Aastrom Bio shares surge after FDA removes hold on clinical trial (ASTM)

Posted in General 
June 18th, 2009

Aastrom Biosciences is a sub $1 stock, but it’s up about 35% in premarket trade after the company said the FDA removed the clinical hold from the company’s mid-stage trial of a treatment for congestive heart failure, allowing patient enrollment in trials to resume.

The company’s Impact-DCM trial is evaluating the use of Cardiac Repair Cells, mixture of stem and progenitor cells derived from a patient’s own bone marrow, for the treatment of a severe form of chronic heart failure.

In May, the U.S. Food and Drug Administration (FDA) decided to put the trial on hold following a patient’s death, at which point Aastrom suspended the trial’s enrollment and patient treatment. But following an investigation, it was determined that the patient’s death was due to disease progression, not the treatment for it.

The company in a statement said that it the company is still on track to complete trial enrollment by year’s end.

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