Other Neurological Indications

In addition to ischemic stroke, Athersys has established collaborative relationships with independent investigators that are evaluating the potential application for MultiStem to treat a range of other neurological indications, including traumatic brain injury (TBI), neonatal hypoxic ischemia, spinal cord injury, multiple sclerosis (MS), and Parkinson’s disease. Each of these represent significant areas of unmet medical need, where conventional approaches have had limited impact, and also represent substantial market opportunities.

Based on the research conducted by us and our collaborators, we believe MultiStem conveys significant benefits when administered to treat various types of neurological injury and disease.  Published research has shown that MultiStem can work through several distinct mechanisms, including reducing inflammatory damage, protecting at risk tissue at the site of injury, and through direct neurotrophic effects that stimulate the recovery of damaged neurons. As a result, we believe that MultiStem may have relevance for treating many forms of neurological injury and disease.

We are actively exploring the application of MultiStem for other neurological indications that represent areas of significant unmet medical need, such as TBI, which represents the leading cause of disability among children and young adults and a leading cause of death. Approximately 1.7 million cases of TBI are seen in the United States each year, nearly half a million cases of which are children age 0 to 14 years old. The United States Center for Disease Control and Prevention (CDC) estimates that more than 5.3 million individuals are living with a disability and have a long-term or lifelong need for help to perform activities of daily living as a result of a TBI. The annual direct and indirect costs for TBI are approximately $60 billion a year, according to the National Institute of Neurological Disorders and Stroke, which is part of the National Institutes of Health. In preclinical studies of TBI, administration of MultiStem dramatically reduced the extent of damage caused by a TBI and promoted accelerated healing of the blood-brain barrier. In 2012, we announced grant funding aggregating $3.6 million to further advance our MultiStem programs and cell therapy platform, including further development of MultiStem for the treatment of TBI and our cell therapy formulations and manufacturing capabilities.

In 2010, we announced that we and collaborators at the Center for Stem Cell and Regenerative Medicine and Case Western Reserve University were awarded $1.0 million through the Ohio Third Frontier Biomedical Program to support preclinical and translational research into the treatment of spinal cord injury (SCI) with MultiStem. In 2012, we presented data at the Annual Society for Neuroscience meeting that demonstrated that intravenous administration of MultiStem one day after SCI results in statistically significant and sustained improvements in gross locomotor function, fine locomotor function and bladder control compared to control treated animals.

In 2011, we announced the award of grant funding of up to $640,000 to investigate the potential for MultiStem to treat chronic progressive multiple sclerosis (MS) based on initial results in preclinical models. In 2012, in collaboration with scientists from Case Western Reserve University, and with the support of Fast Forward and the National Multiple Sclerosis Society, we reported research results that demonstrate the potential benefits of MultiStem therapy for treating MS. In standard preclinical models of MS, researchers observed that MultiStem administration results in sustained behavioral improvements, arrests the demyelination process that is central to the pathology of MS and supports remyelination of affected axons.

We continue to advance these and other programs involving acute or chronic neurological injury and disease.