Archive for October, 2020

Staff Writer| Lubbock Avalanche-Journal

By Elizabeth Herbert

A-J Media

A 16-year-old Lubbockite with rheumatoid arthritis recently banked her wisdom teeth for their high concentration of stem cells in the hope of using them in a future procedure.

Stem cells are undifferentiated cells, meaning they can become almost any specialized cell; researchers have been studying these cells to learn more about using them to treat ailments such as rheumatoid arthritis.

The oral and facial surgeon who removed the patients teeth, Dr. Robert Ioppolo, said there was virtually no downside to storing the teeth and cells because the procedure, which is necessary for most, is the same for the patient regardless.

Instead of putting (wisdom teeth) in a baggie, we put them in a vial; we put them in a little freezer-type cryopreservation box and off they go to the processing center, he said, so its very straightforward from our perspective, and it just provides an additional service to patients that we didnt have access to a few years ago.

Once the teeth have been sent to process at the Stemodontics lab, Ioppolo said specialists open the teeth and extrapolate the nerve tissue to obtain the stem cells.

The cool thing is that the stem cell population inside of wisdom teeth, especially in somebody thats young and healthy, is at its peak as far as the amount of cells, so the quantity, and also the quality of those cells, he said, so this is kind of a one-time opportunity that folks have to bank the best stem cells that they possibly can from their wisdom teeth.

Rheumatoid arthritis typically impacts adults. The Centers for Disease Control states 7.1% of people aged 18-44 years old report being diagnosed with arthritis; younger groups are not listed on the main, arthritis-related page.

Jamie Fields, the patients mother, said her daughter has undergone knee surgeries and is on medications but has not seen strong improvements in the seven months she has been receiving treatment.

Doctors tried a technique called microfracture in which tiny holes are drilled into the knee to produce new tissue, but this results in fibrocartilage and is more like scar tissue and less like the cushiony cartilage that joints need to function properly, according to an article from the Stanford Medicine News Center.

Preserving her daughters wisdom teeth and stem cells will cost Fields $2,000, but she said her alternative is to grow cells from the cartilage taken from a previous surgery which would cost about $46,000 for the graft alone and does not account for an accompanying procedure.

When I hear about these stem cells, Im like, Well, what if this would work, she said. If thats the route we have to take, then why not try this first?

Aside from surgeries, Fields said her daughters doctor prescribed medications to help slow or stop the dying cartilage behind her knee. There are many options, but medicines tend to have side effects and Fields said she does not want her daughter to have to use multiple, strong pharmaceuticals long-term.

He has a list, and he started her at the bottom of the list on the medications, and then he said we would just go up from there, but that way we dont do anything too harsh thats not needed, she said.

Rheumatoid arthritis tends to worsen with age, and Fields said her daughter, who already has a history of broken bones and surgeries, is impacted by her rheumatoid arthritis to the extent that she cannot participate in gymnastics, cheerleading or other fun activities she has enjoyed.

Fields could keep working down the line of medications most 16 year olds cannot pronounce, or she said she could save her daughters stem cells and wait for orthopedists to create a procedure that would use her daughters cells to help rejuvenate damaged areas.

This is a once-in-a-lifetime (opportunity), Fields said. If we dont do this now, where is she gonna get them from later, of her own?

Michael Longaker, Deane P. and Louise Mitchell Professor for the Department of Surgery and Co-Director for the Institute of Stem Cell Research and Regenerative Medicine at Stanford University, said using stem cells could help a number of issues due to the cells ability to change.

While we do some things really well, like cardiac bypass surgery or hip replacement et cetera, et cetera, itd be great if we could unlock the power of cells that can become other types of cells so that we could regenerate each of these things before they get to the point where they need a major operation, he said.

Stem cells can be found throughout the body, and removing wisdom teeth is a fairly routine procedure; the WebMD website states over 10 million wisdom teeth are removed annually.

Many of these teeth are disposed of, but Longaker pointed out that stem cells in wisdom teeth are unique to the individual and are great sources of stem cells.

In the soft part, the pulp, of those teeth are stem cells that - God forbid - that healthy, young patient whos having them removed, God forbid anything happens to them and they need something or they have a family history of disease - theyre all set and ready to go, he said.

Longakers teams research began with mice and found skeletal stem cells can be manipulated to become cartilage.

They used two major molecules, bone morphogenetic protein 2 and vascular endothelial growth factor, to help the cells start bone formation after microfracture yet stop the process halfway to create cartilage. Longaker said the next step in the research is to focus on larger animals; then human clinical trials can begin.

Stem cells from wisdom teeth would work best for things in the mouth such as bone and cartilage, but Longaker said the cells can be backed up, de-differentiated and guided in a dish to the point where the cell can become almost anything; once the cell is fully differentiated, or has changed into a specific type of cell the specialist intended, it can be implanted.

You take the stem cells from teeth and back them up, so to speak, so they can become almost any type of cell, and then you would guide them down the exit ramp, so to speak, to where you want them to go, he said.

It may be years before orthopedists use stem cells to improve arthritic conditions, but Longaker, who banked his own sons wisdom teeth, said advances happen regularly and that one never knows when their stem cells will be useful.

As a stem cell biologist, having someone already store stem cells that I could guide to become something else, God forbid they need it, that really makes sense to me, he said. I dont see a reason not to do it if a parent or patient wants to do it.

Although banking her daughters wisdom teeth will not yield immediate results, Fields said she believes god guided her on this path and that she has more to gain than to lose.

Our faith is really strong, and I believe that God has led us on this path to hopefully find something that we can do to help her because weve been on this path for so long and with no answers, she said.

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Banking wisdom: Teen saving stem cells in hopes of future treatment - LubbockOnline.com

DUBLIN--(BUSINESS WIRE)--The "Cell Based Assay & High Content Screening Markets Market Forecasts by Application, With Executive and Consultant Guides and including Customized Forecasting and Analysis 2020 to 2024" report has been added to ResearchAndMarkets.com's offering.

This updated report will bring the entire management team up to speed, on both the technology and the opportunity.

Cell Based Assays are a mainstay of drug development and scientific research, but growth is now accelerating as new immuno-oncology markets create unprecedented investment in the race to cure cancer. On top of this new technology is allowing Cell Based Assays to be used to measure any aspect of cell function. This market just keeps on growing with no end in sight. The workhorse of the pharmaceutical industry is becoming a central player in biotechnology.

The technology is moving faster than the market. Genomics and Immunology are playing a role too. Find opportunities and pitfalls. Understand growth expectations and the ultimate potential market size.

Key Topics Covered:

1. Introduction and Market Definition

1.1 What are Cell Based Assays?

1.2 Clinical Trial Failures

1.2.1 Immuno-oncology Plays a Leading Role in Cell Based Assays

1.3 Market Definition

1.4 Methodology

1.5 U.S. Medical Market and Pharmaceutical Research Spending - Perspective

1.5.1 U.S. Expenditures for Pharmaceutical Research

2. Cell Based Assays - Guide to Technology

2.1 Cell Cultures

2.1.1 Cell Lines

2.1.2 Primary Cells

2.1.3 Stem Cells

2.1.3.1 iPSC's - The Special Case

2.2 Cell Assays

2.3 Cell Viability Assays

2.3 Cell Proliferation Assays

2.4 Cytotoxicity Assays

2.5 Cell Senescence Assays

2.6 Apoptosis

2.7 Autophagy

2.8 Necrosis

2.9 Oxidative Stress

2.10 2D vs. 3D

2.11 Signalling Pathways, GPCR

2.12 Immune Regulation & Inhibition

2.13 Reporter Gene Technology

2.14 CBA Design & Development

2.15 Cell Based Assays - The Takeaway

3. Industry Overview

3.1 Players in a Dynamic Market

3.1.1 Academic Research Lab

3.1.2 Contract Research Organization

3.1.3 Genomic Instrumentation Supplier

3.1.5 Cell Line and Reagent Supplier

3.1.6 Pharmaceutical Company

3.1.7 Audit Body

3.1.8 Certification Body

4. Market Trends

4.1 Factors Driving Growth

4.1.1 Candidate Growth

4.1.2 Immuno-oncology

4.1.3 Genomic Blizzard

4.1.4 Technology Convergence

4.1.5 The Insurance Effect

4.2 Factors Limiting Growth

4.2.1 CBA Development Challenges

4.2.2 Instrument Integration

4.2.3 Protocols

4.3 Technology Development

4.3.1 3D Assays

4.3.2 Automation

4.3.3 Software

4.3.4 Primary Cells

4.3.5 Signalling and Reporter Genes

4.3.6 The Next Five Years

5. Cell Based Assays Recent Developments

5.1 Recent Developments - Importance and How to Use This Section

5.1.1 Importance of These Developments

5.1.2 How to Use This Section

6. Profiles of Key Cell Based Assay Companies

7. Global Market Size

8. Global Market by User Type

8.1 Pharmaceutical Market

8.2 Basic Research Market

8.3 Industrial/Cosmetic Market

9. Cell Based Assay by Product Class

9.1 Instrument Market

9.2 Reagent Market

9.3 Services Market

9.4 Software Market

10. Appendices

10.1 FDA Cancer Drug Approvals by Year

10.2 Clinical Trials Started 2010 to 2016

10.3 Share of Pharma R&D by Country

For more information about this report visit https://www.researchandmarkets.com/r/1vziyy

Follow this link:
Global Cell Based Assay & High Content Screening Markets to 2024: Updated Report - Understand Growth Expectations and the Potential Market Size -...

KENILWORTH, N.J.--(BUSINESS WIRE)--Oct 16, 2020--

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced positive results from two studies from the companys leading lung cancer clinical development program evaluating KEYTRUDA, Mercks anti-PD-1 therapy: KEYTRUDA in combination with chemotherapy (KEYNOTE-021 [Cohort G]) and KEYTRUDA in combination with quavonlimab (MK-1308), Mercks novel investigational anti-CTLA-4 antibody.

In KEYNOTE-021 (Cohort G), first-line treatment with KEYTRUDA in combination with chemotherapy (n=60) demonstrated a significant improvement in objective response rates (58% vs. 33%), progression-free survival (HR=0.54 [95% CI, 0.35-0.83]) and a sustained, long-term survival benefit (HR=0.71 [95% CI, 0.45-1.12]) versus chemotherapy alone (n=63) in patients with advanced nonsquamous non-small cell lung cancer (NSCLC) regardless of PDL1 expression (Featured Poster #OFP01.02). Patients in Cohort G had no EGFR or ALK genomic tumor aberrations. These findings represent the longest follow-up data for an anti-PD-1/PDL1 therapy in combination with chemotherapy for the first-line treatment of NSCLC. Additionally, updated follow-up data from a Phase 1/2 study of quavonlimab in combination with KEYTRUDA showed encouraging anti-tumor activity and an acceptable safety profile as first-line treatment in patients with advanced NSCLC (Poster #TS01.02).

Over the last five years, KEYTRUDA has become foundational in the treatment of metastatic lung cancer. The long-term data from KEYNOTE-021 (Cohort G) reinforce the use of KEYTRUDA in combination with chemotherapy in certain advanced lung cancer patients, while data from our oncology pipeline reflect our commitment to exploring a number of new combinations with KEYTRUDA that we believe could have a meaningful impact for more lung cancer patients, said Dr. Vicki Goodman, vice president, oncology clinical research, Merck Research Laboratories. Updated data from our anti-CTLA-4 antibody quavonlimab in combination with KEYTRUDA support the continued development of this new combination and a Phase 3 study of quavonlimab coformulated with KEYTRUDA in advanced non-small cell lung cancer is planned.

Results from both studies were presented at the IASLC 2020 North America Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer on Friday, Oct. 16. Follow Merck on Twitter via @Merck and keep up to date with NACLC news and updates by using the hashtag #NACLC20.

KEYTRUDA in Combination With Chemotherapy: Long-Term Data in Advanced NSCLC From KEYNOTE-021 (Cohort G) (Featured Poster #OFP01.02)

New data from Cohort G of KEYNOTE-021 ( NCT02039674 ) demonstrated a significant improvement in objective response rates (ORR), progression-free survival (PFS) and a sustained, long-term survival benefit with KEYTRUDA in combination with pemetrexed (ALIMTA ) and platinum chemotherapy versus pemetrexed and platinum chemotherapy alone after four years of median study follow-up (49.4 months; range, 43.5 to 55.4). Cohort G of the Phase 1/2, multi-cohort, multi-center, open-label trial evaluated KEYTRUDA in combination with chemotherapy (n=60) versus chemotherapy alone (n=63) as first-line treatment in patients with advanced nonsquamous NSCLC. Patients in Cohort G had no EGFR or ALK genomic tumor aberrations.

Findings from KEYNOTE-021 (Cohort G) showed that 50% of patients treated with KEYTRUDA in combination with chemotherapy were alive at three years versus 37% of patients who received chemotherapy alone. KEYTRUDA in combination with chemotherapy also reduced the risk of death by 29% (HR=0.71 [95% CI, 0.45-1.12]) versus chemotherapy alone, with a median overall survival (OS) of 34.5 versus 21.1 months. The OS benefit was observed despite a 70% (n=43/61) effective crossover rate from chemotherapy to antiPD1/PDL1 therapy, including 28 patients who were treated with KEYTRUDA as part of the on-study crossover.

The ORR was 58% for KEYTRUDA in combination with chemotherapy versus 33% for chemotherapy alone. KEYTRUDA also reduced the risk of disease progression or death by 46% (HR=0.54 [95% CI, 0.35-0.83]) versus chemotherapy, with a median PFS of 24.5 months (range, 9.7 to 36.3) versus 9.9 months (range, 6.2 to 15.2). The estimated three-year PFS rate was 37% for patients who received KEYTRUDA in combination with chemotherapy versus 16% for those who received chemotherapy alone. The median duration of response (DOR) was more than one year longer with KEYTRUDA in combination with chemotherapy (36.3 months; range, 1.4+ to 49.3+) versus chemotherapy alone (22.8 months; range, 2.8+ to 47.2+). Additionally, 51% of patients treated with KEYTRUDA in combination with chemotherapy had responses lasting three years versus 47% with chemotherapy alone.

Notably, 92% of patients who completed two years of treatment with KEYTRUDA were alive at three years (n=11/12). All 12 patients experienced an objective response and the estimated three-year DOR rate was 100% (median DOR not reached [NR]; range, 11.7+ to 49.3+ months).

No new safety signals for KEYTRUDA in combination with chemotherapy were identified with long-term follow-up. Among all those treated, 39% of those who received KEYTRUDA in combination with chemotherapy and 31% of those who received chemotherapy alone experienced Grade 3-5 treatment-related adverse events (TRAEs). Grade 3-5 TRAEs that led to discontinuation occurred in 17% of patients who received KEYTRUDA in combination with chemotherapy and 16% of those who received chemotherapy alone. Grade 3-5 TRAEs that led to death occurred in 2% (n=1) of patients who received KEYTRUDA in combination with chemotherapy and 3% (n=2) of those who received chemotherapy alone.

