|Aastrom (NASDAQ: ASTM) To Provide Clinical Update|
|Tuesday, 22 September 2009 03:00|
Aastrom Biosciences, Inc. (Nasdaq:ASTM), a leading developer of autologous adult stem cell treatments for severe chronic cardiovascular diseases, announced today that Dr. Amit N. Patel, Associate Professor of Surgery at the University of Utah School of Medicine and National Principal Investigator of the Company’s U.S. Phase II IMPACT-DCM clinical trial, will provide an overview of Aastrom’s cardiovascular programs at the Transcatheter Cardiovascular Therapeutics (TCT) annual meeting in San Francisco, California.
Dr. Patel’s presentation is part of the session entitled “Session III—Changing the Course of End-Stage Chronic Heart Failure,” and will take place at approximately 3:17 p.m. (PDT) today, September 22, 2009.
Dr. Patel’s presentation at the TCT meeting will include the following updates:
• Cardiac Regeneration:
• U.S. Phase II IMPACT-DCM clinical trial (surgical delivery)
• The IMPACT-DCM trial is the first trial to evaluate the surgical delivery of autologous cells directly into the human heart muscle for the treatment of congestive heart failure associated with dilated cardiomyopathy (DCM) in both ischemic and non-ischemic patients.
• To date, the trial has enrolled 22 patients at five sites across the U.S.
• Consistent with previous guidance, the Company anticipates that patient enrollment will be completed by the end of December 2009.
• Anticipated U.S. Phase II clinical trial for DCM patients (catheter delivery)
• Aastrom is expanding its ongoing clinical program to evaluate Cardiac Repair Cells (CRCs) in the treatment of severe heart failure patients.
• The Company intends to file an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to initiate its second clinical trial to treat DCM patients.
• The second cardiac regeneration trial is designed to explore a catheter-based approach for the delivery of CRCs to treat DCM patients, in addition to the ongoing surgical delivery approach in the IMPACT-DCM trial.
• Vascular Regeneration:
• U.S. Phase IIb RESTORE-CLI clinical trial
• The RESTORE-CLI trial is a prospective, controlled, randomized, double-blind, multi-center clinical trial to treat patients suffering from critical limb ischemia (CLI), the end stage of peripheral arterial disease (PAD).
• To date, the trial has enrolled 74 patients at 21 sites across the U.S.
• Consistent with previous guidance, the Company anticipates reporting interim clinical data during the first quarter of calendar year 2010.
“Aastrom’s current cardiovascular programs provide a powerful base to build upon,” said Dr. Patel. “I’m impressed with Aastrom’s cell-based product and the progress the Company is making in its ongoing cardiac and vascular regeneration clinical trials. The upcoming initiation of a second cardiac regeneration trial demonstrates the commitment Aastrom has made to developing new treatments for these end-stage patients who currently have limited treatment options available to them.”