Aastrom Biosciences ASTM FDA News - 6/18/09

Shares of Aastrom Biosciences, Inc. (ASTM) are Up 31% to $0.50 in pre market trading ( 6/18/09 ) on the following FDA news below. ASTM is a stem cell stock which trades on the Nasdaq stock exchange. Discuss ASTM

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FDA Allows Aastrom Biosciences to resume Heart Study

FDA Removes Clinical Hold From Aastrom Phase II IMPACT-DCM Clinical Trial

Patient Death Unrelated to Aastrom's CRCs; Trial to Resume At All Clinical Sites for Patients Suffering From Dilated Cardiomyopathy

June 18, 2009 (GLOBE NEWSWIRE) -- Aastrom Biosciences, Inc. (Nasdaq:ASTM), a leading developer of autologous adult stem cell treatments for severe chronic cardiovascular diseases, today reported that the U.S. Food and Drug Administration (FDA) has removed the clinical hold from the Company's U.S. Phase II IMPACT-DCM clinical trial and that patient enrollment would resume at all five initiated clinical sites. The IMPACT-DCM trial is evaluating the use of Cardiac Repair Cells (CRCs), a mixture of stem and progenitor cells derived from a patient's own bone marrow, for the treatment of dilated cardiomyopathy (DCM), a severe form of chronic heart failure.

On June 17, 2009, the FDA informed Aastrom that it had completed its investigation into the death of a patient following treatment with the Company's CRCs and that the clinical hold had been lifted; therefore, the IMPACT-DCM clinical trial could resume. Based on autopsy results and medical records, the FDA, the clinical site's principal investigator and an independent Data Safety Monitoring Board (DSMB) have attributed the patient death to progression of the disease and determined it was unrelated to the CRC treatment.

"Patient safety is top priority for Aastrom. We are saddened by the loss of one of our patients. At the same time, we are grateful that this investigation was conducted in an efficient manner and that the FDA was able to provide prompt review and remove the clinical hold so quickly. This comprehensive review, along with the FDA's permission to carry on the trial without modifications, underscores the safety of the trial design and that our CRC product played no role in the patient's death," stated George W. Dunbar, President and Chief Executive Officer at Aastrom. "We do not expect that this short delay will interfere with our goal of completing patient enrollment in this trial by the end of calendar year 2009. We are eager to resume patient enrollment and treatment in the IMPACT-DCM trial and to continue evaluating the clinical data we gather from these patients." Full Article


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