The KEYNOTE-021 (Cohort G) trial was conducted in collaboration with Eli Lilly and Company, the makers of pemetrexed (ALIMTA ).

Quavonlimab (anti-CLTA-4) in Combination With KEYTRUDA: Phase 1/2 Results in Advanced NSCLC (Poster #TS01.02)

In this first-in-human, open-label, multi-arm Phase 1/2 study ( NCT03179436 ), quavonlimab, Mercks novel anti-CTLA-4 therapy, was evaluated in combination with KEYTRUDA as a first-line treatment in patients with advanced NSCLC. In the dose-confirmation phase, patients received quavonlimab (25 mg or 75 mg) every three weeks (Q3W) or every six weeks (Q6W) in combination with KEYTRUDA (200 mg Q3W for up to 35 cycles). The primary objective of the study was safety and tolerability; secondary and exploratory objectives included ORR per RECIST v1.1 by blinded independent central review (BICR), PFS, OS and DOR. Response based on PD-L1 status was retrospectively evaluated using tumor proportion score (TPS) as a continuous variable.

Findings showed that quavonlimab in combination with KEYTRUDA had an acceptable safety profile with no unexpected toxicities and suggested encouraging anti-tumor activity. Any-grade adverse events occurred in 98% of patients; TRAEs occurred 85% of patients. Grade 3 TRAEs occurred in 36% of patients across all treatment arms and the most common TRAEs ( > 10% in any arm) were increased alanine aminotransferase (8%), pneumonitis (8%) and increased aspartate aminotransferase (6%).

With 16.9 months of median follow-up (range, 7.0 to 21.3), results from the study showed the effect of quavonlimab in combination with KEYTRUDA across secondary and exploratory endpoints, including ORR, PFS, OS and DOR. Responses to quavonlimab in combination with KEYTRUDA were observed regardless of PD-L1 expression with higher TPS scores significantly associated with better response (one-sided p=0.015). These safety and efficacy data support the 25 mg Q6W dose as the recommended Phase 2 dose of quavonlimab when used in combination with KEYTRUDA.

Quavonlimab25 mg Q6W + KEYTRUDAn=40

Quavonlimab25 mg Q3W + KEYTRUDAn=40

Quavonlimab75 mg Q6W + KEYTRUDAn=40

Quavonlimab75 mg Q3W + KEYTRUDAn=14

TotalN=134

ORR, %(95%, CI)

37.5(22.7-54.2)

40(24.9-56.7)

27.5(14.6-43.9)

35.7(12.8-64.9)

35.1(27.0-43.8)

PFS, median(95%, CI), mo

7.8(4.2-14.8)

6.0(2.0-8.3)

6.0(3.5-8.1)

3.4(1.8-NE)

6.1(4.2-7.3)

OS, median(95%, CI), mo

18.1(14.2-NE)

18.1(9.1-21.8)

17.1(9.0-NE)

13.7(3.5-NE)

16.5(14.2-21.8)

DOR, median(95%, CI), mo

NR(4.0 to 21.6+)

7.9(2.8 to 21.4+)

15.9(3.4 to 21.4+)

NR(8.8+ to 16.3+)

13.6(2.8 to 21.6+)

About Lung Cancer

Lung cancer, which forms in the tissues of the lungs, usually within cells lining the air passages, is the leading cause of cancer death worldwide. Each year, more people die of lung cancer than die of colon and breast cancers combined. The two main types of lung cancer are non-small cell and small cell. Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for about 85% of all cases. Small cell lung cancer (SCLC) accounts for about 10% to 15% of all lung cancers. Before 2014, the five-year survival rate for patients diagnosed in the U.S. with NSCLC and SCLC was estimated to be 5% and 6%, respectively.

About KEYTRUDA (pembrolizumab) Injection, 100 mg

KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the bodys immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Merck has the industrys largest immuno-oncology clinical research program. There are currently more than 1,200 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

About Quavonlimab (MK-1308)

Original post:
Merck Presents Three-Year Survival Data for KEYTRUDA (pembrolizumab) in Combination With Chemotherapy and Updated Phase 1/2 Data for Investigational...

The recent report titled Global Cryonics Technology Market Size, Status and Forecast 2020-2026 offered by Researchmoz.us, comprises of a comprehensive investigation into the geographical landscape, industry size along with the revenue estimation of the business. Additionally, the report also highlights the challenges impeding market growth and expansion strategies employed by leading companies in the Cryonics Technology market.

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Cryonics Technology Market Key Trends, Drivers, Challenges and Standardization To 2020-2026 - PRnews Leader

My very good friend Joanne recently revealed that she is starting radiation treatment for a very recent diagnosis of breast cancer. She found her lump and immediately contacted her physician. From then to now has been a whirlwind of activity. The area of concern started with an itch, but it really concerned her. Maybe it was imagination, she thought. She persisted, even when the mammogram wasnt seeing it. In this case her lump was positional undetectable when standing, but detectable when she leaned forward. It was tiny about half a centimeter (2.54 centimeters - 1 inch).

Joanne marked her area with a sharpie so radiographers would know. Her tumor is hormone (estrogen) driven. Ironically enough, Joanne always monitored her diet and instinctively avoided foods that promote hormones.

She eats much more healthy than I do. And she has no known family history. Her first treatment was Monday right before Breast Cancer Awareness Month October. The statistics are shocking 1 out of 8 women will suffer breast cancer. I wrote several columns on prevention in the past, and my information is meant to educate my readers. But I know it can strike anyone even those who eat a great diet and have a healthy lifestyle.

For those who are interested, there are foods and lifestyle practices that actually promote cancer, and then there are foods and lifestyle practices that can help prevent it. Lets review food and lifestyle practices that can PROMOTE cancer: High fat foods, nitrites (found in cured meat), eating the burnt part of charcoal grilled foods (acrolein), belly fat (look in a mirror), high levels of caffeine, cigarette smoking and second-hand smoke, heating foods in Styrofoam and plastic wraps, supplements containing boron and excessive use of soy, and even eating the same foods over and over. There is evidence that soy, mushrooms, broccoli and cauliflower, citrus fruits, flax seeds and fiber increase hormone production.

Then there are those that can PREVENT cancer: Eating more plant-based proteins (beans, legumes), drinking more water, a wide variety of fruits and vegetables especially those with deep colors (beets, winter squash, carrots), including fish at least weekly, eating low fat foods, eating more whole foods (a baked potato instead of French fries), using whole grains (rye or pumpernickel instead of plain white bread), eating a wide variety of foods (limits overexposure), staying physically active and achieving and maintaining a healthy weight range.

Joanne stresses the importance of self-detection. That, my dear readers, is just one more thing that we need to do on a regular basis. But it is so important. I have a monthly note on my Calendar in my iPhone to remind me to self-examine on the first of the month. Get familiar with what is normal and then pay attention to any changes. Johns Hopkins Medical Center states, Forty percent of diagnosed breast cancer are detected by women who feel a lump. Its also important to do a monthly visual inspection, too. You can Google how to perform the self-exam, which is recommended to do while in the shower.

As far as diet changes Plan at least one plant based dinner weekly beans and greenspasta and tomato sauce?? Thats easier on your pocketbook, too. Use baby carrots, apples, grapes, cut-up green peppers as snacks instead of chips and dip. Substitute flavored herbal teas for coffee and soda. Carry a water bottle around to have ready access to a healthier no calorie beverage. Use whole foods more in your meal preparation. It only takes 4 minutes to nuke a whole potato. Lets make surviving the easier option. Continue with PINK POWER!! And Im praying for my friend.

Jeannie Wolcott, RD, CDN, is a retired registered dietitian, licensed Zumba (R) instructor for adults and kids, and a coordinator of Old Forestport Days.

Read more here:
Eating healthier can reduce the risk of cancer - Rome Sentinel

FeaturesKieran Khan6 Hrs AgoLicensed naturopathic physician Dr Anna Maria Pouchet says people don't realise how seemingly little things impact them and make them susceptible to cancer. Photo courtesy Dr Anna Maria Pouchet

The key approach to dealing with cancer will always be with prevention," explained Dr Anna-Maria Pouchet, a licensed naturopathic physician with the Hope and Wellness Clinic, "and it starts with the things that many women and men overlook in their everyday life. They dont realise how seemingly little things impact them and make them susceptible to cancer.

Turmeric is a natural herb that can be used in the fight against cancer. Image taken from cdn-prod.medicalnewstoday.com

We need to be more aware how our cell phones, the lotions containing parabens, nail polishes, birth control tablets, laundry detergent, fabric softeners, bleach, and even the plastic bottles we drink from every day are impacting on our life as much as the antibiotics and pesticides in our foods are too.

The cancer-environment connection

Pouchet's view of the world we live in is echoed by dozens of documentaries and hundreds of research papers. Human beings are destroying the planet in a way that it is also in turn destroying us.

We are aware of the oestrogen hormone, but what people fail to recognise is that the amount of hormones produced in our bodies is so minimal but we absorb additives to our beauty products and our food, (and) in particular oral contraceptives, that contain milligrams of synthetic hormones milligrams when our bodies dont even need these amounts, she pointed out.

The result is that our kidneys and liver are overburdened by the detoxification of all (these) toxic chemicals, including excess hormones, and eventually we become nutrient-depleted by the process of eliminating and begin to store many of these in our fatty tissue which for women often means in the breasts and other areas like the hips, butt and thighs.

"Toxins also cause damage to our DNA and as a result our cells are not able to regulate and eventually mutate and become malignant, she elaborated.

Pouchet focuses on helping the body to function in the right way with proper diet, nutrition, detoxification, and supplementation, as needed.

Our hormonal balances are dependent on having proper functioning of our liver, kidney and a good gut flora so that we process and eliminate toxins. To achieve that you want to ensure you have sufficient intake of fibre and basic nutrients such as zinc, B vitamins, magnesium, etc.

"I highly recommend flaxseed or chia seeds daily along with lots of water. When it comes to water you also want to filter your water as best as you can. Flaxseed contains Omega-3 fatty acids and is especially important, in that it binds to excess oestrogen in the GI tract and gets it out the body.

Oral contraceptives contain synthetic hormones. Image taken from flushinghospital.org

According to LiveStrong.com, lignan by-products are known to bind to the oestrogen receptors found in body tissues, shifting oestrogen production to weaker forms which do not enhance cancer cell growth. The lignans found in flax may also inhibit aromatase, an enzyme which produces oestrogen.

Pouchet also advises everyone to invest in their health with good quality daily vitamin and mineral supplements to avoid nutritional deficiencies, even if they think they eat well.

And what if you are diagnosed?

Depending on the stage of the cancer and the size of the tumour as well as the course of treatment chosen, there is a lot that you can do for yourself to help you beat cancer.

Pouchet says, Research shows that there are herbs that work with the chemotherapy synergistically, which help to protect your healthy cells while they go through the process. There are also natural herbs that fight cancer and should be used for prevention of tumours, like turmeric, green tea, aloes, ginger, for example.

People living with cancer also struggle to get the daily intake of nutrients needed to fight the disease. Pouchet suggested supplementing as needed, and avoiding sugar, refined carbohydrates and, as far as possible, to turn to steamed cruciferous vegetables and probiotics to fuel and feed the gut lining, which is damaged by chemotherapy.

The emotional connection

In addition to diet and exercise, there is one key area Ikeen to learn Pouchet insights on cancer and its emotional roots. There are areas of research that link the onset of cancer to emotional disturbances or upheavals in peoples lives.

Pouchet agrees.

There is absolutely a connection. Many natural oncologists point out that cancer starts with the collapse of the nervous system or the sympathetic and parasympathetic systems in our bodies. The autonomic nervous system regulates many bodily functions, and they have links to every organ, especially our digestion.

According to licensed naturopathic physician Dr Anna Maria Pouchet, flaxseed contains Omega-3 fatty acids and binds to excess oestrogen in the GI tract and gets it out the body. Image taken from cdn-prod.medicalnewstoday.com

"From my own work I have seen patients that point out that there was a divorce or some form of recent conflict in their lives prior to their diagnosis. Negative emotions are involved in the breaking down of how the body protects itself and can create openings for the emergence of cancer, she said.

Given the emotional disturbances brought on by the covid19 pandemic, keeping positive eating habits and healthy exercise regimens should be an area of focus for everyone.

Though covid19 dominates our headlines, lifestyle diseases are still the leading causes of preventable death in TT.

Dr Anna Maria Pouchet is a licensed as a naturopathic physician by the State of Washington who practises in Trinidad. Education and medical training was at Bastyr University, which is one of four accredited naturopathic programmes in the US and internationally recognised as a pioneer in the natural sciences. Always consult a medical doctor or nutritionist before starting major diet changes.

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Cancer, naturopathy and emotional roots - TT Newsday

While antibody-drug conjugates (ADCs), such as fam-trastuzumab deruxtecan-nxki (Enhertu), may have shown efficacy in patients with HER2-low breast cancer in initial studies, according to Sara M.Tolaney, MD, MPH, investigators still need better methods for identifying this disease subtype to guide treatment decisions.

What we're learning is that we really need to improve our ability to detect very low levels of HER2 expression, said Tolaney. Testing will need to change so that we can potentially address all patients who are able to benefit from these therapies.

In an interview with OncLive, Tolaney, associate director of the Susan F. Smith Center for Womens Cancers; director of Clinical Trials, Breast Oncology;andsenior physician at Dana-Farber Cancer Institute, as well as anassistant professor of medicine at Harvard Medical School, discussed the challenges in treating patients with heterogenous HER2 expression and what treatments could potentially improve outcomes for this subgroup.

Tolaney: Some challenges that we face surround the patients who have heterogeneous expression for HER2. For example, it's not that the entire tumor is strongly HER2-positive. We've learned from a couple trials, 1 of them being the KRISTINE trial, and another that is exploring heterogeneity in the preoperative setting, that having heterogeneous HER2 expression can impact the efficacy of ado-trastuzumab emtansine [T-DM1; Kadcyla].

The other challenge is: What about patients who, for example, lose HER2 expression after preoperative therapy? Many of us are uncertain with what to do with those patients who have residual disease, but at the time of surgery are no longer HER2-positive. We did see some data from the KATHERINE study, which showed that even those patients who had HER2-negative disease at the time of surgery, despite being HER2-positive prior to preoperative therapy, still benefited from adjuvant T-DM1, which was quite interesting. There are all of these complexities that come up when caring for patients, but again, we're quite fortunate to have so many nice treatment options in this setting.

