NEW YORK, April 08, 2020 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB) today announced that its allogeneic mesenchymal stem cell (MSC) product candidate remestemcel-L will be formally evaluated in a randomized, placebo-controlled trial in 240 patients with acute respiratory distress syndrome (ARDS) caused by coronavirus infection (COVID-19). This multi-center Phase 2/3 trial will be conducted as a public-private partnership in a collaboration with the Cardiothoracic Surgical Trials Network (CTSN), which was established by the United States National Institutes of Healths National Heart, Lung and Blood Institute (NHLBI) as a flexible platform for conducting collaborative trials. Mesoblast holds an Investigational New Drug (IND) Application from the United States Food and Drug Administration (FDA) for use of remestemcel-L in the treatment of patients with COVID-19 ARDS, and will provide investigational product for the trial.
Mesoblast Chief Executive Dr Silviu Itescu stated: This significant public-private partnership is a prime example of how the combined resources of industry and government can be leveraged to evaluate in a most efficient and rigorous manner the potential of innovative therapies to make a meaningful difference to patient outcomes.
CTSN Chairman Dr A. Marc Gillinov said: We are excited to work with Mesoblast to make a real impact on the high mortality associated with COVID-19. Thisrandomized controlled trialis in line with our mandate torigorously evaluate novel therapies forpublic health imperatives.
Professor and System Chair of Population Health Science and Policy and the Edmond A. Guggenheim Professor of Health Policy at the Icahn School of Medicine at Mount Sinai, Dr Annetine Gelijns, said: The COVID-19 pandemic has resulted in very large numbers of people suffering with ARDS requiring ventilation in hospital intensive care units, with dismal outcomes, placing an enormous burden on the United States health system.We are committed to evaluating whether Mesoblasts mesenchymal stem cell product candidate for ARDS has the potential to make an impact on this unprecedented health crisis.
ARDS occurs due to an excessive immune response against the COVID-19 virus in the lungs, with the inflammatory cytokines produced by the immune cells (cytokine storm) destroying the lung tissue. These inflammatory cytokines also can cause damage to other organs such as liver, kidney, and heart.
Remestemcel-L is being developed for various inflammatory conditions, and is believed to counteract the inflammatory processes implicated in these diseases by down-regulating the production of pro-inflammatory cytokines, increasing production of anti-inflammatory cytokines, and enabling recruitment of naturally occurring anti-inflammatory cells to involved tissues.The safety and therapeutic effects of remestemcel-L intravenous infusions have been evaluated in over 1,100 patients in various clinical trials.
Remestemcel-L was successful in a Phase 3 trial for steroid-refractory acute graft versus host disease (aGVHD) in children, a potentially fatal inflammatory condition due to a similar cytokine storm process as is seen in COVID-19 ARDS.Additionally, a post-hoc analysis of a randomized, placebo-controlled study in 60 patients with chronic obstructive pulmonary disease demonstrated that remestemcel-L significantly improved respiratory function in patients with the same elevated inflammatory biomarkers that are also observed in patients with COVID-19 ARDS. Together, these outcomes provide the rationale for evaluating remestemcel-L in patients with COVID-19 ARDS.
Mesoblast Chief Medical Officer Dr Fred Grossman said: The mortality rate in moderate to severe ARDS due to COVID-19 can be as high as 80%. Remestemcel-L has demonstrated safety, efficacy and significant survival benefit in aGVHD where inflammation is at the core, similar to ARDS from COVID-19. The mechanism of action of remestemcel-L demonstrated in aGVHD supports the evaluation of remestemcel-L to safely tame a similar cytokine storm in the lungs that leads to the high mortality in patients with COVID-19.
About MesoblastMesoblast Limited (Nasdaq: MESO; ASX: MSB) is a world leader in developing allogeneic (off-the-shelf) cellular medicines. The Company has leveraged its proprietary mesenchymal lineage cell therapy technology platform to establish a broad portfolio of commercial products and late-stage product candidates. Mesoblasts proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide.
