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Print Edition StoriesMonday, March 23, 2009
Navy to try again to get Hemopure trial OKd
By Marc Songini
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The U.S. Naval Medical Research Center has submitted a new request for a trial of ailing Cambridge-based Biopure Corp.’s Hemopure treatment.
Hemopure is the company’s oxygen therapeutic for the pre-hospital treatment of trauma patients. At the end of 2008, the U.S. Food and Drug Administration refused to allow the NMRC to conduct a clinical trial of the product. The Navy’s intent was to use it for the resuscitation of operational casualties with severe hemorrhagic shock without availability of blood transfusions.
Biopure (Nasdaq: BPUR) reports that the NMRC has submitted a revised investigational new drug application to conduct a clinical trial.
The initial request for the study, called “Restore Effective Survival in Shock,” was first proposed and submitted to the FDA in 2005, said Biopure in a statement. It was placed on clinical hold and resubmitted repeatedly in response to FDA comments and to address comments from the FDA Blood Products Advisory Committee at an open meeting held in December 2006. Each subsequent submission was placed on clinical hold.
The company is in a difficult position. Last fall, it terminated most of its work force for financial reasons. It expects its revenue to last on until April, and it has been exploring its options, which could include a potential sale or even a bankruptcy filing.
In its annual report for the year ending Oct. 31, 2008 it noted that it had operating losses in 2008 and 2007 of $20.8 million and $36.9 million. Using its “limited resources,” Biopure is supporting the U.S. Navy’s government-funded efforts to develop a potential out-of-hospital trauma indication, it stated.
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