HER2-low is defined as tumors with a little bit of HER2 expression but aren't quite HER2-positive. What that means is that if a patient, for example, has a tumor that is 1+ by immunohistochemistry [IHC], we would consider them HER2-lowpositive. If they're HER2 2+ by IHC and is not amplified via fluorescence in situ hybridization [FISH], we would also consider them HER2-lowpositive.

We've seen from various datasets that about 55% of all breast cancers are actually HER2-low, which is a significant proportion of our patients with breast cancer. We do know that the prevalence is different by hormone receptor [HR] expression. [About 60% of] HR-positive tumors are more commonly HER2-lowpositive, as opposed to triple-negative breast cancers where only about one-third of those cases will end up being HER2-lowpositive. The prevalence is different based on breast cancer subtype.

We've seen some initial attempts looking to see if trastuzumab [Herceptin] would have any benefit in patients with a little bit of HER2 expression. We have seen data from a randomized phase 3 trial where, in fact, there was no benefit from trastuzumab added to chemotherapy in the early breast cancer setting for patients with HER2-lowpositive [disease].

What we have seen now is that some of the new ADCs do have activity in these tumors. For example, trastuzumab deruxtecan was explored in patients who were HER2-lowpositive. We saw that the objective response rates [ORRs] were almost 40% in this population; this response was similar for patients who had HER2 1+ disease compared with HER2 2+ disease; these data suggest very impressive efficacy in this subgroup.

Many of us have been a little bit perplexed about why some drugs work for HER2-lowpositive disease and others don't. For example, [when using] trastuzumab deruxtecan, we're seeing an almost 40% ORR, but we did not see significant responses with T-DM1 in subsets of HER2-lowpositive patients. Why is this? We truthfully don't have the answer, but it may be that you're delivering more chemotherapy with trastuzumab deruxtecan than you are with T-DM1. Perhaps that's why you need just a bit of HER2 expression to get that binding of the ADC and get the drug into the cancer cell.

We have also seen this with other novel ADCs, such as [vic-]trastuzumab duocarmazine [SYD985], where we've also seen ORRs between 25% and 30% in HER2-lowpositive disease. Again, this is very promising and there are lots of other drugs in development that are being studied in this setting, such as new bispecific antibodies. Were going to see many more [treatments] come in this space. There is even a registration trial ongoing with trastuzumab deruxtecan compared with standard chemotherapy for HER2-lowpositive patients.

Right now, testing for these breast cancers is really quite rudimentary and is via IHC. If a patient is HER2 1+, they would be HER2low-positive and if they are HER2 2+ but not FISH-amplified, they would be HER2low-positive. We need to see if there are better tests that can be done to detect very low levels of HER2 expression, because there may be some patients who have tumors [that dont show any positivity but have] low levels of expression that just don't quite meet criteria to be HER2 1+ that may benefit from some of these novel ADCs.

Right now, I'm very excited about the ongoing registration study for trastuzumab deruxtecan compared with physicians choice for patients who have received 1 or 2 prior chemotherapies for metastatic HER2-lowpositive breast cancer. Seeing ORRs that are near 40%, at least in the early single-arm studies, makes us quite excited about the potential to get this level of activity. This would be a nice opportunity for patients to get more personalized treatment that could improve their outcomes.

We've seen a lot of very interesting data come out about approaches to take for patients who have early-stage, HER2-positive disease. Prior to 2 or 3 years ago, we were predominantly treating patients in the adjuvant setting with HER2-directed therapy, but we have since learned that it's quite critical to give the majority of our patients preoperative therapy because we can adapt postoperative treatment to improve outcomes.

Data have evolved over the last year, and we've learned that giving adjuvant ado-trastuzumab emtansine [T-DM1; Kadcyla] can improve outcomes for patients with residual disease after neoadjuvant HER2-directed therapy.

Also, we can augment outcomes for patients by adding an additional biologic therapy, such as pertuzumab [Perjeta], to our patients who are getting chemotherapy and trastuzumab [Herceptin]. We certainly have a lot of tools added to our toolbox, but we've been trying to refine that even further. That's what the focus of a lot of the more recent developments have been on. Now that we have all of these very effective biologic therapies, can we potentially de-escalate therapy for patients who may be at lower risk? Can we potentially escalate therapy for those who may be of a higher clinical risk?

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Tolaney Touches on HER2+ -Low Breast Cancer Testing, Possibilities, and Challenges - OncLive

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Theres so much going on in the markets, that its hard to know where to start and what to look for. On the red side of the ledger, its clear that the headwinds are gathering. House Democrats are still rejecting the $1.8 trillion coronavirus aid and stimulus package put forth by the White House, saying that President Trumps proposal does not go far enough. The House Dems are pushing their own $2.2 trillion stimulus. At the same time, both Eli Lilly and Johnson & Johnson have paused their coronavirus vaccine programs, after the latter company reported an adverse event in early trials. This has more than just investors worried, as most hopes for a return to normal hang on development of a working vaccine for the novel virus.And earnings season is kicking off. Over the next several weeks, well see Q3 results from every publicly traded company, and investors will watch those results eagerly. The consensus is, that earnings will be down year-over-year somewhere between 20% and 30%. With this in mind, weve used theTipRanks databaseto pull up three dividend stocks yielding 6% or more. Thats not all they offer, however. Each of these stocks has a Strong Buy rating, and considerable upside potential.Philip Morris (PM)First on the list is tobacco company Philip Morris. The sin stocks, makers of tobacco and alcohol products, have long been known for their good dividends. PM has taken a different tack in recent year, with a turn toward smokeless tobacco products, marketed as cleaner and less dangerous for users health.One sign of this is the companys partnership with Altria to launch and market iQOS, a heated smokeless tobacco product that will allow users to get nicotine without the pollutants from tobacco smoke. PM has plowed over $6 billion into the product. Given the regulatory challenges and PR surrounding vaping products, PM believes that smokeless heated tobacco will prove to be the stronger alternative, with greater potential for growth.No matter what, for the moment PMs core product remains Marlboro cigarettes. The iconic brand remains a best seller, despite the long-term trend of public opinion turning against cigarettes.As for the dividend, PM has been, and remains, a true champ. The company has raised its dividend payment every year since 2008, and has reliably paid out ever quarter. Even corona couldnt derail that; PM kept up its $1.17 quarterly payment through 2020, and its most recent dividend, paid out earlier this month, saw an increase to $1.20 per common share. This annualizes to $4.80, and gives a yield of 6%.Covering PM for Piper Sandler, analyst Michael Lavery likes the move to smokeless products, writing, We remain bullish on PM's strong long-term outlook, and we believe recent iQOS momentum throughout the COVID-19 pandemic has been impressive. iQOS has had strong user growth and improving profitability, and store re-openings could further help drive adoption by new users.Lavery rates PM shares an Overweight (i.e. Buy), and his $98 price target implies a one-year upside of 24%. (To watch Laverys track record, click here)Overall, the Strong Buy consensus rating on PM is based on 9 reviews, breaking 8 to 1 in Buy versus Hold. The shares are priced at $79.10 and their $93.56 average price target suggests an 18% upside potential. (See PM stock analysis on TipRanks)Bank of N.T. Butterfield & Son (NTB)Butterfield is a small-cap banking firm based in Bermuda and providing a full range of services to customers on the island and on the Caymans, the Bahamas, and the Channel Islands, as well as Singapore, Switzerland, and the UK. Butterfields services include personal and business loans, savings accounts and credit cards, mortgages, insurance, and wealth management.Butterfield saw revenues and earnings slide in the first half of this year, in line with the general pattern of banking services globally the worldwide COVID-19 pandemic put a damper on business, and bankers felt the hit. Earnings in the last quarter of 2019 were 87 cents per share, and by 2Q20 were down to 67 cents. While a significant drop, that was still 21% better than the expectations. At the top line, revenues are down to $121 million. NTB reports Q3 earnings later this month, and the forecast is for 63 cents EPS. Along with beating earnings forecasts, Butterfield has been paying out a strong dividend this year. By the second quarter, the dividend payment was up to 44 cents per common share, making the yield a robust 7%. When the current low interest rate regime is considered the US Fed has set rates near zero, and Treasury bonds are yielding below 1% NTBs payment looks even better.Raymond James Donald Worthington, 4-star analyst with Raymond James, writes of Butterfield, robust capital levels [provide] more than sufficient loss absorption capacity in our view for whatever credit issues may arise. Its fee income stability has proven valuable given the impacts of declining rates on NII, where the bank has actively managed expenses to help support earnings. We continue to believe its dividend is safe for now given its low-risk loan portfolio, robust capital levels, and our forecast for a sub-100% dividend payout even under our stressed outlook.These comments support the analysts Outperform (i.e. Buy) rating, and his $29 price target suggests a 15% upside for the coming year. (To watch Worthingtons track record, click here)Overall, NTB has 4 recent reviews, which include 3 Buys and a single Hold, making the analyst consensus rating a Strong Buy. This stock has a $29 average price target, matching Worthingtons. (See NTB stock analysis on TipRanks)Enviva (EVA)Last on our list is an energy company, Enviva. This company holds an interesting niche in an essential sector, producing green energy. Specifically, Enviva is a manufacturer of processed biomass fuel, a wood pellet derivative sold to power generation plants. The fuel is cleaner burning than coal an important point in todays political climate and is made from recycled waste (woodchips and sawdust) from the lumber industry. The companys production facilities are located in the American Southeast, while its main customers are in the UK and mainland Europe.The economic shutdowns imposed during the corona pandemic reduced demand for power, and Envivas revenues fell in 1H20, mainly due to that reduced demand. Earnings remained positive, however, and the EPS outlook for Q3 predicts a surge back to 45 cents in line with the strong earnings seen in the second half of 2019.Enviva has shown a consistent commitment to paying out its dividend, and in last quarter the August payment the company raised the payment from 68 cents per common share to 77 cents. This brought the annualized value of the dividend to $3.08 per share, and makes the yield 7.3%. Even better, Enviva has been paying out regular dividends for the past 5 years.Covering this stock for Raymond James is analyst Pavel Molchanov, who rates EVA as Outperform (i.e. Buy) and sets a $44 price target. Recent share appreciation has brought the stock close to that target.Backing his stance, Molchanov writes, Enviva benefits from an increasingly broad customer base, and there is high-visibility growth via dropdowns. In the context of the power sector's massive coal retirements including (as of September 2020) 34 countries and 33 subnational jurisdictions with mandatory coal phase-outs (To watch Molchanovs track record, click here.)Envivas Strong Buy consensus rating is based on 4 Buys and 1 Hold. Its share price, which has gained in recent sessions, is $42.60, and as mentioned, it has closed in on the $44.80 average price target. (See EVA stock analysis at TipRanks)To find good ideas for dividend stocks trading at attractive valuations, visit TipRanks Best Stocks to Buy, a newly launched tool that unites all of TipRanks equity insights.Disclaimer: The opinions expressed in this article are solely those of the featured analysts. The content is intended to be used for informational purposes only. It is very important to do your own analysis before making any investment.

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New Comprehensive CBD Alternative from Life Extension, Introducing Endocannabinoid Support, without THC or Hemp - Yahoo Finance

DetailsCategory: More NewsPublished on Friday, 16 October 2020 13:41Hits: 187

SAN DIEGO, CA, USA and FREISING, Germany I October 15, 2020 I Life Science Newswire Antlia Bioscience, Inc., a privately owned biopharmaceutical company located in San Diego, California, and XL-protein GmbH, a privately owned biopharmaceutical company located in Germany, are pleased to announce a strategic slliance using XL-protein's proprietary PASylation technology for plasma half-life extension to develop a novel, long-acting, peptide therapeutic treatment for chronic heart failure. Brian Johnson, Antlia Biosciences CEO commented, "chronic heart failure is a significantly unaddressed medical condition and a major public health concern. XL-protein's PASylation technology will allow us to safely and effectively translate our peptide into a meaningful therapeutic option for patients with chronic heart failure. "PASylation is an excellent biological solution for plasma-half extension of therapeutic peptides, and we believe that PASylation offers a simpler manufacturing process and superior pharmacological properties," commented Claus Schalper, CEO of XL-protein. "We are excited to work with Antlia Bioscience to further exploit the potential of our technology and to develop new therapeutic options for the treatment of chronic heart failure." Financial terms of the agreement have not been disclosed.

About PASylation Technology

'PASylation' involves the genetic fusion or chemical conjugation of a therapeutic protein or pharmaceutically active compound with a conformationally disordered polypeptide of defined sequence comprising the small natural amino acids Pro, Ala, and/or Ser. Due to the biophysical size effect, the typically rapid clearance via renal filtration of the original drug can be retarded by a factor 10-100, depending on the length of the PAS chain. PAS sequences are highly soluble while lacking charges, they are biochemically inert, non-toxic and non-immunogenic, they offer efficient recombinant protein production in a variety of biotechnological host organisms, and they show high stability in blood plasma but are biodegradable by intracellular proteases.

About XL-protein GmbH

XL-protein is a German biotech company commercializing its ground-breaking PASylation technology, which enables the design of biopharmaceuticals with extended plasma half-life and enhanced action. Based on a strong proprietary technology position, XL-protein focuses at the preclinical as well as clinical development of PASylated proteins in diverse disease areas. XL-protein is engaged in a growing number of partnerships with international pharmaceutical and biotech companies at various levels.

For more information, please visit: http://www.xl-protein.com

About Antlia Bioscience, Inc.

Antlia Bioscience is a San Diego-based biotech developing groundbreaking peptide-based therapies to treat cardiovascular and metabolic diseases. Using PASylation and other state-of-the-art techniques, we turn promising peptides into groundbreaking therapies. We are driven to make a profound difference in the treatment of cardiovascular and metabolic diseases and believe that our efforts will result in a paradigm shift in how cardiovascular and metabolic diseases will be treated in the future.

For more information, please visit: antliabio.com

SOURCE: Antlia Bioscience

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XL-protein and Antlia Bioscience Announce Collaboration to Develop Long-acting Peptide Therapy of Chronic Heart Failure using PASylation Technology |...

If Im telling the truth, Ive been outside my apartment maybe three times this weekand thats a generous estimate.

Since I started strictly working from home, Ive accepted the fact that the inside of my not-so-spacious New York apartment is where youll find me for the foreseeable futurewhich also means my former Florida gal days of soaking up ample vitamin D are far, far behind me.

But it turns out Im not the only one lacking in vitamin D, and its not just a WFH-specific problem either. According to Michael A. Smith, MD, director of education at Life Extension, many people in the U.S. have insufficient vitamin D levels (more on the difference between deficient and insufficient below), and they have for some time.

These insufficiencies are nothing new to 2020, Dr. Smith says. Its more the product of an issue that were starting to recognize now.

