Aastrom Announces Key Manufacturing Milestone and New Generic Name for Its Cell Therapy Product
ANN ARBOR, Mich., April 4, 2011 (GLOBE NEWSWIRE) -- Aastrom Biosciences, Inc. (Nasdaq:ASTM), a leading developer of expanded, patient-specific cellular therapies for the treatment of severe, chronic cardiovascular diseases, announced today that it has completed an important product manufacturing milestone with the transfer of cell cassette manufacturing to ATEK Medical under the strategic partnership announced in October 2010. These single-use cell cassettes are the central component used in Aastrom's proprietary culturing process at its cell manufacturing facility in Ann Arbor, Michigan.
"As a result of this milestone, which we achieved ahead of schedule, we now have a fully validated and reliable manufacturing partner to support our late stage clinical development programs," said Tim Mayleben, president and CEO of Aastrom. "This will ensure that Aastrom has the inventory of high-quality cell cassettes necessary for the planned mid-2011 start of our Phase 3 clinical program in critical limb ischemia."
In addition, Aastrom announced today that ixmyelocel-T has been formally accepted by the U.S. Food and Drug Administration's Center for Biologics Evaluation and Research and the United States Adopted Names Council as the non-proprietary name for Aastrom's investigational cell therapy product.
"We also reached an important product development milestone with the selection of ixmyelocel-T as the generic name of our expanded cell therapy product," Mr. Mayleben added. "This name was reviewed and accepted by the FDA and USAN Council and will be used by us and our collaborators going forward."
About Aastrom Biosciences
Aastrom Biosciences is developing expanded patient-specific cellular therapies for use in the treatment of severe, chronic cardiovascular diseases. The company's proprietary cell-processing technology enables the manufacture of mixed-cell therapies expanded from a patient's own bone marrow and delivered directly to damaged tissues. Aastrom has advanced its cell therapies into late-stage clinical development, including a planned Phase 3 clinical program for the treatment of patients with critical limb ischemia and two ongoing 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 Report on Form 10-K, 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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