Athersys has received U.S. Food and Drug Administration (FDA) authorization to initiate a clinical trial in patients that have suffered an ischemic stroke, a leading cause of death and disability in the U.S. and the rest of the world;  Recently published preclinical data now available online in the Journal of Experimental Stroke & Translational Medicine reports demonstrated benefit from MultiStem delivery several days following a stroke. The phase I study authorized by the FDA allows for administration of MultiStem to stroke patients 48 to 60 hours after a stroke has occurred, in contrast to the current standard of care which must be administered within 3 to 4 hours, a limitation that prevents most stroke victims from receiving treatment; During this panel, new preclinical data were presented demonstrating that administration of MultiStem resulted in a significant reduction of both inflammation and death of neurons in the brain following a stroke; New data and preclinical research were also presented that showed that administration of MultiStem preserves blood-brain barrier integrity following traumatic brain injury and results in expression of key anti-inflammatory cytokines; Additional new preclinical research was presented in spinal cord injury, including new data demonstrating that MultiStem administration can help block the neuronal retraction or "dieback" process that occurs in spinal cord injury, as well as demonstrating that MultiStem cells home to the site of an injury and can actually reverse the "dieback" process by expressing factors that promote neuronal sprouting; This panel included the following neurological disease experts: Dr. David Hess, Chairman of Neurology at Medical College of Georgia Dr. Charles Cox, Director of Pediatric Trauma at the University of Texas Houston Medical Center Dr. Jerry Silver, Professor of Neuroscience at Case Western Reserve University and adjunct Professor of Neurosurgery at the Cleveland Clinic

"I began working with MultiStem several years ago because I was excited by the possibility of an off-the-shelf, non-immunogenic, intravenous stem cell therapy that could potentially ameliorate the effects of spinal cord injury," stated Dr. Silver. "My research experience with these cells is that they are, indeed, fascinating. I have seen remarkable effects with MultiStem in preventing axonal dieback and promoting axonal sprouting -- the most impressive impact of any potential therapy in my 30 years of research. More studies are needed to determine the full functional benefits, but the results we've seen so far are extremely promising."

Immune System Disorders

Presentations highlighted ways in which MultiStem can reduce inflammation and regulate immune system function, as well as modulate key pathways relevant to acute injury and autoimmune disease. Investigators also provided detailed new insights as to how MultiStem differs from other cell therapies being explored clinically, such as through its ability to reduce inflammatory cell migration, regulate expression of key biological pathways in other cell types, and promote tissue repair; Athersys and collaborators highlighted preclinical research and the ongoing phase I clinical trial of MultiStem administered to leukemia or lymphoma patients, as well as a summary of how MultiStem is being developed as a treatment for inflammatory bowel disease in collaboration with Pfizer;  This panel included the following immune system disorder experts: Dr. Richard Maziarz, Medical Director “ Bone Marrow Transplantation & Professor of Regenerative Medicine at Oregon Health Sciences University Dr. Ruth McKernan, Head of Pfizer Regenerative Medicine Dr. Robert Deans, Senior Vice President of Regenerative Medicine at Athersys

"As described by the team of investigators presenting here today, we are learning more about the biology of these cells and their therapeutic potential," said Dr. McKernan. "The Pfizer and Athersys teams are working well together and we look forward to evaluating the potential of MultiStem in our clinical studies."

Pharmaceutical Programs

Athersys also presented data describing development of highly potent and selective compounds for the treatment of obesity that act by stimulating the 5HT2c receptor in the brain, which regulates appetite and food intake; The Company presented new research showing Athersys has successfully developed a new class of 5HT2c agonists that are very potent at the 5HT2c receptor, but lack activity at the 5HT2b and 5HT2a receptors -- this selectivity is key to minimizing unwanted drug effects and toxicity; This panel included the following experts: Dr. Xavier Pi-Sunyer, Professor of Medicine at Columbia University College of Physicians and Surgeons, Chief of Endocrinology, Diabetes and Nutrition at St. Luke's-Roosevelt Hospital Center, and Director of the New York Obesity Research Center Dr. John Harrington, Chief Scientific Officer and Executive Vice President at Athersys SOURCE Athersys, Inc.