In fact, a recent study showed that up to 30 percent of aging adults are actually vitamin D deficient, and sunlight alone is not likely enough to increase their vitamin blood levels to any significant degree, says Dr. Smith.

These insufficiencies are nothing new to 2020.

Lacking vitamin D isnt the only way I recognized spending more time at home might be affecting my health. Given the heightened stress of 2020 in general, I havent been totally feeling like myself. So, I decided to chat with Dr. Smith about what I can do about it.

Stress can zap your body of all vitamins and minerals, Dr. Smith says. Stress is an activator of your system. It turns on your drive for fight or flight. And, since theres a vitamin D receptor in every type of cell in the human body, he explains, its connected to many of those systems.

According to Dr. Smith, the easiest first step to get my well-being on track is supplementing, so after chatting with him, I picked up Life Extension Vitamin D3 to try for myself. Supplementation can bring you into optimal range quicker, and sustain you there over time, Dr. Smith adds. Sign. Me. Up.

Although somestudies suggest as much as 42 percent of the U.S. population is deficient in vitamin D, Dr. Smith says examining vitamin Dinsufficiencyis more useful for correcting the problem.

There are two words: deficiency and insufficiency, which are the two official medical words for low levels,' Dr. Smith says. Most people dont meet the medical definition of deficiency, instead, there is a widespread insufficiencyso were really just talking about people who are suboptimal. And suboptimal isnt your goal here.

My biggest question was: How can you tell when youre actually insufficient? According to Dr. Smith, the signs are different for different people, but they tend to show up during cold and flu season and can include cold symptoms, fatigue, and mood changes, among other things. People tend to be lower in mood in fall and winter months, but it might be even a little worse for someone who is insufficient, Dr. Smith says.

I didnt feel like I could pin-point my exact vitamin D insufficiency signals (my mood goes up and down all the time), but that doesnt mean there might not be consequences later on, according Dr. Smith. Its important to understand that vitamin D is such a key nutrient for so many body processes, he says. You need sufficient levels of it to support heart, immune, and bone health. Heres to taking measures now that my 50-year-old self will thank me for.

Now that I know the importance of vitamin D for both my immediate and long-term health, I recognized I needed to make a few changes. Off the bat, Dr. Smith suggested trying to reduce the stress in my life. Stress is a zapper of energy and micronutrients, he says. For people who deal with it, its not uncommon to truly be [vitamin D] insufficient because their body is just on all the time.

Some of the best ways to reduce stress, according to Dr. Smith, are going outside and exercisingtwo things that on their own also help to increase your vitamin D levels (and two things I could definitely do more of).

Another way to target stress is to use supplements to promote better relaxation. In addition to vitamin D (which can also help maintain healthy blood pressure), Dr. Smith suggested I take a multivitamin (for overall health), melatonin (to ensure Im getting high-quality zzzs), and Life Extension Enhanced Stress Relief, which helps to raise more relaxation hormones and battles that always-on feeling, Dr. Smith says.

Coming out of my chat with Dr. Smith, I have two main goals: Sticking to an easy-but-effective supplement routine (already on it), and spending at least 30 minutes a day outside. A walk around my city block might not be the same as a sunny stroll down the beach, but Im about to be well on my way to Florida-levels of vitamin D.

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Photo: Getty Images/Ivan Pantic

These statements have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure, or prevent any disease.

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Im Definitely Getting Less Vitamin D Since Ive Been Cooped Up IndoorsBut What Does That Actually Mean? - Well+Good

On-orbit service and logistics startup Astroscale has raised a $51 million Series E funding round, bringing its total raised to date to $191 million thus far. The Japan-based company has been focused on delivering new solutions for orbital end-of-life meaning ways to make orbital operations more sustainable by offering easy ways to safely de-orbit spacecraft after the end of their useful service life, clearing up some of the growing orbital debris problem thats emerging as more companies create satellites and constellations.

Astroscale has since expanded its mission to also include extending the life of geostationary satellites another key ingredient in making the orbital operating environment more sustainable as we look toward a projected exponential explosion in orbital activity. The startup announced earlier this year that it was acquiring the staff and IP of a company called Effective Space Solutions, which was in the process of developing a space drone that could launch to provide on-orbit servicing to large, existing geostationary satellite infrastructure, handling tasks like refueling and repairs.

ESS has formed the basis for Astroscale Israel, a new international office for the globe-spanning Astroscale that will be focused on geostationary life extension. Todays funding was led by aSTART, and will be used to help the company continue to establish its global offices and increase the team to more than 140 people.

Astroscales end-of-life orbital debris-removal technology is set to get its first demonstration mission sometime in the second half of this year, with a launch aboard a Russian Soyuz rocket. The system uses two spacecraft that find and latch on to target debris to be de-orbited.

Go here to read the rest:
Astroscale raises $51 million in Series E funding to fuel its orbital sustainability ambitions - TechCrunch

Even a casual observer of the contemporary global strategic environment will concur that nuclear weapons are very much back in the picture as several countries including the United States and China seek to modernize their arsenals and develop new capabilities. With many nuclear powers pushing their envelope and, in some cases, luck, and the future of arms control under stress, the current nuclear environment is defined by several challenges around proliferation and escalation risks.

To understand them better, The Diplomat spoke to Vipin Narang, associate professor of political science at the Massachusetts Institute of Technology (MIT) and member of MITs Security Studies Program. Narang, also a nonresident scholar in the Nuclear Policy Program at the Carnegie Endowment for International Peace, is author of Nuclear Strategy in the Modern Era (Princeton University Press, 2014).

In your opinion, what are the top three nuclear challenges the world faces today?

First, vertical proliferation, and specifically renewed great power nuclear competition and arms racing, threatens to upset decades of trends that enhanced strategic and crisis stability. Russian and Chinese modernization programs largely driven by Americas large conventional and nuclear counterforce capability and the unfulfilled fantasy of American national missile defenses aim to survive an American strike and penetrate defenses. That has led to a variety of programs, including hypersonic glide vehicles, nuclear-powered cruise missiles, and the oldie but goodie building up mobile capabilities. The US threatens to respond in kind with the withdrawal from the INF Treaty and the prospect that New START is not renewed with Russia. All of these developments threaten to disturb strategic stability.

Second, horizontal proliferation. However, we face not just the looming risk of adversarial proliferation states such as Iran but also of allied proliferation, in states such as South Korea, Germany and even Japan, due to concerns surfaced during the Trump administration that the United States may not indefinitely provide credible extended deterrence. In addition, a third class of states, frenemies like Saudi Arabia, who have promised to acquire nuclear weapons if their primary adversary (Iran in this case) does are also flirting with the idea and capabilities for at least a nuclear hedge. We may be on the cusp, in the next decade or two, of a cascade of new nuclear weapons powers.

Third, 75 years after the last wartime use of nuclear weapons, todays nuclear weapon states seem less chastened by the prospect of nuclear use and escalation and are increasingly pushing the line against other nuclear weapons powers, attempting to break free of the constraining effects of being deterred. The last year has seen some disturbing firsts: India bombing the undisputed territory of another nuclear weapons power at Balakot for the first time in history, and Turkey an American ally which hosts US nuclear weapons at Incirlik firing at American troops. The problem with the threat that leaves something to chance, is that it leaves something to chance. And as nuclear states push the line against other nuclear states, even if they do not want a war war may find them. That is, nuclear powers are increasingly running the risk that they may stumble into a war, and that would put us in uncharted territory.

You have warned against Trumps North Korea strategy (if one can call it that) and have been consistently pessimistic about the prospect of denuclearization there. As a new administration takes over in January, what advice would you give the new president about Kim Jong Un and his nukes?

I have long argued that Kim Jong Un will not voluntarily surrender his nuclear weapons program and taking it away by force as some like John Bolton [the former US national security advisor] continued to advocate even after North Korea tested an ICBM and purported thermonuclear weapon is exceptionally dicey. But that does not mean that we cannot try to slow down the growth of the program, seek caps on certain capabilities, and keep the rhetorical fiction of denuclearization of the Korean Peninsula as an end goal that we accept is unlikely to ever be achieved.

In fact, it appears that this deal Yongbyon in exchange for some sanctions relief was on the table at Hanoi. If verified and completed, that would have shut off North Koreas only known source of plutonium and tritium production, and a nontrivial proportion of its uranium enrichment. This could have slowed the growth of the nuclear program and shaped the future composition of the force by starving it of further plutonium and potentially tritium (for thermonuclear weapons). But Trump walked away, claiming it was too small a deal. Instead, we got no deal and Kim Jong Un continues to expand and improve his nuclear and missile force.

I suspect we will look back at Hanoi with regret, though it is possible a similar deal may resurface. If it does, I believe we should take it. Slow, cap, rollback, and eliminate (even if we never get there) for corresponding measures, in tandem, is a sensible formula to manage a nuclear North Korea.

We recently saw North Korea flash a new missile capability during its annual parade. Any thoughts on what the missile may portend in terms of where Kim sees his nuclear capabilities going in the future?

For a year, Kim Jong Un had been promising a new strategic system, and on October 10 we discovered that it was a new heavy transportable liquid fuel ICBM, based on its Hwasong-15 ICBM. This new missile is one of the worlds largest mobile liquid fuel missiles and the key feature is the large payload it can seemingly deliver, such as potentially penetration aids or multiple warheads, to defeat American national missile defenses which may not work well today, but which adversaries such as Russia, China and North Korea fear may work tomorrow.

This new missile was not a surprise, and largely represents a continuing evolution of North Koreas growing missile and nuclear capabilities. It is designed to solve one of two North Korean strategic problems: penetrating American missile defenses. There were questions about whether North Korea could develop warheads compact enough for MIRVs (multiple warheads on a single missile), but the size of this missile obviates some of that problem your cars can be bigger if you build a gigantic garage. However, the missile is so big and slow, and takes so long to potentially fuel, that it may exacerbate the other problem survivability but I think we should fully expect that North Korea is also working on capabilities to address that concern, such as a mobile solid fuel ICBM that is easier to hide and prompter to launch. In fact, we may have seen tantalizing hints of that capability as well in the parade, and that would represent a bigger leap for the program. In any event, these developments and improvements which are still away from being operational are precisely what normal nuclear powers do, and further suggests that Kim Jong Un has no intention of surrendering his nuclear weapons program.

We have heard a lot from the Trump administration of late about Chinas nuclear ambitions. How do you assess the trajectory of Chinas nuclear weapons and delivery platforms, as well as its doctrine?

Lets start with the facts: China has maybe 200 nuclear weapons that can range the continental United States, very few of which are deployed during peacetime. The United States, by contrast, has well over a 1,000, depending on your accounting, that are ready within minutes to range mainland China. This does not even account for the warheads in the stockpile that can be quickly uploaded to American ICBMs and SLBMs which are not fully MIRVd under New START. So even a doubling of Chinas strategic nuclear force still leaves it multiples lower than the United States and Russia.

My main reaction to Chinese nuclear modernization is: What took it so long to start? For decades, it lived with a posture of plausible retaliation with maybe two dozen ICBMs that could range the continental United States. With growing conventional and nuclear counterforce capabilities, and the unrelenting pursuit of national missile defenses which can in combination threaten to neutralize Chinas second strike capability, by eliminating a large portion of the ICBMs and relying on missile defenses to intercept the residuals the question is why China only started investing in mobility and numbers and penetration aids/hypersonics in the last decade or so. To me, all of these developments are Chinas delayed effort to guarantee assured retaliation. Chinas massive buildup in conventional short-range ballistic missile capabilities obviates the need for it to rely on nuclear weapons in a theater scenario, though scholars such as Caitlin Talmadge have pointed out that we cannot sleep on the risks of inadvertent Chinese nuclear escalation. But, I see continuity in overall strategy, and a delayed effort to develop the capabilities and deployment patterns mobility, penetration, SSBNs to implement that strategy with greater assurance.

What do you make of the hype around hypersonics? What about claims around artificial intelligence and nuclear command and control?

The pursuit of hypersonics is again driven by the unfulfilled fantasy of working national missile defenses. Presently, long range missile reentry vehicles, and certainly maneuverable reentry vehicles, which are decades-old technology, are perfectly sufficient to penetrate American missile defenses. And all of these reenter the atmosphere at hypersonic speeds. The advent of the new generation of hypersonics are actually slower than long range reentry vehicles. But some are air breathing and can maneuver and porpoise at very high altitudes in the event missile defenses ever work. So, at least in the medium term, Im a skeptic that these capabilities fundamentally alter the strategic balance. Russia and China do not face a penetration problem at the moment, so hypersonic glide vehicles only have marginal value at the moment.

Similarly, there is a lot of hype over AI and command and control, but a lot remains to be seen whether it affects a states ability to maintain command and control or disrupt it. AI may help solve some detection and ISR problems, but the general cat-and-mouse game of emerging technologies and counter-responses is a decades-old phenomenon.

What do you think about future arms control measures for emerging technologies?

Like all arms control measures, the empirical record suggests they will emerge and be adhered to when both states view them as being in their interests, which is unsatisfying and tautological but also the reality. States with an asymmetric advantage in a particular technology will oppose limits on it, while those that fear it will seek those limits. The zone of overlap generally emerges when both or all sides perceive a benefit in capping or limiting that capability either amongst themselves or collusively to prevent the diffusion of technology to other states. I am not an arms control skeptic so much as an arms control realist.

How do you assess the prospects of the New START treaty being extended, if Trump is reelected next month?

Ultimately, I do think New START will be extended no matter who wins the election. I think the Trump administration is attempting to play chicken with New START to try to pressure Russia into limiting, for example, its tactical nuclear weapons capability. But ultimately, a New START extension is in Americas interest: arms controllers love it because it is arms control and counter-forcers should love it because it provides a cap and accounting on the systems they have to eliminate. The only constituency that opposes New START are arms racers who believe that an arms race with Russia is good and easy to win. But in the current economic climate, there may be little appetite for a renewed arms race, or even persistent uploading of warheads from the stockpile. And Russia has an interest in New START for similar economic and management reasons. It is possible that a second Trump administration would only extend New START for one year and attempt to negotiate something stronger or multilateral in that year he may in fact try to do this before the election itself. I do not think there is any chance of China joining a multilateral equivalent of New START it would either be an invitation for it to build to parity with the US and Russia, or force it to agree to inequitable limits, which it will never do. But I do think we will see an extension of the bilateral New START at the end of the day. But whether it is for one or five years remains to be seen.

Would a Biden administration, come January, roll back some of Trumps nuke modernization plans?

