlying sub-segment, and company, as well as other vital information with respect to global stem cell therapy market.

Market Segmentation

Market drivers: Stem Cell Therapy Market

Market Restraints: Stem Cell Therapy Market

Key Developments: CRISPR Technology Market

Stem cell therapy is accelerating at a huge growth circle that promises a potential for diversified career opportunities.

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Table of Contents

INTRODUCTION

RESEARCH METHODOLOGY

In light of the examination of affecting development and constraining parameters, the exact information showing the future development pattern of the market can be gotten, which is altogether clarified in the Stem Cell Therapy Market research report. The data with respect to the moving toward circumstances that can help the market capitalization is additionally incorporated into the report. The report likewise involves fundamental data, for example, yearly income age, advertise esteem, use, yearly deals, and other significant measurable information, with respect to the key market contenders which incorporate a few associations, firms, item makers, sellers, and wholesalers.

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Global Stem Cell Therapy Market Report, 2019-2030 : Focus on Treatment Type, Cell Source, Indication and Competitive Landscape - Space Market Research

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), will today announce positive results from a single-arm cohort of the Phase II/III Blood First Assay Screening Trial (BFAST), the first prospective study to use only blood-based next generation sequencing (NGS) to detect specific fusions with the aim of selecting treatment for people with advanced non-small cell lung cancer (NSCLC), without the need for tissue biopsy. Results from the anaplastic lymphoma kinase (ALK) cohort will be presented at the European Society for Medical Oncology (ESMO) 2019 Congress on Monday, September 30 from 9:15 9:30 a.m. CEST (Abstract LBA81 PR) and were also part of the official ESMO press program.

Obtaining tumor tissue for biomarker testing can be a challenge in many people with cancer and, as a result, some may not receive optimal treatment for their disease, said Sandra Horning, M.D., chief medical officer and head of Global Product Development. BFAST is the first trial to show that by using a blood-based next-generation diagnostic, it is possible to identify the ALK mutation in people with non-small cell lung cancer using a blood draw alone, which means that more people could potentially benefit from Alecensa.

Foundation Medicine is pleased to partner with Roche on this study, a first-of-its-kind, pivotal trial that directly demonstrates the clinical utility of using our comprehensive blood-based assay, FoundationOne Liquid, to detect specific fusions and match NSCLC patients with first-line treatment, said Brian Alexander, M.D., chief medical officer of Foundation Medicine. Validated and comprehensive liquid biopsy tests are critical to help physicians find the best possible treatment approach for patients with advanced cancer and for whom tissue testing isnt feasible. Identifying ALK fusions can be particularly challenging and these data demonstrate that FoundationOne Liquid can accurately predict which patients can respond to therapy.

The BFAST study used FoundationOne Liquid, Foundation Medicines comprehensive liquid biopsy test, which detects the four main classes of genomic alterations, microsatellite instability (MSI) and select fusions including ALK in circulating tumor DNA (ctDNA) from a blood draw. These data demonstrate that the FoundationOne Liquid assay can help to test and identify a broader population of people with advanced NSCLC who may benefit from Alecensa, for whom current diagnostic tests are not suitable, such as for those who cannot provide tissue samples due to insufficient or absent tumor tissue, or where tissue diagnostics are not available, and validate the clinical utility of blood-based NGS as an additional method to inform clinical decision-making in ALK-positive NSCLC.

In the study, 87.4% (95% CI: 78.5-93.5) of people with advanced NSCLC who were identified by the FoundationOne Liquid biopsy assay to have ALK fusions had a confirmed response to treatment with Alecensa (overall response rate; ORR) as measured by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST v1.1). This is consistent with the ORR for Alecensa observed in the pivotal Phase III ALEX trial, which identified people using tissue-based testing. When measured using an Independent Review Facility per RECIST v1.1, the confirmed ORR was numerically higher at 92.0% (95% CI: 84.1-96.7). Median progression free-survival (PFS) and duration of response (DoR) were not reached after a median follow-up of 12.6 months. The safety profile of Alecensa was consistent with prior clinical trials and post-marketing experience, with no new safety signals observed.

