Biopure discusses new Hemopure trial with FDA

Just weeks after laying off more than half of its staff, the struggling Cambridge, MA-based Biopure said that it's been in talks with the FDA on identifying an acceptable population of patients for a new trial involving the controversial blood substitute Hemopure. Biopure wants to mount a trial of AML patients who refuse transfusion with blood components.

"Currently, AML patients who do not accept blood transfusions are unable to undergo potentially life-saving induction chemotherapy because of the profound anemia the chemotherapy causes," the company said in a statement.

Biopure and others in the same field have been dogged by controversy, though. A JAMA article last April noted a heightened risk of death and heart attack for patients taking part in blood substitute trials. And a former CMO complained that he was forced to leave the company in 2000 after executives refused to let him tell the FDA that one of its trials should be stopped, according to the AP. Biopure's management has since changed.  

- see Biopure's statement
- read the AP report
- read the story from the Boston Globe

Related Articles:
Expert panel rejects pleas for Hemopure trial
FDA cancels hearing on Hemopure
FDA puts Hemopure trial on hold as it reviews safety
FDA reconsiders non-consent trial of Hemopure