The Democrats, in general, seek a safe, secure, and effective nuclear deterrent for the United States and Americas allies at an affordable cost. Although there was a loose bipartisan consensus for the modernization program, there are some components that may be revisited. For example, the ICBM replacement, the ground based strategic deterrent, could be forsook for another life extension of Minuteman III, which may save some cost. I do think certain capabilities, such as the low yield SLBM and the nuclear sea launch cruise missile, could be rolled back. But those are not so much part of the modernization program as particular capabilities that the Trump administration believed filled a deterrent gap, which I suspect many in a Biden administration remain unconvinced ever existed

To your mind, have India and Pakistan learnt the wrong lessons about escalation after Indias February 2019 Balakot air strikes and Pakistans retaliatory action?

I hesitate to judge what lessons either side may have privately taken away from Balakot, but at least publicly both sides seem to underestimate the role that pure luck played in keeping the crisis from further escalating. I think, for example, that if Indian fighter pilot Abhinandan Varthaman had been killed when his MiG-21 was shot down, or if he had died in Pakistani custody, or if there was a delay in his return and Prime Minister Narendra Modi carried out an alleged surface-to-surface missile strike, the crisis could have quickly escalated as domestic political pressure to hit back boiled over. Even in this case, where neither state wanted a broader war, both sides do seem to underestimate the risk that they came very close to stumbling into one. In general, Indias frustration with Pakistans continued use of terror against the Indian homeland is leading it to see how far it can push the line against another nuclear weapons power. That frustration is understandable, but it does not mean that pushing the line is risk-free.

I am disappointed you did not ask me about my hobby horse: the sanctity of Indias No First Use (NFU) declaration! At this point, no one believes the absoluteness of Indias NFU declaration though it sort of remains official doctrine including, most importantly, Indias government itself.

Read the article in The Diplomat.

See more here:
Vipin Narang on the global nuclear landscape: hype and reality | News - MIT News

Earlier this month, FoodBytes! Pitch announced that 45 companies will participate in the start-up discovery platform, which provides corporate leaders and investors exposure to a group of innovative start-ups, with opportunities for deeper interaction and networking throughout the year.

The FoodBytes! Pitch competition, which has been running for five years, will be staged virtually in 2020 due to COVID restrictions.

Participants were chosen from nearly 340 submissions from across the globe and six European applicants made the cut.

A predominant focus among start-ups based in Europe is digitising the supply chain, from farm to fork, Rabobank noted.

Greven said that this is reflective of the challenges faced by food corporates, who have had to evaluate their distribution strategies in recent years.

According to a report from Rabobanks supply chain experts, many US and European food companies have been ramping up discussions on distribution strategies in the past few years. The main reason for this is a rise in logistics costs due to an increasing variety of distribution channels and stricter fulfilment requirements set by customers. In Europe specifically, as corporates look to drive cost efficiency, the outsourcing of food logistics is once again growing, the investment expert told us.

Start-ups are bringing innovative solutions to the table, as reflected in the latest FoodBytes! cohort.

Switzerlands Koa, for instance, focuses on providing digital tools to smallholder farmers in order to create a transparent cocoa product. Meanwhile, Norwegian Farmforce is working to create a mobile platform to secure sustainable sourcing for farmers. At the consumer end of the chain, UK start-up Good Club aims to provide consumers with a go-to online market for sustainable food products.

As well as addressing efficiency and cost, supply chain technologies are helping to strengthen the food system and build a more resilient and sustainable supply chain, Greven continued. All of these technologies address various and important areas across the supply chain from loss mitigation (shelf-life extension and food safety), food e-commerce (accessibility and transparency), and connected marketplaces that help close the gap between farmers and consumers.

The ability of agile start-up innovators to develop new and pioneering approaches to the table has driven investment in the space. Indeed, Greven noted:Half of capital invested into European food and ag start-ups in 2020 has been to midstream technologies focused on supply chain efficiency and digitisation."

This figure is higher than the level seen in the US, where that number is closer to 40%, she added.

Biotechnology and cellular solutions also offer the opportunity to re-think how we produce food and source materials.

New understandings of the role biosciences can play in the food industry can help address major challenges from agricultural production to food quality and health and nutrition.

Were seeing excitement from our community of experts and corporates surrounding the development of next gen food technologies, Greven observed.

Greven said that the rapid development of this sector means that applications from biotech companies to FoodBytes! are also increasing.

Our biotech applications globally are on the rise in 2019 and 2020, biotech companies comprised of 10% of applications received, double that of the two years preceding.

This years FoodBytes! saw a total of three start-ups two of whom are European focused on cell-based meat and fermented protein.

CellulaREvolution has developed cell-culturing meat technology utilising a cell coating to facilitate the continuous production of proteins, rather than in batches, working with clients across the fields of cultured meat, cell therapy and biologics. NovoNutrients upcycles industrial carbon dioxide waste into food system ingredients. While Future Meat Technologies has developed a cell-culturing meat technology utilising the rapid growth of connective tissue cells to reach high densities before turning the cells into cultured muscle and healthy fats.

Elsewhere, innovators are looking at how fermentation technologies and bioreactors can be used to create ingredients without depleting natural resources. One of our selected start-ups for 2020, Michroma, is a perfect example this Argentinian based company produces next-generation natural ingredients in a sustainable, cost-effective and scalable way to brew food colorants, mycoprotein and more alternatives, Greven noted.

The 45 selected startups hail from 15 countries, including the US, Australia, Canada, the UK, Argentina, Brazil, Chile, India, Israel, Nigeria, Norway, Peru, Singapore, South Korea and Switzerland.

Consumer food and beverage (CPG):

Food and beverage products made with upcycled ingredients are a top trend among FoodBytes! 2020 CPG startups, who are also pioneering innovations including edible spoons to reduce plastic waste, a distilled spirit made from upcycled whey byproduct, and plant-based cheese and egg products.

Food tech:

The shortlisted food tech startups have developed technologies for cell-based meat production, natural coatings that extend produce shelf life, and sustainable, antimicrobial packaging made from crustacean shells to replace plastic. Food safety technologies, advanced nutrition products and online marketplaces also address relevant needs in the wake of COVID-19.

Ag tech:

The shortlisted ag tech startups have developed solutions that address soil and water sustainability, farm efficiency and labour needs. Their innovations include technology that transforms air pollution into fertilizer, animal feed that reduces methane emissions, a method of growing rice out of water and on-farm robotics to combat labour shortages and worker safety concerns.

Each of the three winners (CPG, food tech, and ag tech) will receive a $10,000 prize, while FoodBytes! Pitch corporate members will also offer additional consulting to support winning startups, including:

See the original post here:
Digitalisation, distribution and biotech: Rabobank talks next gen food tech innovation - FoodNavigator.com

Bruce Power and the Town of Saugeen Shores are working with researchers from the University of Guelph to learn more about the challenges and opportunities facing employers and people working or looking for work in Saugeen Shores.

As COVID-19 has added new difficulties to the challenges many were already facing in the local labour market, this research project will help provide critical considerations and recommendations to the Town of Saugeen Shores and local employers to support future investments and programming to support the local economy.

"Council looks forward to the results of this study as we explore evidence-based solutions to challenges faced by employers and job seekers," said Mayor Luke Charbonneau. "We encourage residents and non-residents to take part and share their experiences with the researchers."

"We are proud that our Life Extension Program is creating unprecedented opportunity in our community, however, opportunity and challenge often ride together and we want to ensure we are doing our part in seizing the opportunities and meeting the challenges and we believe this research will help to achieve that," said John Peevers, Bruce Power's Director of Community, Media Relations and Economic Development.

The research team is currently recruiting participants to share their experiences through interviews. People interested in participating in the project are encouraged to complete a pre-screening process by visiting http://bit.ly/GettingToWork2020.

The Getting to Work research initiative is part of a Mitacs Accelerate Internship being completed by Ashleigh Weeden (PhD Candidate, University of Guelph), funded by Bruce Power and the University of Guelph, and supported by the Town of Saugeen Shores. Mitacs-supported projects support partnerships between academics, industry, and communities to respond to critical challenges and foster a more innovative Canada.

The Getting to Work research initiative is supported by an Advisory Committee composed of local stakeholders and nationally recognized experts in rural research, including:

" Dr. Ryan Gibson - Associate Professor & Libro Professor in Regional Economic Development, School of Environmental Design & Rural Development, University of Guelph

" Heather Hyde - Economic Development Officer, Town of Saugeen Shores

" John Peevers - Director, Community Relations & Economic Development, Bruce Power

" Dr. Karen Foster - Associate Professor, Sociology & Social Anthropology, Canada Research Chair (Tier II) in Sustainable Rural Futures for Atlantic Canada, and Director, Rural Futures Research Centre, Dalhousie University

" Gemma Mendez-Smith - Executive Director, Four County Labour Market Planning Board

" Kimberley Inniss-Petersen - Executive Director, Saugeen Shores Chamber of Commerce

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Saugeen Shores, Bruce Power and University of Guelph teaming up for labour survey - 92.3 The Dock (iHeartRadio)

The spotlight remains on the potential of antibody therapies as a possible way out of the COVID-19 pandemic crisis, with the US government investing millions in a hopeful from AstraZeneca and president Donald Trump recovering from coronavirus after receiving a rival therapy from Regeneron.

Thanks to a drug cocktail including Regenerons antibody therapy, Trump says he is back on his feet after becoming infected with the virus around the end of last month.

Trump has hailed the Regeneron therapy as a cure for the virus, but the companys CEO Leonard Schleifer was quick to point out that the scientific evidence is not there to support the claim.

Regenerons therapy is based on two antibodies the company has developed to neutralise the virus.

The thinking is that by having a double therapy, the chances of the virus developing resistance to both parts of the drug are reduced.

Like rivals Eli Lilly, Regeneron is in talks with the FDA to get an Emergency Use Authorisation based on the data it has gathered so far.

But CEO Leonard Schleifer said in a TV interview that there is a long way to go before the drug is fully approved.

Schleifer told CBS News Face the Nation: So the presidents case is a case of one, and thats what we call a case report, and it is evidence of whats happening, but its kind of the weakest evidence that you can get.

The real evidence has to come about how good a drug is and what it will do on average has to come from these large clinical trials.

Its just low down on the evidence scale that we really need.

Regeneron CEO Leonard Schleifer

Antibody therapies could also be used prophylactically, to protect people at high risk of getting the disease such as healthcare workers, or vulnerable people in areas where there are large numbers of cases.

AstraZeneca is to begin phase 3 trials of a long-acting antibody therapy combination in the US and other countries, to prevent infection happening and as therapy for those already infected.

AZs long-acting antibody (LAAB) combination, AZD7442, will advance into two phase 3 clinical trials in more than 6,000 participants at sites in and outside the US in the next few weeks.

The LAABs have been engineered with AstraZenecas proprietary half-life extension technology to increase the durability of the therapy for six to 12 months following a single administration.

The combination of two LAABs is also designed to reduce the risk of resistance developed by the SARS-CoV-2 virus.

The LAABs have been engineered with AstraZenecas half-life extension technology to increase the durability of the therapy for six to 12 months following a single shot.

Like Regenerons therapy the combination of two LAABs is also designed to reduce the risk of resistance developed by the SARS-CoV-2 virus.

The US government agency, the Biomedical Advanced Research and Development Authority (BARDA) has invested $486 million in the project.

One trial will test whether AZD7442 can safely and effectively prevent infection in up to 5,000 people, and the second trial will test post-exposure prophylaxis and pre-emptive treatment in around 1,100 people.

AZ is planning additional trials to evaluate AZD7442 in approximately 4,000 patients for the treatment of COVID-19.

The company plans to supply up to 100,000 doses starting towards the end of 2020 and the US Government can acquire up to an additional one million doses in 2021 under a separate agreement.

Visit link:
Spotlight on COVID-19 antibody therapies after Trump's recovery - - pharmaphorum

Classification society DNV GL and FPSO specialist Bluewater are undertaking a pilot project to use hybrid digital twin technology to predict and analyse fatigue in the hull of an FPSO in the North Sea.

The project aims to validate and quantify the benefits of creating a virtual replica of the FPSO to optimise the structural safety of the vessel and enhance risk-based inspection (RBI), a decision-making methodology for optimising inspection regimes. The pilot underpins Bluewaters mission to take a proactive, responsible approach to safety and environmental care in its operations.

Bluewaters Aoka Mizu FPSO, currently in operation in the Lancaster field, west of Shetland, will be used. To date, the pilot test has shown encouraging results.

DNV GLs combination of domain experience, inspection capabilities and digital analytics and modelling, enables the monitoring of the assets hull structure during operation without dependence on costly routine inspection regimes. Termed Nerves of Steel, the underlying concept permits the use of various data sets (external environmental data or local sensor data) combined with digital models of the asset, to develop a hybrid replica model of the vessels structure. This can be used in real-time to monitor the assets condition, identify and monitor high risk locations, and plan targeted and cost-efficient maintenance and inspection activities.

Hybrid twin technology uses a combination of numerical design models and data from actively recorded strain gauge sensors on board the FPSO. These sensors allow for a full understanding of the accumulative loading and current state of the FPSO structure. The technology blends computer-simulated modelling with real-time data, which is then streamed to the operator via DNV GLs Veracity data platform or an existing data transfer solution.

By informing and enhancing the RBI process, operators can reduce operational costs and time, providing significant improvements in safety, thereby extending the lifespan and integrity of assets. With fluctuating oil price and the impact of Covid-19 on travel, delivering a mirror image of an asset from the safety of shore needs to be trusted and of value, said Koheila Molazemi, Technology and Innovation Director, DNV GL Oil & Gas.

DNV GLs visual dashboard presents data to Bluewater on stresses in the hulls structure, alongside information that can be used to identify areas with relative higher risk of cracks or deformities to occur. The information, which is constantly recorded, can be accessed and analysed to inform decision-making and implement inspection based on risk priority.

The trial will expand on traditional FPSO integrity management strategies, which are based on software-based assumptions made at the design stage as well as current inspection record to enhance RBI decision-making. The pilot with Bluewater is expected to provide new insight and smarter ways of managing risks and costs related to structural integrity management.

This is DNV GLs third pilot project evaluating the performance of hybrid digital twin technology. With global support from the advisors experts in Singapore, the UK and Norway, the first involved defining a repair procedure for a FPSO flare tower. Another trial, which is still ongoing, is being performed on a fixed offshore platform.

Like an insurance policy, the hybrid digital twin can potentially save millions by avoiding the costly and possibly catastrophic repercussions of ill-informed integrity management by pre-empting and preventing detrimental damage. For an asset operating in a harsh environment, where the loads play an important part in the possible degradations of the asset, using data from the site as a basis for optimised inspection planning, alarms for extreme events and asset suitability for life extension is crucial, added Francois-Xavier Sireta, Technical Lead for Naval Architecture and Principal Engineer, DNV GL Oil & Gas.

