ANN ARBOR, Mich., Oct. 3, 2011 (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 it has been granted a key composition of matter patent from the European Patent Office. The patent provides protection throughout the European Union for ixmyelocel-T, the company's investigational product currently in clinical development for the treatment of critical limb ischemia (CLI) and dilated cardiomyopathy (DCM).
The issued patent, Mixed Cell Populations for Tissue Repair and Separation Technique for Cell Processing, provides protection for various claims regarding "an isolated cell composition…comprising a mixed population of cells of hematopoietic, mesenchymal and endothelial lineage," which characterizes the ixmyelocel-T product. The company's patented single-pass perfusion technology enables the production of ixmyelocel-T through selective expansion of specific cell populations which have been shown in preclinical and clinical studies to reduce inflammation (which is associated with atherosclerotic vascular disease), remodel ischemic tissue, and promote the formation of new blood vessels.
"Together with the approval of a U.S. composition-of-matter patent in January 2011, this key patent approval in the EU significantly expands our intellectual property estate for ixmyelocel-T. As we continue to advance ixmyelocel-T through the final stages of clinical development, these patents provide strong protection for our commercial interests and for future global development and commercialization partners for ixmyelocel-T," said Tim Mayleben, president and CEO of Aastrom Biosciences.
This quarter, Aastrom plans to initiate a Phase 3 pivotal clinical trial for ixmyelocel-T in the treatment of patients with CLI who have no options for revascularization. The company also plans to initiate a Phase 2b clinical trial for ixmyelocel-T in the treatment of DCM in 2012.
About Aastrom Biosciences
Aastrom Biosciences is developing patient-specific, expanded multicellular therapies for use in the treatment of 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 planned Phase 3 clinical program to study patients with critical limb ischemia and two Phase 2 clinical trials in patients with dilated cardiomyopathy. For more information, please visit Aastrom's website at www.aastrom.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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