Separate grants will allow firm to develop a TBI treatment and improve manufacturing.

Athersys reports that it has received $3.6 million to advance its MultiStem® products and cell therapy platform. The company was awarded an 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, obtained $1.2 million (€0.9 million) from Belgium’s Agency for Innovation by Science and Technology (IWT) to develop cell therapy formulations and manufacturing capabilities. The company says that it 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,” comments Gil Van Bokkelen, Ph.D., Athersys chairman and 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.”

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 program will include preclinical safety and efficacy studies required to support an IND application and the clinical investigation of MultiStem treatment of TBI.

“Our prior work with Athersys has demonstrated that MultiStem modulates the inflammatory component of secondary brain injury in preclinical models of TBI,” explains Charles Cox Jr., M.D., who directs the effort at UTHealth Medical School that is focused on stem cell therapy for neurological injuries and who will lead the collaboration with Athersys.

The IWT grant will fund a product and process development program. A principal focus will be the continued development of serum-free formulations for the manufacture of MultiStem and related cell therapy products.  ReGenesys will collaborate with researchers from the Katholieke Universiteit of Leuven as well as certain corporate partners.

“Our ReGenesys affiliate plays a significant role in the development of improved process and manufacturing approaches for cell therapy products,” points out 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-based cell therapies have 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, according to Athersys.

Athersys has forged strategic partnerships with Pfizer to develop MultiStem for inflammatory bowel disease and with RTI Biologics to develop cell therapy for use with a bone allograft product in the orthopedic market.

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