Peter van Sloten, Department Head Technology Management, Bluewater said, We decided to extend our digital twin programme to include our FPSO Aoka Mizu. Our ambition for the structures largely matched with the novel digitalisation services of DNV GL. We are therefore pleased to team up with DNV GL to develop a tool to monitor the structural integrity of this most versatile FPSO, designed and proven to operate in harsh environments with high uptimes and a maintained, strict regulatory and safety regime. This will enhance the safety and enables an optimised inspection regime.

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DNV GL and Bluewater to use digital twin to analyse FPSO fatigue - ShipInsight

I am a clinical immunologist that happens to also be a stem cell scientist with 45 years of experience. The first CD34 bone marrow transplantation in 1978 was done at Roswell Park using FACS flow cytometry. We watch GvHD take hold to many leukemia patients to these brave patients trying to save their life with no way to treat them, until now with MSC (mesenchymal stem cells).

I watched many patients give their lives to science research for a chance of cures, which we had successes 40 years forward, if you get CML, CLL you have 98% of treatment or cure. CAR T and other treatments etc.

My concerns (are that) the media is presenting a perspective in vacuum of the stem cell world in California. Prop 71 put California in play and pushed embryonic research. The people of California need to protect their investment of $3.3 billion, or the industry leadership will be lost along with the clinical trials supported by CIRM. Please do not underestimate the RPE for blindness. #1 unmet medical need when the Japanese pharma Astellas bought Ocata in 2015 and put it on the shelf setting back embryonic research.

Lets look at say, Mesoblast, a Australian stem cell company and the leader in field with four studies. (They) had a setback recently of their BLA of SR aGvHD for kids under 12 years old (which is a death sentence) using MSC stem cells (approved for treatment in Japan for two years now) on the first stem cells for regenerative medicine to be approved the FDA, on Sept. 30, 2020. Mesoblast has 330 double blind studies for Covid19 treatment.

We will know before Christmas if FDA will approve these cells. MSC will be better than vaccinations, with super antigens stimulating the immune memory cells being develop by many companies and Federal government.

Two points: federal funding for embryonic research is not very well supported, and you cannot put a price tag on the patients who are willing to put their life on the line for hope and a chance.

Stay in the game California - do not be shortsighted.

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Yes on 14 | Mailbox | independentnews.com - Livermore Independent

Indias first saviour sibling experiment is a success, say doctors.

A one-year-old sibling has saved her brothers life by donating her bone marrow. Kavya was conceived by her parents through invitro fertilisation to save her brother, Abhijeet Solanki, who was born with Thalassemia.

Thalassemia is a disorder where the haemoglobin count is low in blood and such persons require frequent blood transfusions.

Abhijeet was born in November 2013 but unlike normal babies he did not achieve the growth milestones. The parents learned that Abhijeet had Thalassemia major. Abhijeet required blood transfusions every 25 days and the gap between two transfusions reduced as he grew. By the age of six Abhijeet had undergone 80 transfusions, recalled his father Sahdev Singh Solanki. The only way to save him was through a bone marrow transplant.

The family was willing to donate their bone marrow but the human leukocyte antigen (HLA) of the family, including that of his older sister, did not match.

The Solanki family consulted many doctors. Mr. Solankis research led him to the saviour sibling concept following which he sought out Manish Banker, medical director of Nova IVF Fertility in Ahmedabad.

Dr. Banker said Mr. Solankis research and the science behind it was known but nobody had approached him with such a request before.

Dr. Banker started the assisted reproductive therapy, called pre-implantation genetic testing, for monogenic disorder with HLA matching. The couple underwent three cycles of IVF and 18 embryos were created. Of this only one perfectly matched Abhijeets HLA. The embryo was implanted in Apla Solanki, who delivered a baby girl a year ago.

We had to wait for the baby to grow. She had to weigh 10 kg before we could draw bone marrow, said Deepa Trivedi, programme director of Sankalp Bone Marrow Unit, CIMS Hospital, Ahmedabad.

Pointing out that the best therapeutic option for Thalassemia major patients is bone marrow transplant from an HLA-identical donor, Dr. Banker said, We are extremely thrilled to be part of reproductive history in India to create the first-ever saviour-sibling through ART. We used pre-genetic diagnosis and screening test, an established method for conceiving a child who may donate cord blood or hematopoietic stem cells for transplantation to save a critically ill sibling.

Mr. Solanki said the transplant was done on March 17. Since then Abhijeet has not needed any blood transfusion, indicating that he had been cured of the disorder. His haemoglobin count was 11.3, Dr. Trivedi said.

See the article here:
A sister born to save ailing brother - The Hindu

Every 20 minutes someone in the UK is diagnosed with blood cancer and the register of stem cell donors who are needed to save thousands of patients lives does not currently meet the demand. Only 1 in 3 patients will find a donor match within their family and so every year over 2,000 people in the UK are left searching for a matching blood stem cell donor each year.

Blood cancer patients from Black, Asian or minority ethnicity groups face lower survival odds due to the lack ofdonordiversity. These patients have just a 20% chance of finding the best possible stem cell donor match, compared to 69% for northern European backgrounds.

This is due in part to the low numbers of donors registered from those Black, Asian or ethnic minority backgrounds. Donors from minority ethnic backgrounds make up just 13.1% of the UK stem cell register and because Black, Asian or ethnic minority patients tend to have more varied tissue meaning there is an even more specific biological requirement needed of a donor than for a white patient.

The global pandemic has made this situation even worse. Only 2% of stem cell registrations with DKMS came from black people during lockdown, falling by 20% compared to the same time the previous year.

Vaughn Scott is a patient who received a lifesaving donation from a stranger.

Vaughn Scott (34 years old) lives in Bristol and is grateful to the generous stranger who helped save his life. Theyve given him more time with his two children and the chance to marry his now wife last summer in a beautiful ceremony. Vaughn was incredibly fit and active, playing all kinds of sports and serving in the Navy. It was whilst on deployment across the world that he was urgently flown back to the UK and shockingly diagnosed with acute lymphoblastic leukaemia (ALL).

Vaughn said:

Hearing the diagnosis was the biggest blow Ive ever heard. My mind raced straight to my children and partner. When we learnt there was a way I could go into remission, I was excited that there was a way I could get better but very nervous too. With no family members as a match, all my faith was in a complete stranger that may have registered as a potential stem cell donor. Thankfully my match was found, Im now married and enjoying life with my family and Im so grateful. So many people arent as lucky as me. If you can, please register and give other people the second chance at life that I have been given.

To request a swab kit and register as a potential donor click HERE.

About blood cancer

Blood cancer is the third most common cause of cancer death in the UK but there is a lot of fear around stem cell donation of the process itself and of having a depleted supply of stem cells. This isnt the case. After donation, stem cells regenerate within 2 weeks so the donor wont lose anything. Blood stem cell donation is easy to do and similar to blood donation. Around 90% of all donations are made through a method called peripheral blood stem cell (PBSC). In this method, blood is taken from one of the donors arms and a machine extracts the blood stem cells from it. The donors blood is then returned to them through their other arm. This is an outpatient procedure that is usually completed in 4-6 hours. In just 10% of cases, donations are made through bone marrow collection. This is under general anaesthetic so that no pain is experienced.

See the article here:
Black History Month The struggle to find a lifesaving stem cell donor - Keep the Faith

Glancy Prongay & Murray LLP ("GPM") reminds investors of the upcoming December 7, 2020 deadline to file a lead plaintiff motion in the class action filed on behalf of investors who purchased or otherwise acquired Mesoblast Limited ("Mesoblast" or the "Company") (NASDAQ: MESO) securities between April 16, 2019 and October 1, 2020, inclusive (the "Class Period").

If you suffered a loss on your Mesoblast investments or would like to inquire about potentially pursuing claims to recover your loss under the federal securities laws, you can submit your contact information at https://www.glancylaw.com/cases/mesoblast-limited/. You can also contact Charles H. Linehan, of GPM at 310-201-9150, Toll-Free at 888-773-9224, or via email at shareholders@glancylaw.com to learn more about your rights.

Mesoblast develops allogeneic cellular medicines using its proprietary mesenchymal lineage cell therapy platform. Its lead product candidate, RYONCIL (remestemcel-L), is an investigational therapy comprising mesenchymal stem cells derived from bone marrow. In February 2018, the Company announced that remestemcel-L met its primary endpoint in a Phase 3 trial to treat children with steroid refractory acute graft versus host disease ("aGVHD").

In early 2020, Mesoblast completed its rolling submission of its Biologics License Application ("BLA") with the FDA to secure marketing authorization to commercialize remestemcel-L for children with steroid refractory aGVHD.

On August 11, 2020, the FDA released briefing materials for its Oncologic Drugs Advisory Committee ("ODAC") meeting to be held on August 13, 2020. Therein, the FDA stated that Mesoblast provided post hoc analyses of other studies "to further establish the appropriateness of 45% as the null Day-28 ORR" for its primary endpoint. The briefing materials stated that, due to design differences between these historical studies and Mesoblasts submitted study, "it is unclear that these study results are relevant to the proposed indication."

Story continues

On this news, the Companys share price fell $6.09, or approximately 35%, to close at $11.33 per share on August 11, 2020, on unusually heavy trading volume.

On October 1, 2020, Mesoblast disclosed that it had received a Complete Response Letter ("CRL") from the FDA regarding its marketing application for remestemcel-L for treatment of SR-aGVHD in pediatric patients. According to the CRL, the FDA recommended that the Company "conduct at least one additional randomized, controlled study in adults and/or children to provide further evidence of the effectiveness of remestemcel-L for SR-aGVHD." The CRL also "identified a need for further scientific rationale to demonstrate the relationship of potency measurements to the products biologic activity."

On this news, the Companys stock fell $6.56, or 35%, to close at $12.03 per share on October 2, 2020, on unusually heavy trading volume.

The complaint filed in this class action alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Companys business, operations, and prospects. Specifically, Defendants failed to disclose to investors: (1) that comparative analyses between Mesoblasts Phase 3 trial and three historical studies did not support the effectiveness of remestemcel-L for steroid refractory aGVHD due to design differences between the four studies; (2) that, as a result, the FDA was reasonably likely to require further clinical studies; (3) that, as a result, the commercialization of remestemcel-L in the U.S. was likely to be delayed; and (4) that, as a result of the foregoing, Defendants positive statements about the Companys business, operations, and prospects were materially misleading and/or lacked a reasonable basis.

Follow us for updates on LinkedIn, Twitter, or Facebook.

If you purchased or otherwise acquired Mesoblast securities during the Class Period, you may move the Court no later than December 7, 2020 to ask the Court to appoint you as lead plaintiff. To be a member of the Class you need not take any action at this time; you may retain counsel of your choice or take no action and remain an absent member of the Class. If you wish to learn more about this action, or if you have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Charles Linehan, Esquire, of GPM, 1925 Century Park East, Suite 2100, Los Angeles California 90067 at 310-201-9150, Toll-Free at 888-773-9224, by email to shareholders@glancylaw.com, or visit our website at http://www.glancylaw.com. If you inquire by email please include your mailing address, telephone number and number of shares purchased.

This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201015005282/en/

Contacts

Glancy Prongay & Murray LLP, Los AngelesCharles H. Linehan, 310-201-9150 or 888-773-92241925 Century Park East, Suite 2100Los Angeles, CA 90067www.glancylaw.com shareholders@glancylaw.com

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Glancy Prongay & Murray LLP Reminds Investors of Looming Deadline in the Class Action Lawsuit Against Mesoblast Limited (MESO) - Yahoo Finance

HAIFA, Israel, Oct. 13, 2020 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological products, today announced that it has received clearance from the safety committee of an investigator initiated Phase I/II study to move forward with patient enrollment for cohort II. The study will evaluate PLX-PAD cells in the treatment of steroid-refractory chronic graft vs. host disease (GvHD) and is led by Principal Investigator Prof. Ron Ram, Director of the Hematology Blood and Marrow Stem Cell Transplantation Unit at Tel Aviv Sourasky Medical Center, Ichilov Hospital, Israel. Prof. Ram and his research staff are responsible for the design and implementation of the study at Sourasky Medical Center.

GvHD is a severe complication in patients who have undergone an allogeneic hematopoietic cell transplantation (HCT) and is a major cause of morbidity and mortality in these patients in which the donated stem cells identify the recipient's body as foreign and attack it. The chronic form of GvHD (cGvHD) usually appears later than 100 days post-transplant.

Cohort I included 6 patients treated with 2 injections of 150 million cells, a week apart. At the 3-month follow up, interim safety results concluded that PLX-PAD cells were safe and that no treatment related side effects were reported. Efficacy results demonstrated that 4 out of the 6 patients reported improvement in symptoms that translated into a reduction in the severity of cGvHD with notable reduction in the required steroid doses for part of the patients. Based on these results, the study was approved to commence enrollment of 14 patients in cohort II to be treated with 4 injections of 150 million cells.

Prof. Ram of Ichilov Hospital commented, From our experience in having treated 6 patients in the study to date, we have so far found no negative side effects from the use of the PLX-PAD cells in the treatment of steroid-refractory cGvHD. Patients with significant GvHD skin disorders previously unresponsive to multiple types of therapy showed remarkable response. Responses were also observed for severe mouth ulcers which prevented patients from eating solid foods. This resulted in a major improvement of quality of life and tapering of steroid doses."

Pluristem is committed to contributing to the wellbeing and quality of life of our patients. cGvHD is an indication where we see a significant need to enhance the current course of treatment for this life-threatening condition among patients undergoing bone marrow transplants. The preliminary results from cohort I of this Phase I/II study, and prior preclinical data, both indicate that PLX-PAD cells may potentially treat cGvHD patients and mitigate symptoms. We are very pleased to cooperate with Prof. Ram and Sourasky Medical Center, and we place a high importance in examining PLX-PAD for this indication, stated Pluristem CEO and President, Yaky Yanay.

About cGvHDChronic graft-versus-host disease (cGvHD) remains a common and potentially life-threatening complication of allogeneic hematopoietic stem cell transplantation (HCT). The 2-year cumulative incidence of chronic GvHD requiring systemic treatment is 30% to 40% by National Institutes of Health criteria1. The hematopoietic stem cell transplants are used to treat bone marrow failure resulting from treatment of some blood or bone marrow cancers as well as other hematologic failures, such as aplastic anemia, which are not related to cancer. The donated cells identify the recipients body as foreign and attack it as a result. While acute GvHD usually appears in the first 100 days after a transplant, and in specific body systems, chronic GvHD can occur at any time (even several years) after a transplant, and may manifest in many parts of the body such as: skin, mouth, eyes, liver, intestines, lungs and joints. Long term immunosuppression is given to try to prevent or treat cGvHD. Since this treatment suppresses the immune system for a very long time, patients are at high risk of infections, and are prescribed multiple medications to try to address this major risk.

