CLEVELAND, OH and VANCOUVER, Dec. 20 /PRNewswire-FirstCall/ - Athersys, Inc. (Nasdaq: ATHX) and Angiotech Pharmaceuticals, Inc. (NASDAQ: ANPI, TSX: ANP), announced today that Athersys has received authorization from the U.S. Food and Drug Administration (FDA) to begin a Phase I clinical trial evaluating the safety of MultiStem(R) in the treatment of acute myocardial infarction (AMI). The companies believe that this represents the first clinical study of a scalable, allogeneic cell product injected directly into and around the zone of myocardial injury from an intra-coronary approach. This approach is designed to provide the clinician with a readily usable, "off-the-shelf" cell therapy that combines the benefits of efficient, localized delivery and enhanced cell retention in the area of greatest need.
Angiotech and Athersys entered into an agreement in May 2006 to co-develop and commercialize MultiStem(R), Athersys' non-embryonic stem cell platform technology, for use in the indications of AMI and peripheral vascular disease. Upon completion of the Phase I trial, Angiotech will assume lead responsibility for further clinical development. Angiotech also owns marketing and commercial rights with respect to this product candidate.
"Stem cell therapy offers the promise of restoring the functionality of damaged heart tissue, helping patients return to a more normal lifestyle following serious heart attacks. We believe that the MultiStem(R) technology has demonstrated significant promise in the preclinical setting and has the potential to be an effective "off-the-shelf" cell therapy product for the interventional cardiologist," commented Dr. Jeff Walker, Senior VP, Research and Development for Angiotech.
"Building on the success of TAXUS(R) in revolutionizing stenting, we are committed to and excited about the co-development of MultiStem(R)," commented Dr. William Hunter, President and CEO of Angiotech. "2008 brings a wealth of opportunity for Angiotech, with the potential regulatory approvals of our 5-FU CVC in the U.S. and our Vascular Wrap(TM) product in Europe, and with MultiStem(R), the next generation of therapeutics in interventional cardiology, entering the clinic."
The Phase I study will be an open label, multi-center dose escalation trial evaluating the safety and maximum tolerated dose of single dose administration of allogeneic MultiStem(R) following an AMI. Following standard treatment, enrolled patients will receive MultiStem(R) delivered via a microinfusion catheter, and these patients will be evaluated and compared to patients receiving standard-of-care only.
Athersys and Angiotech have both evaluated the safety profile of MultiStem(R), as well as this product candidate's potential to improve heart function in multiple animal models, including well-validated preclinical models of AMI. Based on the Athersys preclinical work, the companies believe that MultiStem(R) can be administered safely and that it may provide substantial functional benefit to patients suffering severe heart attacks.
MultiStem cells are proprietary adult stem cells derived from bone marrow, which have the demonstrated ability to form a wide range of cell types. MultiStem may work through several mechanisms, but a primary mechanism appears to be the production of multiple therapeutic molecules produced in response to inflammation and tissue damage. Athersys believes that MultiStem represents a unique "off-the-shelf" stem cell product based on its apparent ability to be used without tissue matching or immunosuppression and its capacity for large scale production. Based on research conducted by Athersys and its manufacturing partner, Lonza, the company believes that material from a single qualified donor may be used to produce hundreds of thousands or even millions of clinical doses.
Angiotech Pharmaceuticals, Inc. is a global specialty pharmaceutical and medical device company with over 1,500 dedicated employees. Angiotech 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, TSX: ANP), please visit our website at www.angiotech.com.
About Athersys, Inc.
Athersys is a biopharmaceutical company engaged in the discovery and development of therapeutic product candidates designed to extend and enhance the quality of human life. The company's lead product candidate, ATHX-105, is an oral, selective 5HT2c receptor agonist in Phase I clinical trials for the treatment of obesity. The company is developing other 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 is developing MultiStem(R), a patented, adult-derived "off the shelf" stem cell product platform for multiple disease indications, including damage caused by myocardial infarction, bone marrow transplantation/oncology support, ischemic stroke and other indications.
Statements contained in this press release that are not based on historical fact, including without limitation statements containing the words "believes," "may," "could", "plans," "will," "estimate," "continue," "anticipates," "intends," "expects" and similar expressions, constitute "forward-looking statements" within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and constitute "forward-looking information" within the meaning of applicable Canadian securities laws. All such statements are made pursuant to the "safe harbor" provisions of applicable securities legislation. Forward-looking statements may involve, but are not limited to, comments with respect to our objectives and priorities for 2007 and beyond, our strategies or future actions, our targets, our estimation of potential market size, expectations for our financial condition and the results of, or outlook for, our operations, research development and further product and drug development. Such forward-looking statements also involve known and unknown risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such factors are taken into account as part of our assumptions underlying these forward-looking statements and include, among others, the following: general economic and business conditions, both nationally and in the regions in which we operate; technological changes that impact our existing products or our ability to develop and commercialize future products; competition; changes in business strategy or development plans; the ability to attract and retain qualified personnel; existing governmental regulations and changes in, or the failure to comply with, governmental regulations; adverse results or unexpected delays in drug discovery and clinical development processes; failure to obtain patent protection for discoveries; loss of patent protection resulting from third party challenges to our patents; commercialization limitations imposed by patents owned or controlled by third parties; dependence upon, and relationships with strategic alliance partners to develop and commercialize products and services based on our work; our ability to obtain rights to technology from licensors; liability for patent claims and other claims asserted against us; the requirement for substantial funding to conduct research and development and to expand commercialization activities or consummate acquisitions; the size of the market and the potential market for our products in specific disease areas, other factors referenced in our annual information form and other filings with the applicable Canadian securities regulatory authorities or the Securities and Exchange Commission; and any other factors that may affect performance. In addition, our business is subject to certain operating risks that may cause the actual results expressed or implied by the forward-looking statements in this report to differ materially from our actual results. These operating risks include: our ability to successfully complete preclinical and clinical development of our products; the ability to obtain and enforce timely patent and other intellectual property protection for our technology and products; decisions, and the timing of decisions, made by health regulatory agencies regarding approval of our technology and products; the ability to complete and maintain corporate alliances relating to the development and commercialization of our technology and products; market acceptance of our technology and products; the competitive environment and impact of technological change; the continued availability of capital to finance our activities; our ability to integrate into our business the operations of AMI; and, our ability to achieve the operational and other synergies and the other commercial or financial benefits expected as a result of the acquisition of AMI. Given these uncertainties, assumptions and risk factors, readers are cautioned not to place undue reliance on such forward-looking statements. We disclaim any obligation to update any such factors or to publicly announce the result of any revisions to any of the forward-looking statements contained in this report to reflect future results, events or developments.
CONTACT: Angiotech Contacts: Jodi Regts, Senior Manager, Investor Relations and Corporate Communications, Angiotech Pharmaceuticals, Inc., (604) 221-7930, [email protected]; Deirdre Neary, Manager, Investor Relations, Angiotech Pharmaceuticals, Inc., (604) 222-7056, [email protected]; Athersys, Inc. Contacts: William (B.J.) Lehmann, J.D., President and Chief Operating Officer, Athersys, Inc., (216) 431-9900, [email protected]; Lisa M. Wilson, In-Site Communications, (917) 543-9932, [email protected]
SOURCE Angiotech Pharmaceuticals, Inc.