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Athersys, Inc. (NASDAQ: ATHX), a leader in the emerging field of regenerative medicine, announced today grant funding aggregating $3.6 million to further advance its MultiStem® product programs and cell therapy platform. Specifically, Athersys was awarded a SBIR Fast-Track grant of up to $1.9 million from the National Institute of Neurological Disorders and Stroke (NINDS) to develop MultiStem for the treatment of traumatic brain injury (TBI). In addition, Athersys’ subsidiary based in Belgium, ReGenesys BVBA, was awarded a $1.2 million (€0.9 million) grant from the Belgium’s Agency for Innovation by Science and Technology (IWT) to further develop cell therapy formulations and manufacturing capabilities. The company has also been awarded funding recently to work in other areas, such as using MultiStem to treat chronic cardiovascular disease.
“These grant awards provide us with additional funding to support further development of MultiStem in specific therapeutic areas, as well as enhance our manufacturing platform,” said Dr. Gil Van Bokkelen, Athersys Chairman & CEO. “Historically, we have been very successful at obtaining this type of funding, which reflects our commitment to outstanding science and technology development, and development of innovative new therapies.”
NINDS TBI Grant
The work under the NINDS grant to develop MultiStem for the treatment of TBI will be conducted in collaboration with researchers at The University of Texas Health Science Center at Houston (UTHealth) Medical School. The research program will include preclinical safety and efficacy studies required to support an Investigational New Drug (IND) application and the clinical investigation of MultiStem treatment of TBI.
TBI is a serious clinical problem that affects young people, members of the armed services and other adults. According to the Centers for Disease Control, there are nearly 1.4 million emergency room visits each year as a result of TBI, resulting in 275,000 hospitalizations and 52,000 deaths annually.
“Based on the results from studies conducted with our collaborators, we believe MultiStem could have a significant impact in treating damage from acute neurological injury, such as TBI, ischemic stroke and other indications,” said Dr. Van Bokkelen.
Dr. Charles Cox, Jr., who directs the multi-disciplinary effort at UTHealth Medical School that is focused on stem cell therapy for traumatic brain injury and related neurological injuries, will lead the collaboration with Athersys. “Our prior work with Athersys has demonstrated that MultiStem modulates the inflammatory component of secondary brain injury in preclinical models of TBI," said Dr. Cox, professor of pediatric surgery at UTHealth and director of the pediatric trauma program at Children’s Memorial Hermann Hospital in Houston. “This is an area of tremendous unmet medical need, which carries both a high cost burden, as well as impacting patient and family quality of life. We will build on this promising work to advance the application of this cell therapy into clinical studies.”
IWT Grant
The IWT grant will fund a product and process development program undertaken in Belgium by ReGenesys, Athersys’ affiliate. A principal focus of these efforts will be the continued development of serum-free formulations for the manufacture of MultiStem and related cell therapy products. ReGenesys researchers will collaborate with researchers from the Katholieke Universiteit of Leuven, as well as certain corporate partners to complete the program.
“Our ReGenesys affiliate plays a significant role in the development of improved process and manufacturing approaches for cell therapy products,” said William Lehmann, President and COO of Athersys, and Manager of ReGenesys. “We expect this grant-funded work to have substantial impact on product manufacturing and clinical development in Europe and globally.”
MultiStem® cell therapy is a patented product that has shown the ability to promote tissue repair and healing in a variety of ways, such as through the production of multiple therapeutic factors produced in response to signals of inflammation and tissue damage. MultiStem has demonstrated therapeutic potential for the treatment of inflammatory and immune disorders, neurological conditions, and cardiovascular disease, as well as other areas, and represents a unique "off-the-shelf" stem cell product that can be manufactured in a scalable manner and stored for years in frozen form. The product is extensively characterized for safety, consistency and potency. Athersys has forged strategic partnerships with Pfizer Inc. to develop MultiStem for inflammatory bowel disease and with RTI Biologics, Inc. to develop cell therapy for use with a bone allograft product in the orthopedic market.
Athersys is a clinical stage biopharmaceutical company engaged in the discovery and development of therapeutic product candidates designed to extend and enhance the quality of human life. The Company is developing its MultiStem® cell therapy product, a patented, adult-derived "off-the-shelf" stem cell product platform for disease indications in the cardiovascular, neurological, inflammatory and immune disease areas. The Company currently has several clinical stage programs involving MultiStem, including for treating inflammatory bowel disease, ischemic stroke, damage caused by myocardial infarction, and for the prevention of graft versus host disease. Athersys has also developed a diverse portfolio that includes other technologies and product development opportunities, and has forged strategic partnerships and collaborations with leading pharmaceutical and biotechnology companies, as well as world-renowned research institutions in the United States and Europe to further develop its platform and products.
Source: Athersys
Tags: financing
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