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Op RESUS is designed as a single-blinded, randomized and controlled trialwith up to 340 evaluable subjects, including operational military and civilianpersonnel (Department of Defense health system eligible). The primary aim ofthe study is to compare the 28-day relative rate of death in patientsreceiving Hemopure versus the group of patients receiving the "standard fluid"for resuscitation (Hextend). Secondary and tertiary outcome measures are alsodefined. All subjects would receive blood transfusions, when indicated, uponavailability.
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A successful completion, if attained, of Op RESUS safety primaryobjectives is expected to support an application to the FDA for allowance toconduct a definitive Phase 3 trial and have potential to improve survival ofhemorrhagic shock casualties.
Under a research agreement with Biopure, the NMRC has had primaryresponsibility for designing, seeking FDA acceptance of and directing apivotal trauma trial. In carrying out that agreement, the Navy designed andsubmitted to the FDA a proposed phase 2/3 trial entitled "Restore EffectiveSurvival in Shock" (RESUS). That trial would have been conducted prehospitalin civilian trauma patients. The trial was placed on clinical hold by the FDAand continues to be on hold following changes intended to address FDAcomments. The newly filed protocol, by incorporating informed consent, isintended to remove requirements attendant to waiver of informed consent. Todate, Congress has appropriated a total of $24.2 million for the developmentof Hemopure.
Biopure Corporation
Biopure Corporation develops, manufactures and markets pharmaceuticals,called oxygen therapeutics that are intravenously administered to deliveroxygen to the body's tissues. Hemopure(R) [hemoglobin glutamer - 250(bovine)], or HBOC-201, is approved for sale in South Africa for the treatmentof surgical patients who are acutely anemic. The Company is developingHemopure for other indications and is supporting the U.S. Navy'sgovernment-funded efforts to develop a potential out-of-hospital traumaindication. Biopure's veterinary product Oxyglobin(R) [hemoglobin glutamer -200 (bovine)], or HBOC-301, the only oxygen therapeutic approved for marketingby both the U.S. Food and Drug Administration and the European Commission, isindicated for the treatment of anemia in dogs. Biopure has sold approximately200,000 units of Oxyglobin since its launch.
Statements in this release that are not strictly historical are forward-looking statements, including any statements implying that any clinical trialwill be initiated and/or carried out to completion or that study results willbe as desired, and any statements that might imply that Hemopure may receivemarketing approval in any jurisdictions other than South Africa or for atrauma indication anywhere. Actual results and their timing may differmaterially from those projected in these forward-looking statements due torisks and uncertainties. These risks include, without limitation,uncertainties regarding the company's financial position, including itslimited cash resources and need to raise additional cap