Story continues
Mesoblasts Biologics License Application to seek approval of its product candidate RYONCIL (remestemcel-L) for steroid-refractory acute graft versus host disease (acute GVHD) has been accepted for priority review by the United States Food and Drug Administration (FDA). Remestemcel-L is also being developed for other rare diseases. Mesoblast is completing Phase 3 trials for its product candidates for advanced heart failure and chronic low back pain. If approved, RYONCIL is expected to be launched in the United States in 2020 for pediatric steroid-refractory acute GVHD. Two products have been commercialized in Japan and Europe by Mesoblasts licensees, and the Company has established commercial partnerships in Europe and China for certain Phase 3 assets.
Mesoblast has a strong and extensive global intellectual property (IP) portfolio with protection extending through to at least 2040 in all major markets. This IP position is expected to provide the Company with substantial commercial advantages as it develops its product candidates for these conditions.
Mesoblast has locations in Australia, the United States and Singapore and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). For more information, please see http://www.mesoblast.com, LinkedIn: Mesoblast Limited and Twitter: @Mesoblast
Forward-Looking StatementsThis announcement includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements include, but are not limited to, statements about the initiation, timing, progress and results of Mesoblast and its collaborators clinical studies; Mesoblast and its collaborators ability to advance product candidates into, enroll and successfully complete, clinical studies; the timing or likelihood of regulatory filings and approvals; and the pricing and reimbursement of Mesoblasts product candidates, if approved; the potential benefits of strategic collaboration agreements and Mesoblasts ability to maintain established strategic collaborations; Mesoblasts ability to establish and maintain intellectual property on its product candidates and Mesoblasts ability to successfully defend these in cases of alleged infringement; the scope of protection Mesoblast is able to establish and maintain for intellectual property rights covering its product candidates and technology. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblasts actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise.
Release authorized by the Chief Executive.
For further information, please contact:
See the rest here:
- Stem Cell Therapy Market Is Projected To Achieve A Market Value Of USD 3.40 Bn. By 2030, Reflecting A Robus... - WhaTech - October 18th, 2024
- Doctor who provided ineffective stem cell therapies disciplined 6 years after investigation began - CBS Chicago - October 15th, 2024
- Study reveals the benefits and downside of fasting - Big Think - September 28th, 2024
- Tiny vesicles from umbilical cord blood may have therapeutic benefit - Parkinson's News Today - September 28th, 2024
- The Stem Cell Solution Review: Is This Program the Future of Anti-Aging and Recovery? - Enumclaw Courier-Herald - September 28th, 2024
- Cell and Gene Therapy Research To Benefit From New Stem Cell Collection Center - Technology Networks - September 25th, 2024
- Stem Cell Restore: A Full Review of Its Role in Promoting Regeneration and Vitality - Islands' Sounder - September 18th, 2024
- Is fasting good for you? A new study reveals some hidden risks and benefits of the practice - Business Insider India - August 31st, 2024
- Study reveals the benefits and downside of fasting - MIT News - August 27th, 2024
- Scilex Holding Company Announces the U.S. Patent and Trademark Office Will Be Issuing New ELYXYB® Patent Related to the Treatment of Acute Pain - August 22nd, 2024
- Oragenics Inc. Completes Spray Dry Drug Manufacturing and Intranasal Device Filling in Anticipation of Phase IIa Clinical Trial in Concussed Patients - August 22nd, 2024
