Key Developments For Aastrom Biosciences Inc
Aastrom Biosciences Inc (ASTM.O) (Consolidated Issue listed on NASDAQ Capital Market)
Aastrom Biosciences, Inc. To Initiate Second Phase II Clinical Trial For Treatment of Severe Chronic Heart Failure
Aastrom Biosciences, Inc. announced that the Company will initiate its second clinical trial for the treatment of dilated cardiomyopathy (DCM), a severe disease associated with chronic heart failure, after a positive 30-day review of Aastrom's Investigational New Drug (IND) submission by the U.S. Food & Drug Administration (FDA). This second trial is a 24 patient U.S. Phase II clinical trial to evaluate the catheter delivery of Cardiac Repair Cells (CRCs) for the treatment of DCM. The new trial expands the Company's cardiovascular program that includes a U.S. Phase II IMPACT-DCM clinical trial evaluating the direct surgical delivery of CRCs. The randomized, controlled, prospective, open-label, Phase II study will seek to enroll 12 patients with ischemic DCM and 12 patients with non-ischemic DCM at two clinical sites in the U.S. Participants must have a left ventricular ejection fraction of less than or equal to 30% (60-75% is typical for a healthy person) and meet certain other eligibility criteria. All 24 patients will receive standard medical care and 16 of the patients (8 ischemic and 8 non-ischemic) will also be treated with CRCs via catheter injection. While the primary objective of this study is to assess the safety of CRCs delivered by catheter injection in patients with DCM, efficacy measures including heart failure stage and cardiac function parameters will also be assessed. Patients will be followed for 12 months post treatment.
Aastrom Biosciences, Inc. Announces Transitions in Senior Management
Aastrom Biosciences, Inc. announced that George W. Dunbar, currently Chief Executive Officer (CEO), President, Chief Financial Officer (CFO) and a Director of Aastrom, will transition out of day-to-day management and is expected to assume the role of Chairman of the Board immediately after the Company's Annual Meeting of Shareholders, currently planned for December 14, 2009. Timothy M. Mayleben, a member of the Company's Board of Directors and current Chair of the Audit Committee, will remain a Director and will become the new Chief Executive Officer, President and CFO in December 2009. Nelson M. Sims, who has served with distinction as Chairman of the Board of Directors since October 2008, is expected to assume the role of Lead Director.
Aastrom Biosciences, Inc. Announces FDA Lifts Clinical Hold From Heart Study-Reuters
Reuters reported that Aastrom Biosciences, Inc. said U.S. health regulators removed the clinical hold from the Company's mid-stage trial of a treatment for congestive heart failure. The Company said it would resume patient enrollment at all five initiated clinical sites. The FDA, the clinical site's principal investigator and an independent Data Safety Monitoring Board (DSMB) attributed the patient's death to progression of the disease and determined it was unrelated to the CRC treatment.
Aastrom Biosciences, Inc. Places Phase II IMPACT-DCM Clinical Trial On Hold Following Report Of Serious Adverse Event
Aastrom Biosciences, Inc. announced that it has temporarily suspended enrollment and patient treatment in its U.S. Phase II IMPACT-DCM clinical trial following a report that a patient died at home after being released from the hospital following treatment in the trial. The patient's cause of death has not yet been determined and is the subject of a pending investigation at the clinical site. An independent Data Safety Monitoring Board (DSMB) will also assess the circumstances of the event. In accordance with standard operating procedures, the Company has informed the U.S. Food and Drug Administration (FDA) of the following: the death of the patient after being released from the hospital; the initiation of an investigation into the cause of death; and that the Company has voluntarily suspended patient enrollment and treatment in the trial. Subsequently, the FDA placed the trial on temporary clinical hold pending an investigation. Follow-up of patients previously enrolled in the IMPACT-DCM trial will continue in accordance with study protocol.
FDA Removes Clinical Hold From Aastrom Biosciences, Inc. Phase II IMPACT-DCM Clinical Trial
Aastrom Biosciences, Inc. announced 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 the four 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. The FDA informed the Company that it had completed its review of the Company's response to the issue cited in the FDA clinical hold letter and that the clinical hold had been lifted; therefore, the IMPACT-DCM clinical trial could resume. To date, nine of 40 patients have been enrolled in the IMPACT-DCM trial at the first three sites. Activation of the fifth clinical site is underway.
