Biopure says FDA to consult advisory committee on 'Resus' Hemopure trial

By Elaine Rigoli

Tampa, Fla., March 13 - Biopure Corp. said the Food and Drug Administration has notified the Navy of its intent to consult an FDA advisory committee within six months to discuss the Navy's proposed "Resus" clinical trial of Biopure's oxygen therapeutic Hemopure for out-of-hospital treatment of hemorrhagic shock resulting from traumatic injury.

The Investigational New Drug application for Resus that the Naval Medical Research Center submitted to the FDA in June 2005 remains on clinical hold because of issues related to the predicted risk-benefit profile of the product under the proposed protocol, according to a company news release.

The FDA has requested additional information, clarification and comment on completed animal studies, the Resus protocol and other aspects of the IND. The FDA also requested changes to the protocol and investigators' brochure, the release said.

Resus (Restore Effective Survival in Shock) is designed as a single-blinded, multi-center, randomized, controlled phase 2b/3 clinical trial.

The objective is to assess the safety and efficacy of Hemopure, as compared with standard treatment, in reducing morbidity and mortality in severely injured patients experiencing acute blood loss where blood is not available for transfusion, the release said.

If safety and effectiveness can be demonstrated and regulatory approval obtained, Biopure said the compatibility with all blood types, long-term stability without refrigeration and other Hemopure properties could allow it to be stockpiled, positioned abroad and stored in remote locations for use as an oxygen-carrying resuscitative fluid when blood is not available.

These attributes may make it well suited for use on the battlefield, in ambulances, and in the Strategic National Stockpile, the release said.

"We continue to believe that the product's risk-benefit profile, as an emergency pre-hospital treatment until patients can receive blood or other standard treatment at a hospital, supports allowing Resus to proceed," said Biopure chairman and chief executive officer Zafiris G. Zafirelis, in a statement.

"We are working with [the Naval Medical Research Center] and its Resus advisory board to further address FDA's concerns so this important study can ultimately move forward."

Biopure develops pharmaceuticals, called oxygen therapeutics, that are intravenously administered to deliver oxygen to the body's tissues. The company has headquarters in Cambridge, Mass.

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