- Orion Corporation: Managers’ transactions – Niclas Lindstedt - August 22nd, 2024
- PharmaTher’s Sairiyo Therapeutics Announces Independent Screening Identifying Cepharanthine’s Potential to Bind to Monkeypox (Mpox) Proteins - August 22nd, 2024
- BRIGHT GREEN EMBARKS ON MAJOR PARTNERSHIP WITH BENUVIA PHARMACEUTICALS. WILL SUPPLY PHARMA EXPERT WITH AMERICAN MADE RAW MATERIALS FROM ITS INDUSTRY... - August 22nd, 2024
- Eyenovia Announces Pricing of $5.14 Million Public Offering - August 22nd, 2024
- Firefly Neuroscience Forms Strategic Partnership with Neurology Consultants of Dallas (NCD) to Enhance Early Detection Efforts and Disease Management... - August 22nd, 2024
- Clearmind Medicine Granted U.S. Patent Approval for Binge Behavior Treatment - August 22nd, 2024
- SIGA Announces New Contract Awarded by U.S. Department of Defense for the Procurement of $9 Million of TPOXX® - August 22nd, 2024
- MDxHealth Reports Q2 and Half Year 2024 Results - August 22nd, 2024
- Bavarian Nordic Receives 440,000 Dose Contract to Supply Smallpox and Mpox Vaccines for Undisclosed European Country - August 22nd, 2024
- Brains Bioceutical Set to Achieve One of the World’s First CEP for Cannabidiol Certification with the European Directorate for the Quality of... - August 22nd, 2024
- Cytek® Biosciences Achieves ISO 13485 Certification at San Diego Reagent Manufacturing Facility - August 22nd, 2024
- Certara to Participate in Upcoming Investor Conferences - August 22nd, 2024
- Orion Corporation: Managers’ transactions – Satu Ahomäki - August 22nd, 2024
- Bavarian Nordic Announces First Half 2024 Results - August 22nd, 2024
- BioCryst to Present at Upcoming Investor Conferences - August 22nd, 2024
- Zymeworks Announces Participation in Upcoming Investor Conferences - August 22nd, 2024
- MediWound Reports Second Quarter 2024 Financial Results and Provides Company Update - August 14th, 2024
- Viracta Therapeutics Announces Positive Data from the Phase 2 NAVAL-1 Trial, Regulatory Progress, and Updated Nana-val Clinical Development Plan - August 14th, 2024
- Shock Top and Gator Athletics Partner to Introduce First-Ever Craft Beer Sponsorship of the Florida Athletic Department - August 14th, 2024
- IGM Biosciences Announces Second Quarter 2024 Financial Results and Provides Corporate Update - August 14th, 2024
- Achilles Therapeutics Reports Second Quarter 2024 Financial Results and Recent Business Updates - August 14th, 2024
- Neumora Therapeutics to Host Key Opinion Leader Roundtable to Discuss the Potential of Navacaprant in Neuropsychiatric Disorders - August 14th, 2024
- Evaxion Announces Business Update and Second Quarter 2024 Financial Results - August 14th, 2024
- Galera Announces Board Approval of Complete Liquidation and Dissolution - August 14th, 2024
- Outlook Therapeutics® Reports Financial Results for Third Quarter Fiscal Year 2024 and Provides Corporate Update - August 14th, 2024
- Viracta Therapeutics Reports Second Quarter 2024 Financial Results and Provides Business Update - August 14th, 2024
- Omega Therapeutics Announces Jennifer Nelson, Ph.D., as Senior Vice President of Research - August 14th, 2024
- CorMedix Inc. Reports Second Quarter and Six Month 2024 Financial Results and Provides Business Update - August 14th, 2024
- Panavance Therapeutics Announces Foundational Publication of Misetionamide (GP-2250) in Ovarian Cancer in the Journal, Cancer Medicine - August 14th, 2024
- Abeona Therapeutics® Announces Appointment of Bernhardt Zeiher, MD, FCCP, FACP, and Eric Crombez, MD to its Board of Directors - August 14th, 2024
- Veralox Therapeutics Announces EMA Orphan Drug Designation for VLX-1005 - August 14th, 2024
- Verrica Pharmaceuticals Announces Positive Preliminary Topline Results from Part 2 of Phase 2 Clinical Study of VP-315, an Investigational Oncolytic... - August 14th, 2024