About the BFAST study

BFAST (Blood First Assay Screening Trial) (NCT03178552) is a Phase II/III global, multi-center, open-label, multi-cohort study evaluating the safety and efficacy of targeted therapies or immunotherapies as single agents or in combination in people with unresectable, advanced or metastatic NSCLC determined to harbor oncogenic somatic mutations or be tumor mutational burden (TMB)-positive as identified by blood-based NGS ctDNA assays. The Alecensa ALK-positive cohort is the first to readout, with other cohorts due to follow. The primary endpoint for the Alecensa ALK-positive cohort of the BFAST study is confirmed investigator (INV)-assessed ORR. Secondary endpoints include: independent review facility (IRF)-assessed ORR, DoR (INV and IRF), PFS (INV and IRF), overall survival (OS) and safety.

About lung cancer

According to the American Cancer Society, it is estimated that more than 228,000 Americans will be diagnosed with lung cancer in 2019, and NSCLC accounts for 80-85% of all lung cancers. It is estimated that approximately 60% of lung cancer diagnoses in the United States are made when the disease is in the advanced stages.

About Alecensa (alectinib)

Alecensa is a kinase inhibitor approved for the treatment of people with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.

Alecensa U.S. Indication

Alecensa is a kinase inhibitor approved for the treatment of people with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.

Important Safety Information

Everyone reacts differently to treatment with Alecensa. Its important to know the most serious and most common side effects with Alecensa.

A doctor may lower the dose or stop treatment with Alecensa if any serious side effects occur. Patients taking Alecensa should contact their doctor right away if they have any of the following side effects.

Alecensa may cause serious side effects, including:

Liver problems (hepatotoxicity). Alecensa may cause liver injury. A doctor will do blood tests at least every 2 weeks for the first 3 months and as needed during treatment with Alecensa. Patients taking Alecensa should tell their doctor right away if they experience any of the following signs and symptoms:

Lung problems. Alecensa may cause severe or life-threatening swelling (inflammation) of the lungs during treatment. Symptoms may be similar to those symptoms from lung cancer. Patients taking Alecensa should tell their doctor right away if they have any new or worsening symptoms, including:

Kidney problems. Alecensa may cause severe or life-threatening kidney problems. Tell your healthcare provider right away if you have a change in the amount or color of your urine, or if you get new or worsening swelling in your legs or feet.

Slow heartbeat (bradycardia). Alecensa may cause very slow heartbeats that can be severe. A doctor will check a patients heart rate and blood pressure during treatment with Alecensa. Patients taking Alecensa should tell their doctor right away if they feel dizzy, lightheaded, or faint during treatment with Alecensa. Patients taking Alecensa should tell their doctor if they take any heart or blood pressure medicines.

Muscle pain, tenderness, and weakness (myalgia). Muscle problems are common with Alecensa and can be severe. A doctor will do blood tests at least every 2 weeks for the first month and as needed during treatment with Alecensa. Patients taking Alecensa should tell their doctor right away if they have any new or worsening signs and symptoms of muscle problems, including unexplained muscle pain or muscle pain that does not go away, tenderness, or weakness.

Before taking Alecensa, patients should tell their doctor about all medical conditions, including if they:

Patients taking Alecensa should tell their doctor about all the medicines they take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements.

Patients taking Alecensa should avoid spending time in the sunlight during treatment with Alecensa and for seven days after the final dose of Alecensa. Patients taking Alecensa may burn more easily and get severe sunburns. Patients taking Alecensa should use sunscreen and lip balm with a SPF 50 or greater to help protect against sunburn.

The most common side effects of Alecensa include:

These are not all of the possible side effects of Alecensa. For more information, patients should ask their doctor or pharmacist. Patients should call their doctor for medical advice about side effects.

Report side effects to the FDA at (800) FDA-1088 or http://www.fda.gov/medwatch. Patients and caregivers may also report side effects to Genentech at (888) 835-2555.

Please see additional Important Safety Information in full Prescribing Information, including Patient Information.

About Foundation Medicine

Foundation Medicine is a molecular information company dedicated to a transformation in cancer care in which treatment is informed by a deep understanding of the genomic changes that contribute to each patient's unique cancer. The company, a member of the Roche Group, offers a full suite of comprehensive genomic profiling tests to identify the molecular alterations in a patient's cancer and match them with relevant targeted therapies, immunotherapies and clinical trials. Foundation Medicines molecular information platform aims to improve day-to-day care for patients by serving the needs of clinicians, academic researchers and drug developers to help advance the science of molecular medicine in cancer.

