MultiStem, a cell therapy in development at Athersys, was recently designated “Highly Relevant” as a Potential Therapy for COVID-19 by BARDA. The study’s large enrollment size could mean that it could take a couple of years to get to the results. The inherently unpredictable nature of the ebb and flow of the number of COVID-19 infections, as well as the concurrently shifting availability of other treatments and testing of other candidates, make it difficult to assess how motivated patients and their families will be to enroll in the phase II/III trial.Known as MACOVIA, the primary efficacy endpoint is the number of ventilator-free days through day 28 vs. placebo. While many individuals will recover from viral infection after therapy. A summary video from the Investor Day event will be available on the Company’s website approximately one week after the event.“We are honored to have received Fast Track designation from the FDA for our ARDS program, which supports the promise of our cell therapy for treating patients in an area where new and more effective treatments are needed.
Chairman and CEO Gil Van Bokkelen, PhD, Discusses BARDA’s “Highly Relevant” Designation for MultiStem with GENAthersys founder, chairman, and CEO Gil Van Bokkelen, PhDOne of those companies was Athersys, the developer of a proprietary stem cell product called MultiStem®. phase (Phase 2a portion). Dr. Bellingan’s talk is titled, “Fast Track is a process designed by the FDA to facilitate the development and expedite the review of drugs that have the potential to treat serious conditions and address recognized areas of unmet medical need. Developed from Multipotent Adult Progenitor Cells (MAPC®) obtained from the bone marrow of healthy, consenting adult donors. If you experience any issues with this process, please contact us for further assistance.Dr. or critical illness as well as death in some patients.
Secondary endpoints include 60-day all-cause mortality, time in the intensive care unit, pulmonary function, tolerability and quality of life among survivors after one year.Other recent small clinical trials provide some reason to hope for some success with stem cells in COVID-19 treatment.
“That compares to only 40% of the patients that were being treated under best available standard of care.”“Perhaps just as importantly, among those patients that were treated with MultiStem, they were typically in the 90 to 95% range in terms of their own quality of life assessment on a zero-to-100 point scale—whereas the patients that were treated under best available standard of care, were typically in the 40 to 50% range,” he added. This would include SARS-COV-2, as well as any secondary bacterial pneumonia infection in the same patient.Multistem is thought to express factors that work to reduce inflammation, protect damaged or injured tissue and enhance the formation of new blood vessels after injury.
Athersys says it is working as fast as it can to launch a pivotal trial of its in acute respiratory distress syndrome (ARDS), after the clinical program received the “Highly Relevant” designation for COVID-19 from the Biomedical Advanced Research and Development Authority (BARDA). “Sometimes, when people hear stem cells, they think about stem cells going in and repopulating and growing into new cells that would then replace the old cells in the patient.
There are limited interventions and no effective drug treatments for ARDS, making it an area of high unmet clinical need with high treatment costs. Athersys Candidate: MultiStem® for acute respiratory distress syndrome (ARDS) Type: Adult-derived “off-the-shelf” therapy under development for several neurological and cardiovascular diseases, as well as inflammatory, immune and related disorders.
Many patients that do survive face extended stays in the ICU and experience difficult and challenging recoveries.
This designation complements other indications where we have received important regulatory designations, including Fast Track and RMAT designations for our ongoing Phase 3 program for ischemic stroke,” commented Dr. Gil Van Bokkelen, Chairman and CEO, at Athersys.
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The cells can be prepared for the patient in less than one hour.For MultiStem’s most advanced indication of ischemic stroke, Athersys is enrolling patients in the Phase III MASTERS-2 trial in the U.S. (NCT03545607) while collaboration partner HEALIOS is doing likewise for the confirmatory TREASURE study (NCT02961504) in Japan.Other indications include four neurological conditions: hemorrhagic stroke, traumatic brain injury, multiple sclerosis, spinal cord injury; acute myocardial infarction; the cardiovascularconditions peripheral vascular disease, also called peripheral arterial disease, which can develop into critical limb ischemia; prevention of Graft-Versus-Host Disease in patients undergoing allogeneic hematopoietic stem cell transplant; trauma, and solid organ transplant support.By the time COVID-19 emerged, Athersys was familiar to BARDA, having previously worked on areas the company has not made public, but which Van Bokkelen said were directly relevant to BARDA’s mission of helping secure the U.S. from chemical, biological, radiological, and nuclear (CBRN) threats, as well as from pandemic influenza and emerging infectious diseases: “They already knew who we were, and frankly they already had a good sense of what our technology is capable of.
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