Aastrom to Present Results of Phase 2a Clinical Trial of Ixmyelocel-T in Dilated Cardiomyopathy Patients at SCAI Scientific Sessions
ANN ARBOR, Mich., May 7, 2012 (GLOBE NEWSWIRE) -- Aastrom Biosciences, Inc. (Nasdaq:ASTM), the leading developer of patient-specific, expanded multicellular therapies for the treatment of severe, chronic cardiovascular diseases, today announced that results from the company's Phase 2a clinical trial of ixmyelocel-T in the treatment of dilated cardiomyopathy (DCM) will be presented at the Society for Cardiovascular Angiography and Interventions (SCAI) Scientific Sessions held May 9-12, 2012 in Las Vegas, Nevada. The Aastrom presentation, entitled "Safety and Efficacy of Ixmyelocel-T, An Expanded Patient-Specific Mixed Cell Therapy, in Dilated Cardiomyopathy," will be made on Thursday, May 10, at 12:26 p.m. during the late-breaking clinical trials session. The presentation will be given by Timothy D. Henry, MD, FACC, director of research at the Minneapolis Heart Institute Foundation.
The Phase 2a clinical trial was designed to evaluate the safety and efficacy of intramyocardial delivery of ixmyelocel-T, Aastrom's investigational, patient-specific, multicellular therapy expanded from a patient's own bone marrow. Ixmyelocel-T is comprised of many of the same cell types as those found in the bone marrow and, importantly, expanded populations of CD90+ mesenchymal stromal cells (MSCs) and CD14+auto+ M2 macrophage cells. Ixmyelocel-T provides multiple reparative activities including resolution of chronic inflammation, remodeling of ischemic tissue and promotion of angiogenesis.
In this study, ixmyelocel-T was evaluated in ischemic and non-ischemic DCM patients with class III/IV heart failure as defined by the New York Heart Association and with limited treatment options. The study included 22 patients who were randomized 2 to 1 and followed for 12 months.
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About Aastrom Biosciences
Aastrom Biosciences is the leader in developing patient-specific, expanded multicellular therapies for use in the treatment of patients with severe, chronic cardiovascular diseases. The company's proprietary cell-processing technology enables the manufacture of ixmyelocel-T, a patient-specific multicellular therapy expanded from a patient's own bone marrow and delivered directly to damaged tissues. Aastrom has advanced ixmyelocel-T into late-stage clinical development, including a Phase 3 clinical program to study patients with critical limb ischemia and two Phase 2 clinical trials in patients with ischemic dilated cardiomyopathy. For more information, please visit Aastrom's website at www.aastrom.com. For more information on the pivotal REVIVE Phase 3 clinical trial, please visit the trial website at www.revivecli.com.
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This document contains forward-looking statements, including, without limitation, statements concerning clinical trial plans and progress, objectives and expectations, clinical activity timing, intended product development, the performance and contribution of certain individuals and expected timing of collecting and analyzing treatment data, all of which involve certain risks and uncertainties. These statements are often, but are not always, made through the use of words or phrases such as "anticipates," "intends," "estimates," "plans," "expects," "we believe," "we intend," and similar words or phrases, or future or conditional verbs such as "will," "would," "should," "potential," "could," "may," or similar expressions. Actual results may differ significantly from the expectations contained in the forward-looking statements. Among the factors that may result in differences are the inherent uncertainties associated with clinical trial and product development activities, regulatory approval requirements, competitive developments, and the availability of resources and the allocation of resources among different potential uses. These and other significant factors are discussed in greater detail in Aastrom's Annual or Transition Report on Form 10-K or 10-K/T, Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. These forward-looking statements reflect management's current views and Aastrom does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this release except as required by law.
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