Aastrom's shares are up on the news that the FDA has lifted a clinical hold on the company's Phase II congestive heart failure trial. The trial is testing cardiac repair cells (CRC), which contain stem and early progenitor cells extracted from the patient's marrow. The hold was put in place last month after a patient died at home after being released from the treatment facility. The FDA, the clinical site's principal investigator and an independent Data Safety Monitoring Board concluded the death was caused by the progression of the disease, not the CRC treatment. Aastrom's shares shot up 39 percent in pre-market trading.
"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," said George Dunbar, President and CEO Aastrom.
This is the second time a clinical hold has been put in place and subsequently lifted. Another hold was put in place earlier this year after a patient in the CRC study experienced a severe adverse event; the trial resumed in March.
- see Aastrom's release
- read the Reuters article