For more information, please visit http://www.foundationmedicine.com or follow Foundation Medicine on Twitter (@FoundationMedicineATCG).

About Genentech in Lung Cancer

Lung cancer is a major area of focus and investment for Genentech, and we are committed to developing new approaches, medicines and tests that can help people with this deadly disease. Our goal is to provide an effective treatment option for every person diagnosed with lung cancer. We currently have five approved medicines to treat certain kinds of lung cancer and more than 10 medicines being developed to target the most common genetic drivers of lung cancer or to boost the immune system to combat the disease.

About Genentech

Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.

Excerpt from:
Genentech to Present Results of First Prospective Trial Using Blood-based Next Generation Sequencing Which Successfully Identifies People for...

By Brandon Showalter, CP Reporter | Thursday, September 26, 2019 Lupron, puberty blocker and prostate cancer drug.

Drugs that are being used to halt puberty in gender-confused youth have been linked to thousands of adult deaths, government data show.

The Food & Drug Administration has recorded thousands of deaths associated with Lupron, a puberty-blocking drug that is routinely used to treat prostate cancer in men and endometriosis in women. Adverse complications related to its use include breast disorders, malignant neoplasms, and psychiatric and nervous disorders.

Lupron and other drugs in its class significantly alters the hormone levels in the body and has been documented to contribute to blood clots and other cardiovascular complications, as well as brittle bones and faulty joints.

Between 2004 and June 30 of this year, the FDA documented33,478 adverse reactionssuffered by patients who took Leuprolide Acetate (Lupron), which is used as a hormone blocker. More than 19,054 reactions were considered "serious," including 6,056 deaths.

The figure rises when factoring in the total number of adverse reactions logged by the FDA since 1984. In total, there have been 40,764 adverse reactions, 25,513 of those were considered "serious," among those were 6,370 deaths.

Lupron is being prescribed off-label for use in children who have been diagnosed with gender dysphoria despite the lack of formal FDA approval for that purpose. The drug is clinically approved for treatment of precocious puberty, a condition where children start their pubertal processes at an abnormally early age and the blocker is administered for a short time until the proper age.

"The first well-documented case report of a puberty blocker like Lupron (a similar medication called Triptorelin which has an identical mechanism of action) being used in a young patient with gender confusion was published out of Holland in 1998 where a pediatric endocrinologist, working together with a psychiatrist, decided to use the medication on a 13-year-old girl suffering from gender dysphoria,"Michael Laidlaw, a Rocklin, California-based endocrinologist, told The Christian Postin a previous interview.

Reports have emerged in recent years showing that the pediatric version of the drug comes with few warnings about long-term side effects and leads to lasting and severe health problems.

When injected into a physically healthy body, the drug interrupts a normally-functioning endocrine system, yielding hypogonadotropic hypogonadism, according to Laidlaw.

Its a serious condition that endocrinologists would normally diagnose and treat because it interferes with development, but in [gender dysphoria] cases theyre inducing this disease state, he said in aninterviewwith the National Catholic Register.

In 2017, the FDA said it was "conducting a specific review of nervous system and psychiatric events in association with the use of GnRH agonists, [a class of drugs] including Lupron, in pediatric patients, in response to questions from Kaiser Health News and Reveal from the Center for Investigative Reporting. The government agency was also reportedly reviewing seizures that stemmed from use of Lupron's pediatric version and other drugs in its class.

Transgender activists often promote such drugs as a "pause button" on life, giving young people additional time to decide whether to proceed to cross-sex hormones and surgical transition.

The therapeutic idea behind the use of Lupron for treatment of prostate cancer is that by inhibiting the flow of testosterone over the prostate and reducing it to a low, undetectable level, prostate cancer tissue is prevented from growing, Laidlaw told CPin a previousinterview about the drug's dangers.

Unlike prostate cancer, a disease where the drug at least serves the purpose of targeting the malignant masses on the organ, Laidlaw said he knows of no psychological condition that is treated by putting hormones out of alignment from their normal levels.