- Verrica Pharmaceuticals Reports Second Quarter 2024 Financial Results - August 14th, 2024
- Novo Nordisk A/S: Trading in Novo Nordisk shares by board members, executives and associated persons - August 14th, 2024
- Atsena Therapeutics Receives Rare Pediatric Disease Designation from the U.S. FDA for ATSN-201 Gene Therapy to Treat X-linked Retinoschisis - August 14th, 2024
- Aquestive Therapeutics Comments on Recent FDA Approval of Non-Injection-Based Epinephrine Product for the Treatment of Anaphylaxis and Reiterates... - August 14th, 2024
- What Is Stem Cell Therapy? How Does It Work? - ThePrint - August 6th, 2024
- New Study Shows Short-Term Benefits of Stem Cell Therapy for MS Patients, But Long-Term Efficacy Remains Unclear - Managed Healthcare Executive - July 26th, 2024
- Cord Blood Awareness Month: Advantages of cord blood banking, things to keep in mind - Moneycontrol - July 10th, 2024
- Neural Stem Cell Plasticity: Advantages in Therapy for the Injured Central Nervous System - Frontiers - June 28th, 2024
- Harnessing benefits of stem cells for heart regeneration | ASU News - ASU News Now - June 21st, 2024
- 'Didn't know this would be possible': Autistic teen's mom on stem cell therapy benefits - WZTV - May 6th, 2024
- John Cleese says he's been spending 17,000 annually on stem cell therapy to 'buy a few extra years' - Yahoo News UK - April 24th, 2024
- Promethera Bets Liver-Derived Stem Cells Will Offer Benefits In NASH - Scrip - April 24th, 2024
- Stem Cell Therapies: Is This The Future Of Wellness? - Grazia USA - April 20th, 2024
- Signal of Benefit for Stem Cell Therapy in Progressive MS - Medscape - March 7th, 2024
- The Controversies Surrounding Stem Cell Therapy for Autism - The Portugal News - February 24th, 2024
- Benefits of Stem Cell Therapy - News Channel 5 Nashville - February 7th, 2024
- What is Stem Cell Therapy & How It Helps Others - Publicist Paper - January 31st, 2024
- A guide to stem cell therapy in Thailand - Thaiger - January 4th, 2024
- Half of pediatric patients with aHUS benefit from Soliris after... - AHUS News - December 21st, 2023
- Real world analysis on the determinants of survival in primary ... - Nature.com - December 5th, 2023
- The Best Beauty Gifts According To People Who Really Know Skin Care - HuffPost - December 5th, 2023
- The Eyepopping Factory Construction Boom in the US - WOLF STREET - December 3rd, 2023
- Benefit of Neoadjuvant Therapy Illustrated During ESMO Congress ... - Targeted Oncology - December 1st, 2023
- Benefits Outweigh Risks as FDA Inspects CAR-T Cell Therapy ... - Curetoday.com - December 1st, 2023
- Review What Real Cavityn Customers Say About Benefits and Side ... - Seattle Weekly - December 1st, 2023
- 'There is a Scientific Fraud Epidemic' - Slashdot - Slashdot - December 1st, 2023
- 15 Best Hydrating Serums to Soothe Any Skin Type 2023 - Town & Country - December 1st, 2023
- Innovations in Cosmetic Dermatology: A Glimpse into the Future - APN News - December 1st, 2023
- FDA Probes New Cases of Cancer That May Stem From Cancer Cell ... - MedCity News - November 29th, 2023
- Use of plant stem cells in topical formulations on the rise - CosmeticsDesign.com USA - November 29th, 2023
- Stem cell-based treatment controls blood sugar in people with Type ... - EurekAlert - November 29th, 2023
- Biologics Market is projected to grow at a CAGR of 8.5% by 2034: Visiongain - Yahoo Finance - November 29th, 2023
- Scientists devise new technique that can pinpoint the causes and ... - EurekAlert - November 29th, 2023
- Global Advanced Therapy Medicinal Products Market is on the brink ... - PharmiWeb.com - November 29th, 2023
- Introducing Orgavalue - The 2023 EIT InnoStars Awards winner - EU-Startups - November 29th, 2023
- Episode 160: Euan Ashley discusses precision medicine and the ... - IHMC - November 29th, 2023
- Is Phenq Right For You? Review The Facts Before Making a ... - Vashon-Maury Island Beachcomber - November 27th, 2023
Recent Comments