About Pluristem TherapeuticsPluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy product candidates. The Company has reported robust clinical trial data in multiple indications for its patented PLX cell product candidates and is currently conducting late stage clinical trials in several indications. PLX cell product candidates are believed to release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders and radiation damage. The cells are grown using the Company's proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching. Pluristem has a strong intellectual property position; a Company-owned and operated GMP-certified manufacturing and research facility; strategic relationships with major research institutions; and a seasoned management team.

Safe Harbor StatementThis press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws. For example, Pluristem is using forward-looking statements when it discusses the patient enrollment for cohort II for its Phase I/II study of its PLX-PAD cells, the implication from the results of the first patient cohort in the study, the belief that GvHD is an indication that has a significant need for enhanced treatments among patients undergoing bone marrow transplants and that the preliminary results from cohort I of the study, and the prior preclinical data, indicate that PLX-PAD cells may potentially treat chronic GvHD patients and mitigate symptoms. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem 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. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristems products may not be approved by regulatory agencies, Pluristems technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristems process; Pluristems products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristems patents may not be sufficient; Pluristems products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem's reports filed from time to time with the Securities and Exchange Commission.

Contact:

Dana RubinDirector of Investor Relations972-74-7107194danar@pluristem.com

_________________________________

1 Flowers ME, Martin PJ. How we treat chronic graft-versus-host disease. Blood. 2015 Jan 22;125(4):606-15. doi: 10.1182/blood-2014-08-551994. Epub 2014 Nov 14. PMID: 25398933; PMCID: PMC4304105., https://pubmed.ncbi.nlm.nih.gov/25398933/

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Pluristem Announces Clearance to Move Forward with Enrollment for Cohort II in an Investigator-Led Phase I/II Chronic Graft vs Host Disease...

Gosselies, Belgium, 14 October 2020, 7am CEST BONE THERAPEUTICS(Euronext Brussels and Paris: BOTHE), the cell therapy company addressing unmet medical needs in orthopedics and other diseases, today announces positive 24-month follow-up results for the Phase IIa study with the allogeneic cell therapy product, ALLOB, in patients undergoing lumbar spinal fusion procedures.

The 24-month data show a high percentage of successful lumbar vertebrae fusion of 90%. Patients also continue to experience important clinical improvements in function and pain, from as early as six months after treatment, up to the 24-month follow-up period.

Degenerative spine disorders have a major impact on the quality of life of patients. These impacts include decreases in the stability of the spine and pain in motion,said Dr. Alphonse Lubansu, M.D., Head of the Spinal Clinic, Erasme University Hospital, Universit libre de Bruxelles. The 24 month follow-up data of this Phase IIa clinical trial have demonstrated that patients treated with ALLOB in spinal fusion procedure show a high incidence in fusion, and benefit from a sustained, clinically meaningful improvement in function and pain throughout the 24 months following treatment together with a good safety profile. These results show that ALLOB in combination with the standard spine fusion surgery could be a promising treatment option to address the currently unmet needs of these patients.

This positive data forlumbar spinal fusion complementsthe strong Phase I/IIa results from ALLOB in patients with delayed union fractures,said Miguel Forte, MD, PhD, Chief Executive Officer of Bone Therapeutics. These studies provide promising clinical evidence for the potential ofBone Therapeuticsunique allogeneic cell therapy platform to address high unmet medical needs in orthopaedics and bone related disorders. We will now hold discussions with global regulators and our partners to explore a variety of options for the next stages of clinical development for ALLOB in different orthopedic indications, while pursuing the phase IIb study of ALLOB in difficult tibial fractures.In addition, theclinical results provide further evidence for the expansion of ALLOB and our platform of differentiated MSCs to other indications.

The multi-center, open-label proof-of-concept Phase IIa study was designed to evaluate the safety and efficacy of ALLOB administered, procedure in which an interbody cage with bioceramic granules mixed with ALLOB is implanted into the spine to achieve fusion of the lumbar vertebrae. The main endpoints of the 24-month follow-up analysis included safety and radiological assessments to evaluate vertebrae fusion (continuous bone bridges) and clinical assessments to evaluate improvement in patients functional disability as well as reduction in back and leg pain. The study evaluated 30 patients treated with ALLOB, 29 patients attended the 24-month visit.

Radiological data was collected from CT-scans at 24 months and assessed by three external readers. It showed a successful fusion of the lumbar vertebrae in 27 out of 30 patients (90%). In addition, the remaining 3 patients showed radiological evidence of bone formation. Treatment with ALLOB also resulted in a clear and statistically significant clinical improvement in function and reduction in pain over the 24-month follow-up period. Functional disability improved from the pre-treatment baseline to 24-month by a mean score of 60% (p<0.001) on the Oswestry Disability Index(1). Back and leg pain were strongly reduced by 57 to 62% (p<0.001) and 68 to 70% (p<0.001) respectively compared to pre-treatment baseline. Treatment with ALLOB was generally well-tolerated by the patients, consistent with previous reported results.

(1)The Oswestry Disability Index (ODI) is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to measure a patients permanent functional disability. This validated questionnaire was first published by Jeremy Fairbank et al. in Physiotherapy in 1980. ODI score of 0%-20%: minimal disability; 21%-40%: moderate disability; 41%-60%: severe disability; 61%-80%: crippled; 81%-100%: bed bound.

About Spinal Fusion

Due to ageing populations and sedentary lifestyles, the number of people suffering from degenerative spine disorders continues to increase. Today, spinal fusion procedures are performed to relieve pain and improve patient daily functioning in a broad spectrum of degenerative spine disorders. Spinal fusion consists of bridging two or more vertebrae with the use of a cage and graft material, traditionally autologous bone graft or demineralised bone matrix placed into the intervertebral space for fusing an unstable portion of the spine and immobilizing a painful intervertebral motion segment. Over 1,000,000 spinal fusion procedures are performed annually in the US and EU, of which half at lumbar level and the market is growing at a rate of 5% per year. Although spinal fusion surgery is routine, non-fusion, slow progression to fusion and failure to eliminate pain are still frequent with up to 35% of patients not being satisfied with their surgery.

About ALLOB

ALLOB is the Companys off-the-shelf allogeneic cell therapy platform consisting of human allogeneic bone-forming cells derived from cultured bone marrow mesenchymal stem cells (MSC) from healthy adult donors, offering numerous advantages in product quality, injectable quantity, production, logistics and cost as compared to an autologous approach. To address critical factors for the development and commercialisation of cell therapy products, Bone Therapeutics has established a proprietary, optimised production process that improves consistency, scalability, cost effectiveness and ease of use of ALLOB. This optimized production process significantly increases the production yield, generating 100,000 of doses of ALLOB per bone marrow donation. Additionally, the final ALLOB product will be cryopreserved, enabling easy shipment and the capability to be stored in a frozen form at the hospital level. The process will therefore substantially reduce overall production costs, simplify supply chain logistics, improve patient accessibility and facilitate global commercialisation. The Company will implement the optimized production process for all future clinical trials with ALLOB.

About Bone Therapeutics

Bone Therapeutics is a leading biotech company focused on the development of innovative products to address high unmet needs in orthopedics and other diseases. The Company has a, diversified portfolio of cell and biologic therapies at different stages ranging from pre-clinical programs in immunomodulation to mid-to-late stage clinical development for orthopedic conditions, targeting markets with large unmet medical needs and limited innovation.

Bone Therapeutics is developing an off-the-shelf next-generation improved viscosupplement, JTA-004, which is currently in phase III development for the treatment of pain in knee osteoarthritis. Consisting of a unique combination of plasma proteins, hyaluronic acid a natural component of knee synovial fluid, and a fast-acting analgesic, JTA-004 intends to provide added lubrication and protection to the cartilage of the arthritic joint and to alleviate osteoarthritic pain and inflammation. Positive phase IIb efficacy results in patients with knee osteoarthritis showed a statistically significant improvement in pain relief compared to a leading viscosupplement.

Bone Therapeutics core technology is based on its cutting-edge allogeneic cell therapy platform with differentiated bone marrow sourced Mesenchymal Stromal Cells (MSCs) which can be stored at the point of use in the hospital. Currently in pre-clinical development, BT-20, the most recent product candidate from this technology, targets inflammatory conditions, while the leading investigational medicinal product, ALLOB, represents a unique, proprietary approach to bone regeneration, which turns undifferentiated stromal cells from healthy donors into bone-forming cells. These cells are produced via the Bone Therapeutics scalable manufacturing process. Following the CTA approval by regulatory authorities in Europe, the Company is ready to start the phase IIb clinical trial with ALLOB in patients with difficult tibial fractures, using its optimized production process. ALLOB continues to be evaluated for other orthopedic indications including spinal fusion, osteotomy, maxillofacial and dental.

Bone Therapeutics cell therapy products are manufactured to the highest GMP standards and are protected by a broad IP (Intellectual Property) portfolio covering ten patent families as well as knowhow. The Company is based in the BioPark in Gosselies, Belgium. Further information is available atwww.bonetherapeutics.com.

For further information, please contact:

Bone Therapeutics SAMiguel Forte, MD, PhD, Chief Executive OfficerJean-Luc Vandebroek, Chief Financial OfficerTel: +32 (0)71 12 10 00investorrelations@bonetherapeutics.com

For Belgian Media and Investor Enquiries:BepublicCatherine HaquenneTel: +32 (0)497 75 63 56catherine@bepublic.be

International Media Enquiries:Image Box CommunicationsNeil Hunter / Michelle BoxallTel: +44 (0)20 8943 4685neil.hunter@ibcomms.agency / michelle@ibcomms.agency

For French Media and Investor Enquiries:NewCap Investor Relations & Financial CommunicationsPierre Laurent, Louis-Victor Delouvrier and Arthur RouillTel: +33 (0)1 44 71 94 94bone@newcap.eu

For US Media and Investor Enquiries:LHA Investor RelationsYvonne BriggsTel: +1 310 691 7100ybriggs@lhai.com

Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company or, as appropriate, the Company directors current expectations and projections about future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such persons officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

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Bone Therapeutics' allogeneic cell therapy product, ALLOB, shows 90% fusion rate at 24 months in Phase IIa study in lumbar spinal fusion -...

Building on the transformative impetus from the first Food and Drug Administration (FDA)-approved Janus kinase (JAK) 1/2 inhibitor, ruxolitinib (Jakafi), in the clinical landscape of myeloproliferative neoplasms (MPNs), we are entering a new era of multiple JAK inhibitors and other diverse classes of drugs in rapid clinical development. Advancements in elucidating the pathophysiology of MPNs have spurred significant progress in developing novel promising agents or combination regimens with ruxolitinib to treat patients who are unresponsive to standard treatments or have specific clinical needs.

In myelofibrosis (MF), the most aggressive MPN, with an average survival of 5 to 7 years, abnormal clonal hematopoietic stem cell proliferation in the bone marrow (BM) leads to liberation of pro-inflammatory cytokines and extensive fibrosis, causing progressive pancytopenia, especially anemia and thrombocytopenia, along with splenomegaly and other symptoms, compromising quality of life.1

For nearly a decade, ruxolitinib has been the centerpiece therapy for patients with MF, markedly improving splenomegaly and constitutional symptoms and providing survival benefit.2 The second FDA-approved JAK2 inhibitor, fedratinib (Inrebic), may actually be a good second-line option for patients who are ruxolitinib-resistant with intermediate-2 and high-risk MF (primarily thrombocytopenic and characterized by platelet counts 50100 109/L).3 At present, 2 ongoing phase 3 clinical trials, the single-arm FREEDOM trial (NCT03755518) and the double-arm FREEDOM 2 trial (NCT03952039), are assessing the efficacy and safety of fedratinib in patients with MF who are resistant/refractory/intolerant to ruxolitinib. The FREEDOM trials are important because the previous JAKARTA studies (NCT01523171, NCT01437787) were placed on hold or terminated given concerns for the development of Wernicke encephalopathy. Pacritinib is a potent inhibitor of both JAK2 and fms-related receptor tyrosine kinase

3, or FLT3, but does not affect JAK1. Pacritinib is being evaluated in comparison with the physicians choice in an ongoing phase 3 trial (PACIFICA; NCT03165734) in patients with MF and severe thrombocytopenia (baseline platelet count < 50 109/L) at the optimal dose determined in the PAC203 study (200 mg twice daily; NCT03165734).3 Successful clinical development of pacritinib will provide a non-myelosuppressive JAK2 inhibitor for frontline treatment of patients with MF who have severe thrombocytopenia, a setting currently lacking approved drugs. Another JAK1/2 inhibitor that is in advanced clinical development and complements its predecessors is momelotinib, possessing the exclusive attribute to improve anemia, which becomes severe in patients with MF.3 At present, momelotinib is undergoing evaluation in patients who are symptomatic and anemic with advanced MF, previously treated with a JAK inhibitor, in a phase 3 trial (MOMENTUM; NCT04173494); the comparator drug is danazol.

Targeting anemia and thrombocytopenia. Given that patients with MF experience disease-associated and JAK inhibitor-induced anemia, several clinical trials have been evaluating drugs counteracting anemia, as monotherapies or in combination with ruxolitinib, in patients with MF-associated anemia.4 Currently, a global, multicenter phase 2 trial is under way to evaluate the safety and efficacy of luspatercept-aamt (Reblozyl), an activin receptor ligand trap that enhances late-stage erythropoiesis in patients with anemia and MF, including ruxolitinib-treated, transfusion-dependent individuals; a phase 3 trial (INDEPENDENCE) is planned for 2020. Interim results of the phase 2 study demonstrated significant efficacy of luspatercept-aamt, achieving reduction in red blood cell transfusion burden in ruxolitinib-treated patients with MF. Thalidomide (Thalomid), an immunomodulatory agent, significantly improved anemia and thrombocytopenia (platelet counts increased in 60% of patients) in a phase 2 trial evaluating ruxolitinib-treated patients with MF and baseline thrombocytopenia (NCT03069326).5

Synergistic combinations with ruxolitinib targeting epigenetics and JAK2 (TABLE). CPI-0610 is a selective bromodomain and extraterminal protein inhibitor that improved spleen volume, anemia, BM fibrosis, total symptom score, and transfusion dependence (alone or with ruxolitinib) in patients with MF who are enrolled in the global phase 2 MANIFEST study (NCT02158858).3 Furthermore, a phase 1 clinical trial combining an inhibitor of heat shock protein 90 (JAK2 is its chaperone protein), PU-H71, with ruxolitinib in patients with primary/secondary MF is under way (NCT03935555).3 The previous 2 trials are supported by preclinical data showing drug synergism. In a phase 2 trial of ruxolitinib/azacitidine (hypomethylating agent) in patients with MF, synergism was demonstrated in spleen length reduction and BM fibrosis improvement compared with ruxolitinib monotherapy (NCT01787487).5

Synergistic combinations with ruxolitinib targeting antiapoptotic proteins and JAK2. Navitoclax is an orally bioavailable inhibitor of the antiapoptotic B-cell lymphoma 2 (BCL2) family of proteins (primarily BCL extra-large [XL]). In preclinical studies, the nonclinical analogue of navitoclax, ABT-737, in combination with ruxolitinib showed synergism in inducing apoptosis of JAK2 V617F-driven MPN cell lines. Interim data from an ongoing phase 2 clinical trial evaluating navitoclax in combination with ruxolitinib in ruxolitinib-treated patients with MF (with baseline platelet count 100 109/L) showed reduction in spleen volume and BM fibrosis (1 grade) and improvement in total symptom score in a proportion of the patients (NCT03222609).3

Imetelstat is a short oligonucleotide telomerase inhibitor that possibly prolonged median overall survival in patients with MF in the higher-dose (9.4-mg/kg) arm of the phase 2 IMbark study (NCT02426086).3 A phase 3 trial comparing imetelstat to best available therapy in patients with refractory MF is planned for early 2021.

