Athersys (ATHX) Announces Favorable Preclinical Results for MultiStem Treatment in Defense Department Radiation Countermeasure Study

Athersys, Inc. (Nasdaq: ATHX) announces today results of a radiation countermeasure study conducted by the Armed Forces Radiobiology Research Institute (AFRRI), a Department of Defense research laboratory under the leadership of the Uniformed Services University of the Health Sciences, that showed intravenous MultiStem® (invimestrocel) administration provided benefit in an animal model of acute radiation syndrome (ARS). The results demonstrate that the administration of MultiStem cells increased survival in treated animals compared to vehicle treatment (p=0.03), resulted in higher body weights in surviving animals and positive trends in recovery of the hematopoietic system.

“This program represents another positive step in a broader development strategy to investigate the use of MultiStem in addressing severe critical care injuries and diseases,” commented Mr. Dan Camardo, Chief Executive Officer of Athersys.

Athersys has conducted research relevant to ARS over several years. Its initial research focused on hematopoietic stem cell transplant (HSCT) and graft versus host disease (GvHD) areas, including a clinical study demonstrating that MultiStem treatment has the potential to improve survival and neutrophil and platelet recovery and reduce GvHD in HSCT patients. Athersys also completed pilot work on ARS undertaken in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID) and the Armed Forces Radiobiology Research Institute (AFRRI).

In general, this research has demonstrated the potential for MultiStem treatment to improve survival and recovery following radiation injury. The recent countermeasure study builds on this foundation. In summary, 25 mice received two doses of MultiStem cells and 25 received two doses of vehicle, administered intravenously. Survival was evaluated at day 30 from irradiation, with 84% survival of MultiStem-treated rodents compared to 52% survival of vehicle-treated animals (p=0.03). Additionally, body weight was significantly different between the groups (p<0.01) – higher in the MultiStem group – reflecting reduced weight loss associated with the acute injury and/or accelerated recovery. Further, there were trends towards increased megakaryocytes and bone marrow colony forming units in surviving animals at day 60.

“We are very enthusiastic about the results from this radiation countermeasure study conducted by AFRRI,” commented Dr. Robert W. Mays, Executive Vice President and Head of Regenerative Medicine & Neuroscience Programs of Athersys. “Based on this study and prior research, we believe that MultiStem therapy has the potential to provide benefit to victims of ARS as well as other immune and neurological disorders. We look forward to exploring opportunities to move this important program forward.”

This study is one of several preclinical programs that will be the focus of an upcoming webinar hosted by the Regenerative Medicine team at Athersys titled, Rebalancing the Immune System: The MultiStem® Cellular Platform for Treating Disease and Injury. Preclinical research using MultiStem cells has shown Multipotent Adult Progenitor Cells, or MAPC®, may be beneficial in the treatment of a variety of critical care and difficult to treat inflammatory diseases. On Monday, August 29, 2022, Dr. Robert W. Mays and Dr. Sarah Busch, Vice President, Regenerative Medicine & Head of Nonclinical Development, will be hosting a webinar to provide a comprehensive update on the Company’s preclinical programs.

About Acute Radiation Syndrome

Acute Radiation Syndrome, or ARS, is an acute condition resulting from irradiation of the body by a high dose of penetrating radiation over a short period of time. ARS may be associated with destructive and irreparable changes in the bone marrow and gastrointestinal (GI) tract, resulting in infection, hemorrhage and dehydration. The condition may also lead to edema, vasculitis and failure of the cardiovascular and central nervous systems. Examples of ARS victims include survivors of the Hiroshima and Nagasaki atomic bombs and the first responders to the 1986 Chernobyl nuclear power plant event. The Syndrome develops in stages as a function of the dose received. At lower doses a period of bone marrow damage lasting weeks which ultimately can be lethal without intervention is expected. At higher doses of radiation, the GI tract would be impacted immediately to shortly after exposure, followed by a period of bone marrow damage lasting weeks, then a period of severe symptoms and illness including further GI involvement, infection and hemorrhage, and then recovery or death depending on the exposure levels and bone marrow recovery.

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