Journal of Vascular Surgery Publishes Interim Results of RESTORE-CLI Phase 2b Clinical Trial
ANN ARBOR, Mich., June 23, 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 data from the Phase 2b RESTORE-CLI clinical trial of ixmyelocel-T have been published in the peer-reviewed Journal of Vascular Surgery. Richard J. Powell, M.D., section chief of vascular surgery at the Dartmouth-Hitchcock Medical Center in Lebanon, NH, and a principal investigator of the RESTORE-CLI clinical trial, is lead author on the publication.
"The publication of interim data from the RESTORE-CLI trial in the Journal of Vascular Surgery reflects Aastrom's commitment to peer-review and is another important validation of the strong results from our clinical program for ixmyelocel-T. We thank Dr. Powell and all of our investigators for their important and continuing contributions to this effort, and we look forward to initiating our Phase 3 REVIVE-CLI clinical program for ixmyelocel-T in the near future," said Tim Mayleben, president and CEO of Aastrom.
The 6-month interim findings from the RESTORE-CLI Phase 2b clinical trial were reported previously by Aastrom in February 2010 and were also presented at the Society for Vascular Surgery Annual Meeting in June 2010. Aastrom reported the final top line results of this trial in June 2011 and is submitting the full data for presentation at a major medical meeting later this year.
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 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 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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