Athersys Announces Completion of Patient Enrollment in Phase I Study of Multistem(R) in Acute Myocardial Infarction
- Category: DNA RNA and Cells
- Published on Tuesday, 16 February 2010 21:19
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Athersys has completed patient enrollment for its phase I clinical trial of MultiStem®, its allogeneic stem cell therapy product, administered to individuals following acute myocardial infarction (AMI)
CLEVELAND, OH, USA I February 16, 2010 I Athersys, Inc. (Nasdaq:ATHX - News) today announced that it has completed patient enrollment for its phase I clinical trial of MultiStem®, its allogeneic stem cell therapy product, administered to individuals following acute myocardial infarction (AMI), more commonly referred to as a heart attack. Top line results of the trial are expected to be announced midyear, upon completion of the four-month patient follow-up visits and analysis of results.
"Myocardial infarction remains one of the leading causes of death and disability in the United States," commented William (B.J.) Lehmann, President and COO of Athersys, who is presenting today at the 5th Annual Stem Cell Summit in New York City. "Based on our preclinical work and data, we believe that MultiStem has the potential to improve heart function in patients following heart attacks in multiple ways. The completion of this phase I safety study represents an important step in the development of MultiStem for this condition, and we look forward to evaluating the data from the trial upon completion of the follow-up visits."
The phase I clinical trial is an open label, multi-center dose escalation trial evaluating the safety and maximum tolerated dose of a single administration of allogeneic MultiStem cells following an AMI. Following standard treatment, enrolled patients receive MultiStem delivered via a catheter that enables rapid and efficient delivery of MultiStem into the damaged region of the heart. The study is being conducted at multiple cardiovascular treatment centers in the United States, including the Cleveland Clinic, Columbia University Medical Center and Henry Ford Health System, and includes patients in three treatment cohorts or dose groups, as well as a non-treated registry group.
In preclinical studies conducted by the Company and independent cardiovascular research teams, administration of MultiStem following an ischemic injury to the heart has been associated with a number of benefits, including an increase in ejection fraction, or volume of blood pumped from the heart, a reduction of inflammation in the region of ischemic injury and increased angiogenesis, each believed to help augment recovery and healing.
Athersys is jointly developing MultiStem for AMI with Angiotech Pharmaceuticals, Inc. Angiotech is a global specialty pharmaceutical company that discovers, develops and markets innovative treatment solutions for diseases or complications associated with medical device implants, surgical interventions and acute injury. To find out more about Angiotech (Nasdaq:ANPI - News) (TSX:ANP - News), please visit their website at www.angiotech.com.
MultiStem is a patented and proprietary cell therapy product consisting of a special class of stem cells that are obtained from the bone marrow or other tissue sources of healthy, consenting adult donors, and which have the demonstrated ability to produce a range of factors, as well as form multiple cell types. MultiStem appears to promote tissue repair and healing in multiple ways, such as through the production of multiple therapeutic factors produced in response to signals of inflammation and tissue damage. Athersys believes that MultiStem represents a unique "off-the-shelf" stem cell product based on work that demonstrates the ability to deliver multiple mechanisms of therapeutic benefit, administration of the product without tissue matching or immunosuppression, and its capacity for large-scale production. Athersys has forged strategic partnerships with Pfizer to develop MultiStem for inflammatory bowel disease (IBD) and with Angiotech to develop MultiStem in AMI and other cardiovascular indications. In 2008, Athersys received the Frost & Sullivan North American Product Innovation of the Year Award for MultiStem, which cited the product as having best-in-class potential among stem cell and regenerative medicine technologies.
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 MultiStem®, a patented, adult-derived "off-the-shelf" stem cell product platform for multiple disease indications, including damage caused by myocardial infarction, bone marrow transplantation and oncology treatment support, ischemic stroke, and inflammatory bowel disease. The Company is also developing a portfolio of other therapeutic programs, including orally active pharmaceutical product candidates for the treatment of metabolic and central nervous system disorders, utilizing proprietary technologies, including Random Activation of Gene Expression (RAGE®). Athersys has forged several key strategic alliances 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.