FDA Advises US Navy That It May Not Initiate A Clinical Trial of Biopure's Product Hemopure

December 30, 2008 5:30 PM EST

Biopure Corporation (Nasdaq: BPUR) announced that the FDA has advised the U.S. Naval Medical Research Centerby letter that it may not initiate a clinical trial of Biopure's product Hemopure, under a proposed protocol submitted to the FDA on November 21, 2008. As previously announced, the Navy had filed a protocol for a proposed trial for the resuscitation of operational casualties with severe hemorrhagic shock without availability of blood transfusions.

While the FDA letter acknowledges that the proposed trial addresses some of FDA's concerns previously communicated, it gives three regulatory bases for the hold: safety of subjects, protocol design deficient to meet its stated objectives; and the content of the investigator brochure (a summary of information for those carrying out the trial) and related items. Concerning safety, the FDA hold letter refers to the risk of exacerbation of bleeding resulting from product infusion and the "adverse event profile of [Hemopure]." However, the letter refers in particular to the results of three previous trauma trials with adverse mortality rates, none of which was a Hemopure trial and one of which, according to the FDA, did not involve a hemoglobin based oxygen carrier. According to the FDA, based on these trials with other products, it cannot presently approve IND protocols with agents that may raise blood pressure in acute hemorrhagic shock.

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Biopure Corporation develops, manufactures and markets pharmaceuticals, called oxygen therapeutics that are intravenously administered to deliver oxygen to the body's tissues.

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