PRM-151, a plasma-derived analogue of the human antifibrotic protein pentraxin 2, improved BM fibrosis in mice models and patients with MF in preclinical and phase 1/2 clinical studies, respectively.3 The promising results merit a phase 3 trial, especially given the scarcity of antifibrotic agents.

The two relatively indolent MPN subtypes, polycythemia vera (PV) and essential thrombocythemia (ET), are characterized by abnorabnormal proliferation of myeloid cells, resulting in elevated blood counts (erythrocytosis and thrombocytosis in PV and ET, respectively), considerable risk of thrombosis and hemorrhage, and progression to secondary MF and acute myeloid leukemia (more common in PV than ET).6 In PV and ET, therapies are aimed at reducing risk of thrombosis, which is higher in patients over 60 years old or with a history of thrombosis, and in ET, when the calreticulin gene, CALR, is absent. A particularly promising agent for the two indolent MPNs is the long-acting ropeginterferon -2b, which was approved in Europe for frontline treatment of high-risk patients with PV and without symptomatic splenomegaly on the basis of the PROUD/CONTINUATION-PV studies [EudraCT, 2012-005259-18 (PROUD-PV) and 2014-001357- 17 (CONTINUATION-PV)].7 The previous investigations demonstrated superiority of ropeginterferon -2b versus hydroxyurea after 3 years of therapy. Besides awaiting possible approval of ropeginterferon -2b to treat patients with PV in the United States, a phase 3 trial of ropeginterferon -2b versus anagrelide in hydroxyurea-resistant/intolerant patients with ET has been planned to start in 2020. Givinostat, an inhibitor of histone deacetylases, demonstrated promising clinical responses (reduction in pruritus and thrombosis, and normalization of hematological parameters) in phase 1/2 studies in patients with JAK2 V617F positive PV and is entering a phase 3 trial in 2021.7 Currently, hydroxyurea and ruxolitinib are the first- and second-line treatments for high-risk patients with PV, respectively, and hydroxyurea is the first-line treatment for ET.

Herein we highlighted an array of drugs ranging from new JAK inhibitors to an antifibrotic agent, epigenetic modifiers, and telomerase and BCL-XL/BCL2 inhibitorsthat are in early or advanced clinical development in MPN. We are looking forward to enrichment of the MPN arsenal with new disease-modifying agents complementing the clinical benefits of ruxolitinib and fulfilling unmet needs in this population.

References:

1. Verstovsek S, Gotlib J, Mesa RA, et al. Long-term survival in patients treated with ruxolitinib for myelofibrosis: COMFORT-I and -II pooled analyses. J Hematol Oncol. 2017;10(1):156. doi:10.1186/s13045-017-0527-7

2. Bose P, Verstovsek S. Management of myelofibrosis after ruxolitinib failure. Leuk Lymphoma. Published online April 16, 2020. doi:10.1080/1 0428194.2020.1749606

3. Bose P, Verstovsek S. Management of myelofibrosis-related cytopenias. Curr Hematol Malig Rep. 2018;13(3):164-172. doi:10.1007/s11899- 018-0447-9

3. Bose P, Alfayez M, Verstovsek S. New concepts of treatment for patients with myelofibrosis. Curr Treat Options Oncol. 2019;20(1):5. doi:10.1007/s11864-019-0604-y

4. Bose P, Verstovsek S. Updates in the management of polycythemia vera and essential thrombocythemia. Ther Adv Hematol. 2019;10:2040620719870052. doi:10.1177/2040620719870052

5. Gisslinger H, Klade C, Georgiev P, et al. Ropeginterferon alfa-2b versus standard therapy for polycythaemia vera (PROUD-PV and CONTINUATION-PV): a randomised, non-inferiority, phase 3 trial and its extension study. Lancet Haematol. 2020;7(3):e196-e208. doi:10.1016/S2352- 3026(19)30236-4

6. Chifotides HT, Bose P, Verstovsek S. Givinostat: an emerging treatment for polycythemia vera. Expert Opin Investig Drugs. 2020;29(6):525- 536. doi:10.1080/13543784.2020.1761323

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New Therapies in Development for Myelofibrosis - Targeted Oncology

NEW YORK, Oct. 15, 2020 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of cellular therapies for neurodegenerative diseases, announced today financial results for the third quarter ended September 30, 2020, and provided a corporate update.

"The most important near-term event for BrainStorm will be the upcoming top-line data readout for the NurOwn Phase 3 trial in ALS, expected by the end of November. A successful outcome will set us on the path to filing a Biologic License Application (BLA) for what we believe will be a valuable new treatment for ALS," said Chaim Lebovits, Chief Executive Officer of BrainStorm Cell Therapeutics. "In parallel to our preparations for upcoming data read out, we are very busy planning and executing on other pre-BLA activities. On the management front, we appointed William K. White and Dr. Anthony Waclawski, adding valuable commercial and regulatory expertise to our leadership team. This expertise will be crucial as we work towards obtaining regulatory approval for NurOwn and ensuring that, if approved, it will be readily accessible to ALS patients in need of new treatment options for this devastating disease."

NurOwn has an innovative mechanism of action that is broadly applicable across neurodegenerative diseases and BrainStorm continues to invest in clinical trials evaluating the product in conditions beyond ALS to maximize value creation for its various stakeholders. The company remains on track to complete dosing in its Phase 2 clinical trial in progressive multiple sclerosis (PMS) by the end of 2020. In addition, the Company recently unveiled a clinical development program in Alzheimer's' disease (AD) and is planning a Phase 2 proof-of-concept clinical trial at several leading AD centers in the Netherlands and France.

Third Quarter 2020 and Recent Corporate Highlights:

Presented at the following Investor Conferences:

Cash and Liquidity as of October 14, 2020

Total available funding as of October 14, 2020, which includes cash, cash equivalents and short-term bank deposits of approximately $33.1 million as well as remaining non-dilutive funding from CIRM, IIA and other grants, amounts to approximately $36 million.

Financial Results for the Three Months Ended September 30, 2020

Conference Call & WebcastThursday, October 15, 2020 at 8 a.m. Eastern TimeFrom the US: 877-407-9205International: 201-689-8054Webcast: https://www.webcaster4.com/Webcast/Page/2354/37811

Replays, available through October 29, 2020From the US: 877-481-4010International: 919-882-2331Replay Passcode: 37811

About NurOwn

NurOwn (autologous MSC-NTF) cells represent a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors (NTFs). Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression. BrainStorm has fully enrolled a Phase 3 pivotal trial of autologous MSC-NTF cells for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm also recently received acceptance from the U.S. Food and Drug Administration (FDA) to initiate a Phase 2 open-label multicenter trial in progressive multiple sclerosis (MS) and completed enrollment in August 2020.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has fully enrolled a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six U.S. sites supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm also recently received U.S. FDA clearance to initiate a Phase 2 open-label multicenter trial in progressive multiple sclerosis (MS). The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) completed enrollment in August 2020. For more information, visit the company's website at http://www.brainstorm-cell.com.

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern, regulatory approval of BrainStorm's NurOwn treatment candidate, the success of BrainStorm's product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm's NurOwn treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm's ability to manufacture and commercialize the NurOwn treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm's ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation,; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

ContactsInvestor Relations:Corey Davis, Ph.D.LifeSci Advisors, LLCPhone: +1 646-465-1138cdavis@lifesciadvisors.com

Media:Paul TyahlaSmithSolvePhone: + 1.973.713.3768Paul.tyahla@smithsolve.com

BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIESINTERIM CONDENSED CONSOLIDATED BALANCE SHEETSU.S. dollars in thousands(Except share data)

September 30,

December 31,

2020

2019

U.S. $ in thousands

Unaudited

Audited

ASSETS

Current Assets:

Cash and cash equivalents

$

24,770

$

536

Short-term deposit (Note 4)

4,038

33

Other accounts receivable

1,473

2,359

Prepaid expenses and other current assets (Note 5)

56

432

Total current assets

30,337

3,360

Long-Term Assets:

Prepaid expenses and other long-term assets

27

32

Operating lease right of use asset (Note 6)

1,377

2,182

Property and Equipment, Net

950

960

Total Long-Term Assets

2,354

3,174

Total assets

$

32,691

$

6,534

LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)

Current Liabilities:

Accounts payable

$

3,283

$

14,677

Accrued expenses

917

1,000

Operating lease liability (Note 6)

1,216

1,263

Other accounts payable

1,013

714

Total current liabilities

6,429

17,654

Long-Term Liabilities:

Operating lease liability (Note 6)

284

1,103

Total long-term liabilities

284

1,103

Total liabilities

$

6,713

$

18,757

Stockholders' Equity (deficit):

Stock capital: (Note 7)

12

11

Common Stock of $0.00005 par value - Authorized: 100,000,000 shares at September 30, 2020 and December 31, 2019 respectively; Issued and outstanding: 31,567,592 and 23,174,228 shares at September 30, 2020 and December 31, 2019 respectively.

Additional paid-in-capital

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BrainStorm Announces Financial Results for the Third Quarter of 2020 and Provides a Corporate Update - BioSpace

SAN DIEGO--(BUSINESS WIRE)--Robbins Geller Rudman & Dowd LLP announces that a class action lawsuit has been filed in the Southern District of New York on behalf of purchasers or acquirers of Mesoblast Limited (NASDAQ:MESO) securities between April 16, 2019 and October 1, 2020, inclusive (the Class Period). The case is captioned Kristal v. Mesoblast Limited, No. 20-cv-08430, and is assigned to Judge Philip M. Halpern. The Mesoblast class action lawsuit charges Mesoblast and certain of its executives with violations of the Securities Exchange Act of 1934.

The Private Securities Litigation Reform Act of 1995 permits any investor who purchased Mesoblast securities during the Class Period to seek appointment as lead plaintiff in the Mesoblast class action lawsuit. A lead plaintiff will act on behalf of all other class members in directing the Mesoblast class action lawsuit. The lead plaintiff can select a law firm of its choice to litigate the Mesoblast class action lawsuit. An investors ability to share in any potential future recovery of the Mesoblast class action lawsuit is not dependent upon serving as lead plaintiff. If you wish to serve as lead plaintiff of the Mesoblast class action lawsuit or have questions concerning your rights regarding the Mesoblast class action lawsuit, please provide your information here or contact counsel, J.C. Sanchez of Robbins Geller, at 800/449-4900 or 619/231-1058 or via e-mail at jsanchez@rgrdlaw.com. Lead plaintiff motions for the Mesoblast class action lawsuit must be filed with the court no later than December 7, 2020.

Mesoblast develops allogeneic cellular medicines using its mesenchymal lineage cell therapy platform. Mesoblasts lead product candidate, RYONCIL (remestemcel-L), is an investigational therapy comprising mesenchymal stem cells derived from bone marrow. In February 2018, Mesoblast announced that remestemcel-L met its primary endpoint in a Phase 3 trial to treat children with steroid refractory acute graft versus host disease (SR-aGVHD). In early 2020, Mesoblast completed its rolling submission of its Biologics License Application with the U.S. Food and Drug Administration (FDA) to secure marketing authorization to commercialize remestemcel-L for children with SR-aGVHD.

The Mesoblast class action lawsuit alleges that during the Class Period defendants made false and/or misleading statements and/or failed to disclose that: (1) comparative analyses between Mesoblasts Phase 3 trial and three historical studies did not support the effectiveness of remestemcel-L for SR-aGVHD due to design differences between the four studies; (2) thus, the FDA was reasonably likely to require Mesoblast to conduct further clinical studies; (3) as such, Mesoblasts commercialization of remestemcel-L in the United States was likely to be delayed; and (4) as a result of the foregoing, defendants positive statements about Mesoblasts business, operations, and prospects were materially misleading and/or lacked a reasonable basis.

On August 11, 2020, the FDA released briefing materials for its Oncologic Drugs Advisory Committee meeting revealing that Mesoblast provided post hoc analyses of other studies to further establish the appropriateness of 45% as the null Day-28 overall response rate for its primary endpoint. The briefing materials further stated that, due to design differences between these historical studies and Mesoblasts submitted study, it is unclear that these study results are relevant to the proposed indication. On this news, Mesoblasts share price fell by nearly 35%.

Then, on October 1, 2020, Mesoblast disclosed that it had received a Complete Response Letter (CRL) from the FDA regarding its marketing application for remestemcel-L for treatment of SR-aGVHD in pediatric patients. According to the CRL, the FDA recommended that Mesoblast conduct at least one additional randomized, controlled study in adults and/or children to provide further evidence of the effectiveness of remestemcel-L for SR-aGVHD. The CRL also identified a need for further scientific rationale to demonstrate the relationship of potency measurements to the products biologic activity. On this news, Mesoblasts share price fell an additional 35%, further damaging investors.

Robbins Geller Rudman & Dowd LLP is one of the worlds leading law firms representing investors in securities class action litigation. With 200 lawyers in 9 offices, Robbins Geller has obtained many of the largest securities class action recoveries in history. For seven consecutive years, ISS Securities Class Action Services has ranked the Firm in its annual SCAS Top 50 Report as one of the top law firms in the world in both amount recovered for shareholders and total number of class action settlements. Robbins Geller attorneys have helped shape the securities laws and have recovered tens of billions of dollars on behalf of aggrieved victims. Beyond securing financial recoveries for defrauded investors, Robbins Geller also specializes in implementing corporate governance reforms, helping to improve the financial markets for investors worldwide. Robbins Geller attorneys are consistently recognized by courts, professional organizations, and the media as leading lawyers in the industry. Please visit http://www.rgrdlaw.com for more information.

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Notice of Lead Plaintiff Deadline for Shareholders in the Mesoblast Limited Class Action Lawsuit - Business Wire