"Gender dysphoria is not an endocrine condition, but is a psychological one and should, therefore, be treated with proper psychological care. But it becomes an endocrine condition once you start using puberty blockers and giving cross-sex hormones to kids," Laidlaw stressed at the time.

According to the annual report of AbbVie, the company that produces Lupron, sales of the drug were approximately $669 million in 2017 in the United States alone.

England's lone gender clinic, the Tavistock Centre in London, has come under scrutiny in recent months in part because of intensifying public concern about puberty blockers.

Kirsty Entwistle, who until last October was a staff psychologist at the Gender Identity Development Service in Leeds, accused Tavistock clinicians in July of misleading young patients, saying they were making decisions that will have a major impact on children and young peoples bodies and lives ... without a robust evidence base" and said the facility had troubling internal practices.

Children and their families were being told that puberty-suppressing drugs used to transition youth were "fully reversible," when in fact the drugs' long-term effects remain unknown, she said, noting that an "unspoken rule" existed within the clinic that clinicians were never to inform families that their children were not transgender.

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Drugs used as puberty blockers in youth linked to thousands of adult deaths, FDA shows - The Christian Post

AMA Research added a comprehensive research document of 200+ pages on Testosterone Replacement Therapy market with detailed insights on growth factors and strategies. The study segments key regions that includes North America, Europe, Asia-Pacific with country level break-up and provide volume* and value related cross segmented information by each country. Some of the important players from a wide list of coverage used under bottom-up approach are

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Testosterone is responsible for the development of male sexual characteristics and this hormone formed by the testicles. Insufficient production of testosterone causes erectile dysfunction. Testosterone Replacement Therapy (TRT) is generally termed as hormone therapy for men, designed to counteract the effects of reduced activity in the gonads or hypogonadism. Hypogonadism in men is clinical syndrome, which results in the failure of the testes to produce physiological levels of testosterone. Erectile dysfunction arises due to reduce testosterone production to overcome this testosterone replacement therapy is used to improve the problem.

Market Segmentation

by Type (Creams or Gels, Patches, Injections, Buccal Adhesives, Implants, Oral), Application (Hospitals, Clinics) Market Concentration Insights:

CR4, CR8 and HHI Index Analysis

Comparative Market Share Analysis (Y-o-Y)

Major Companies Market Position and Development Strategy

Emerging Players Heat Map Analysis

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Highlights of Influencing Trends: Increasing awareness about testosterone substitute therapy

Market Growth Drivers: Increasing prevalence of hypogonadism in adult men

The need for having an offspring amongst men

Restraints: High possibility of side effects related to testosterone replacement therapy

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Country level Break-up includes:

North America (United States, Canada and Mexico)

Europe (Germany, France, United Kingdom, Spain, Italy, Netherlands, Switzerland, Nordic, Others)

Asia-Pacific (Japan, China, Australia, India, Taiwan, South Korea, Middle East & Africa, Others)

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Get full copy of United States Testosterone Replacement Therapy Market Study @ USD 2000

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Highlights from Table of Content (TOC):

1 Report Overview

1.1 Study Scope

1.2 Key Market Segments

1.3 Players Covered

1.4 Market Analysis by Type

1.5 Market by Application

1.6 Study Objectives

1.7 Years Considered

2 Global Growth Trends

2.1 Global Testosterone Replacement Therapy Market Size

2.2 Testosterone Replacement Therapy Growth Trends by Regions

2.3 Industry Trends

3 Market Share by Key Players

3.1 Global Testosterone Replacement Therapy Market Size by Manufacturers

3.2 Global Testosterone Replacement Therapy Key Players Head office and Area Served

3.3 Key Players Product/Solution/Service

3.4 Enter barriers in Testosterone Replacement Therapy Market

3.5 Mergers, Acquisitions, Expansion Plans

4 Testosterone Replacement Therapy Market by Product

4.1 Global Testosterone Replacement Therapy Sales by Product

4.2 Global Testosterone Replacement Therapy Revenue by Product

4.3 Global Testosterone Replacement Therapy Price by Product

5 Testosterone Replacement Therapy Market by End User

5.1 Overview

5.2 Testosterone Replacement Therapy by End User

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Testosterone Replacement Therapy Market: A Straight Overview of Growing Market & Future Trend by 2024 - Research Newscast