U.S. Naval Medical Research Center (NMRC) has submitted to the FDA a revised investigational new drug application to begin a clinical trial of Hemopure® [hemoglobin glutamer – 250 (bovine)], a stabilized hemoglobin, for pre-hospital battlefield treatment of trauma patients. The study is entitled “Operation Restore Effective Survival in Shock” (Op RESUS).
The drug, a product of Biopure Corp, a Cambridge, Mass company, has been under development for many years now. At present, Hemopure® has been approved for marketing in South Africa, where it is “indicated for the treatment of adult surgical patients who are acutely anaemic. Hemopure is indicated for the purpose of eliminating, delaying, or reducing the need for allogenic red blood cells.” The company says Hemopure provides “an oxygen treatment bridge” in surgical patients by buying time for patients to build up their own reserves of red blood cells following surgery, hence eliminating the need for red blood cell transfusions in the immediate post operative period.
From the press release:
In June 2008, the NMRC submitted and subsequently withdrew an Op RESUS protocol for a Phase 2 clinical trial of Hemopure for resuscitation of operations casualties with severe traumatic hemorrhagic shock, when blood transfusion is not available. The proposed trial hypothesis is that for such casualties Hemopure will improve survival and other clinical parameters, and will be relatively safe and well tolerated, in comparison with “standard fluid.” If the trial is permitted to proceed, subjects will sign an informed consent prospectively. The revised Op RESUS protocol addresses some of the issues raised by the FDA on the initial filing.
Under a research agreement with Biopure, the NMRC assumed primary responsibility, subject to funding, for designing, seeking FDA acceptance of and directing a trial for Hemopure’s prehospital use in trauma patients with hemorrhagic shock. The NMRC has developed protocols for trials in civilian casualties in the United States and abroad (RESUS) as well as Op RESUS. To date, Congress has appropriated funds for the development of Hemopure for potential use in military and civilian trauma indications and to cover military administrative costs. This funding is being used for trial preparation and for preclinical studies of Hemopure in animal models, including those that mimic military trauma scenarios. RESUS remains on clinical hold, and the Company anticipates that NMRC will also submit an amended version of that protocol.
Biopure Corporation develops, manufactures and markets pharmaceuticals, called oxygen therapeutics that are intravenously administered to deliver oxygen to the body’s tissues. Hemopure(R) [hemoglobin glutamer – 250 (bovine)], or HBOC-201, is approved for sale in South Africa for the treatment of surgical patients who are acutely anemic. On November 21, 2008, the Company announced that it had terminated most of its work force for financial reasons. Using its limited resources, the Company is developing Hemopure for other indications and is supporting the U.S. Navy’s government-funded efforts to develop a potential out-of-hospital trauma indication. Biopure’s veterinary product Oxyglobin(R) [hemoglobin glutamer – 200 (bovine)], or HBOC-301, the only oxygen therapeutic approved for marketing by both the U.S. Food and Drug Administration and the European Commission, is indicated for the treatment of anemia in dogs. Biopure has sold approximately 200,000 units of Oxyglobin since its launch.
Of note, there is a substantial amount of controversy revolving around Hemopure. Biopure, the manufacturer, has filed a lawsuit against Charles Natanson, et al of the NIH regarding a critical article he and colleagues wrote in the May 21st issue of JAMA.
Biopure press release: U.S. Naval Medical Research Center Resubmits…
Slide presentation (.pdf) about Hemopure for clinicians in South Africa…
Hemopure South Africa…
Biopure’s Oxygenation Technology…
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