CLEVELAND, Sept. 23, 2010 (GLOBE NEWSWIRE) -- Athersys, Inc. ATHX announced at its presentation at the Transvascular Cardiovascular Therapeutics (TCT) Conference held in Washington, D.C., updated results from its phase I clinical trial of MultiStem®, its allogeneic cell therapy product, administered to individuals following acute myocardial infarction (AMI). Dr. Marc Penn, M.D., Ph.D., co-principal investigator of this study and Director of Cardiovascular Cell Therapy at the Cleveland Clinic, and Director of the Skirball Laboratory for Cardiovascular Cellular Therapeutics presented the results at the Symposium "Strategies for Cardiovascular Repair: Stem Cell Therapy and Beyond." The study results, based on four months of post-treatment patient data, demonstrate that MultiStem was well tolerated at all dose levels and also suggest improvement in heart function in treated patients.
New data presented by Dr. Penn included additional information about the nature and incidence of adverse events (AEs) over the first four months of the trial, demonstrating that the AEs were generally mild-to-moderate in nature, there was no dose dependent effect of MultiStem on AEs, and overall, MultiStem had a favorable safety profile. Further, Dr. Penn shared the results from additional analysis of echocardiogram data collected over the first four months of the study, which suggests that MultiStem administration may also provide improvements in other measures of heart function. Patients receiving MultiStem, for instance, demonstrated a meaningful improvement in mean wall motion score at four months compared to baseline, though this improvement was not statistically significant. Interestingly, among those patients with more severe heart attacks (i.e. left ventricular ejection fraction (LVEF), a measure of heart function, less than or equal to 45), the mean wall motion score for treated patients improved over the four-month period, while for registry patients it worsened over this time.
"We are continuing to see strong findings from this phase I study that suggest that MultiStem is well tolerated and that administration following a heart attack could provide a meaningful improvement in functional heart measures," said Dr. Penn. "These data are the first from a human trial that match the magnitude of effect seen in the preclinical studies, and support further evaluation of MultiStem as a safe and effective treatment following heart attack."
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. Enrolled patients received MultiStem delivered via a catheter into the damaged region of the heart 2-5 days following percutaneous coronary intervention, a standard treatment for heart attack. The study includes patients in three treatment cohorts or dose groups (20 million, 50 million and 100 million cells per patient) and a registry group where patients received only standard of care. Nineteen treated and six registry subjects participated in the study. The trial is being conducted at cardiovascular treatment centers in the United States, including the Cleveland Clinic, Columbia University Medical Center, Henry Ford Health System, MetroHealth System, Cardiology PC, The Care Group, and Hamot Medical Center.
In his presentation, Dr. Penn also highlighted initial findings from the phase I clinical trial, which were announced by Athersys in July. Based on four months of post-treatment patient data, the findings showed that administration of MultiStem was well tolerated at all dose levels and there were no clinically significant changes in vital signs, allergic reactions or infusion-related toxicities. Each of the trial's three dose groups demonstrated improvement in mean LVEF when compared to baseline. Further, patients in the MultiStem 50 million cell dose group showed a statistically significant improvement in mean four-month LVEF relative to baseline with a 23.4% improvement (p<0.02). Additionally, in those patients with more severe heart attacks and LVEFs less than or equal to only 45%, the MultiStem 50 and 100 million cell dose groups each demonstrated a greater than 25% improvement in mean LVEF when compared to baseline.
"We believe the data from this phase I study are exciting, and continue to shed light and provide validation for MultiStem as a stem cell therapy with broad clinical potential," said William (B.J.) Lehmann, President & COO at Athersys. "We look forward to working with our partner, Angiotech Pharmaceuticals, to advance this clinical program into phase II trials to further evaluate MultiStem's ability to improve cardiac function."
Athersys and Angiotech continue to evaluate the phase I results with study investigators and have begun planning for a subsequent clinical study, which they currently anticipate will be initiated in 2011. Further guidance about subsequent clinical development, such as trial design and timing, will be provided after evaluation and planning are completed and discussion with the FDA has occurred.
About Angiotech
Angiotech Pharmaceuticals 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 ANPI ANP, please visit its website at www.angiotech.com.
About MultiStem
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.
About Athersys
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. More information is available at www.athersys.com.
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Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. These forward-looking statements relate to, among other things, the expected timetable for development of our product candidates, our growth strategy, and our future financial performance, including our operations, economic performance, financial condition, prospects, and other future events. We have attempted to identify forward-looking statements by using such words as "anticipates," "believes," "can," "continue," "could," "estimates," "expects," "intends," "may," "plans," "potential," "should," "will," or other similar expressions. These forward-looking statements are only predictions and are largely based on our current expectations. A number of known and unknown risks, uncertainties, and other factors could affect the accuracy of these statements. Some of the more significant known risks that we face that could cause actual results to differ materially from those implied by forward-looking statements are the risks and uncertainties inherent in the process of discovering, developing, and commercializing products that are safe and effective for use as human therapeutics, such as the uncertainty regarding market acceptance of our product candidates and our ability to generate revenues, including MultiStem for the treatment of inflammatory bowel disease, acute myocardial infarction and other disease indications, and the prevention of GvHD. These risks may cause our actual results, levels of activity, performance, or achievements to differ materially from any future results, levels of activity, performance, or achievements expressed or implied by these forward-looking statements. Other important factors to consider in evaluating our forward-looking statements include: the possibility of delays in, adverse results of, and excessive costs of the development process; our ability to successfully initiate and complete a phase II clinical trial of MultiStem for AMI; changes in external market factors; changes in our industry's overall performance; changes in our business strategy; our ability to protect our intellectual property portfolio; our possible inability to realize commercially valuable discoveries in our collaborations with pharmaceutical and other biotechnology companies; our ability to meet milestones under our collaboration agreements, our possible inability to execute our strategy due to changes in our industry or the economy generally; changes in productivity and reliability of suppliers; and the success of our competitors and the emergence of new competitors. You should not place undue reliance on forward-looking statements contained in this press release, and we undertake no obligation to publicly update forward-looking statements, whether as a result of new information, future events or otherwise.
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