Aastrom Biosciences Announces First Patients Enrolled in ixCELL-DCM Phase 2b Clinical Trial of Ixmyelocel-T
ANN ARBOR, Mich., April 4, 2013 (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 the first patients have been enrolled in the ixCELL-DCM clinical trial. This Phase 2b study is currently underway in the United States to assess the efficacy and safety of ixmyelocel-T in the treatment of patients with advanced heart failure due to ischemic dilated cardiomyopathy (ischemic DCM).
"Enrolling the first patients in the ixCELL-DCM trial is an important milestone in our effort to bring this potential new treatment for advanced heart failure to thousands of people who might benefit from it," said David Recker, M.D., acting chief medical officer at Aastrom Biosciences.
The ixCELL-DCM trial is a randomized, double-blind, placebo-controlled phase 2b study with a planned enrollment of 108 patients at approximately 30 sites in the U.S. In the study, ixmyelocel-T will be administered via catheter-based injections to patients with advanced heart failure due to ischemic DCM. The primary endpoint of the trial will be the average number of events per patient, which include all-cause mortality, all-cause hospitalizations or unplanned hospital visits to treat worsening heart failure. Patients will be followed for a total of 12 months.
"We recently refocused our clinical program on the development of ixmyelocel-T for the treatment of dilated cardiomyopathy and other rare disease indications and are delighted to enroll our first patients in the ixCELL-DCM study," said Nick Colangelo, president and chief executive officer at Aastrom Biosciences. "We have increased the number of sites participating in this study which will help us build momentum in patient enrollment and complete the trial on schedule."
For more information on ischemic DCM and ixmyelocel-T, visit http://www.aastrom.com/cardiovascular-disease-patients/living-with-dcm-video/
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 2b clinical trial in patients with ischemic 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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