Wednesday, December 31, 2008

FDA blocks Naval trial of Hemopure

By Brendan Lynch

The U.S. Food and Drug Administration has refused to allow the U.S. Naval Medical Research Center to conduct a clinical trial of Biopure Corp.’s Hemopure product, according to the company.

The U.S. Navy had filed for a clinical trial for the resuscitation of operational casualties with severe hemorrhagic shock without availability of blood transfusions (“Op RESUS”).

The FDA said in a letter that it refused the trial for three reasons: the safety of the trial’s subjects, a protocol design deficient in meeting its stated objectives and the content of the investigator brochure and related items. The FDA’s safety concern refers to the risk of exacerbation of bleeding resulting from Hemopure’s infusion and the “adverse event profile of [Hemopure].” Biopure (Nasdaq: BPUR) says the safety concern stems from clinical trials of similar products but not Hemopure. Based on those trials, the FDA has told Biopure it cannot approve IND protocols with agents that may raise blood pressure in acute hemorrhagic shock.

Biopure has undergone several months of lawsuits and tribulations involving its stock listing. Most recently, Biopure announced that the Nasdaq Stock Market suspended enforcement of its March 16, 2009 deadline to regain compliance with minimum bid rules until April 20. The company’s original extension deadline of Dec. 8, 2008, was pushed back because of “turmoil in the marketplace,” Biopure officials reported. The company also filed a trade libel lawsuit against a senior investigator for the National Institutes of Health in October, alleging the investigator’s actions of co-authoring an article in the Journal of the American Medical Association, and writing letters to regulatory authorities caused injury to Biopure.

Cambridge-based Biopure develops, manufactures and markets pharmaceuticals called oxygen therapeutics that are intravenously administered and intended to deliver oxygen to the body’s tissues.