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ANGIOTECH PHARMACEUTICALS AND PARTNER ATHERSYS ANNOUNCE UPDATED RESULTS FROM PHASE I STUDY OF MULTISTEM(R) IN HEART ATTACK PATIENTS


News provided by

Angiotech Pharmaceuticals, Inc.

Sep 23, 2010, 02:30 ET

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VANCOUVER, Sept. 23 /PRNewswire-FirstCall/ - Angiotech Pharmaceuticals, Inc. (NASDAQ: ANPI, TSX: ANP) ("Angiotech") and partner Athersys, Inc. (NASDAQ: ATHX) announced updated results from its phase I clinical trial of MultiStem(R), its allogeneic cell therapy product, administered to individuals following acute myocardial infarction (AMI), more commonly referred to as a heart attack. The updated study results were presented at the Transcatheter Cardiovascular Therapeutics (TCT) Conference held in Washington, D.C. 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(less than)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 additional data from this phase I study further supports the safety profile of MultiStem as potential treatment to improve cardiac function after AMI," said William Hunter, M.D., President and CEO of Angiotech. "We look forward to working with our partner, Athersys, to further develop this exciting technology."

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.

    Forward Looking Statements
    --------------------------

Statements contained in this press release that are not based on historical fact, including without limitation statements containing the words "believes," "may," "plans," "will," "estimates," "continues," "anticipates," "intends," "expects" and similar expressions, constitute "forward-looking statements" within the meaning of the 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 the remainder of 2010 and beyond, our strategies or future actions, our targets, expectations for our financial condition and the results of, or outlook for, our operations, research and development and product and drug development. Such forward-looking statements 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. Many such known risks, uncertainties and other 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 in the United States, Canada and the other regions in which we operate; market demand; technological changes that could impact our existing products or our ability to develop and commercialize future products; competition; existing governmental legislation and regulations and changes in, or the failure to comply with, governmental legislation and regulations; availability of financial reimbursement coverage from governmental and third-party payers for products and related treatments; adverse results or unexpected delays in pre-clinical and clinical product development processes; adverse findings related to the safety and/or efficacy of our products or products sold by our partners; decisions, and the timing of decisions, made by health regulatory agencies regarding approval of our technology and products; the requirement for substantial funding to conduct research and development, to expand manufacturing and commercialization activities; and any other factors that may affect our performance. In addition, our business is subject to certain operating risks that may cause any results expressed or implied by the forward-looking statements in this press release to differ materially from our actual results. These operating risks include: our ability to attract and retain qualified personnel; our ability to successfully complete pre-clinical and clinical development of our products; changes in our business strategy or development plans; our 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; our ability to obtain rights to technology from licensors; liability for patent claims and other claims asserted against us; our ability to obtain and enforce timely patent and other intellectual property protection for our technology and products; the ability to enter into, and to maintain, corporate alliances relating to the development and commercialization of our technology and products; market acceptance of our technology and products; our ability to successfully manufacture, market and sell our products; the availability of capital to finance our activities; our ability to restructure and to service our debt obligations; and any other factors referenced in our other filings with the applicable Canadian securities regulatory authorities or the Securities and Exchange Commission ("SEC"). For a more thorough discussion of the risks associated with our business, see the "Risk Factors" section in our annual report for the year ended December 31, 2009 filed with the SEC on Form 10-K, as amended, and our quarterly report for the second quarter of 2010 filed with the SEC on Form 10-Q.

Given these uncertainties, assumptions and risk factors, investors are cautioned not to place undue reliance on such forward-looking statements. Except as required by law, 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 press release to reflect future results, events or developments.

(C)2010 Angiotech Pharmaceuticals, Inc. All Rights Reserved.

About Angiotech Pharmaceuticals

Angiotech Pharmaceuticals, Inc. is a global specialty pharmaceutical and medical device company. 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

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(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 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(R)). Athersys has forged several key strategic alliances and collaborations with leading pharmaceutical and biotechnology companies, including Pfizer, Angiotech and Bristol-Myers Squibb, as well as world-renowned research institutions in the United States and Europe to further develop its platform and products.

SOURCE Angiotech Pharmaceuticals, Inc.

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