Hemoglobin glutamer 250 bovine (HbO2 Therapeutics)

CAMBRIDGE, Mass., Dec. 20 /PRNewswire-FirstCall/ -- Biopure Corporation announced today that the Navy is in discussions with the Food and Drug Administration (FDA) regarding potential protocol revisions to its previously proposed RESUS Phase IIb/III pre-hospital trauma trial of Hemopure(R) [hemoglobin glutamer - 250 (bovine)] that could enable RESUS to proceed as a smaller, Phase II trial, subject to FDA approval. The Navy and the FDA communicated following last week's meeting of the FDA Blood Products Advisory Committee (BPAC), at which BPAC members discussed possible protocol modifications. As previously announced, the BPAC voted 11 to 8, with one abstention, against proceeding with the proposed 1100-patient, RESUS Phase IIb/III trial. Committee members suggested that, in view of the product's potential benefit in this patient population, RESUS be modified as a pre-hospital Phase II study designed to provide safety and efficacy data in a few hundred patients. "The BPAC meeting was very productive in that it identified a path forward for the study of Hemopure as an emergency pre-hospital treatment until patients can receive blood or other standard treatment at a hospital," said Biopure President and CEO Zafiris G. Zafirelis. "RESUS is designed to assess whether Hemopure can improve survival in trauma patients who have a high risk of death, possibly greater than fifty percent, under the current standard of care." Over the next several weeks, Biopure plans to work with the Naval Medical Research Center (NMRC), which is sponsoring RESUS, to revise the study protocol and investigational new drug (IND) application for resubmission to the FDA and, subsequently, to the NMRC's own institutional review board. The trial will be modified as a Phase II study comprising a few hundred patients. Other changes to consider, based on the BPAC discussion, include adjusting the trauma score, age inclusion criteria, and pre-hospital transportation time. The BPAC also discussed incorporating some military operational aspect into the Navy's trauma development program for Hemopure. RESUS (Restore Effective Survival in Shock) RESUS is a government-funded study designed as a single-blinded, multi- center, randomized, controlled clinical trial. The objective is to evaluate the safety and efficacy of Hemopure, as compared with standard treatment, in reducing morbidity and mortality in severely injured patients experiencing hemorrhagic shock (acute blood loss) in the out-of-hospital setting, where blood is not available for transfusion. Patients would be randomized to receive either Hemopure or standard therapy (crystalloid solution) at the scene of the injury and during transport to the hospital. All patients would receive standard therapy (blood transfusion if indicated) upon arrival at the hospital. Because patients would be unconscious or traumatized, the trial design would provide an exception from informed consent and a community consultation and disclosure process, as defined in FDA regulation 21 CFR 50.24. In order for RESUS to proceed, the FDA must lift its clinical hold and the Department of Defense and the institutional review boards of participating hospitals in the communities where the study would take place must provide final authorization. Out-of-Hospital Fluid Resuscitation Traumatic injuries may cause massive bleeding resulting in rapid loss of oxygen-carrying capacity. The current standard of care for acute hemorrhage outside of the hospital is fluid resuscitation with crystalloids or colloids, which replace lost blood volume but do not carry oxygen. These resuscitative fluids may not sufficiently extend survival in trauma casualties, particularly when evacuation to a hospital is delayed or prolonged. Blood transfusion provides both volume and oxygen-carrying support, but is rarely practical in the field because stored blood requires refrigeration, is type specific and has a limited shelf life. If safety and effectiveness can be demonstrated and regulatory approval obtained, Biopure believes that the compatibility with all blood types, long- term stability without refrigeration (3 years at 35.6 to 86 degrees Fahrenheit, 18 months at 104 degrees Fahrenheit) and other properties of Hemopure could allow it to be stockpiled, positioned abroad, and carried or 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. Biopure Corporation 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. Biopure has applied in the United Kingdom for regulatory approval of a proposed orthopedic surgical anemia indication. The company is developing Hemopure for a potential indication in cardiovascular ischemia, in addition to 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 by the U.S. Food and Drug Administration and the European Commission, is indicated for the treatment of anemia in dogs. Biopure has sold approximately 180,000 units of Oxyglobin, which have been used to treat an estimated 98,000 animals. Statements in this press release that are not strictly historical are forward-looking statements, including any statements regarding the expected size of the next clinical trial or future actions by the NMRC and any statements that might imply that the proposed RESUS trauma trial will receive authorization to proceed. Actual results and their timing may differ materially from those projected in these forward- looking statements due to risks and uncertainties. These risks include, without limitation, uncertainties regarding the company's financial position, unexpected costs and expenses, delays and determinations by regulatory authorities, and delays in or unpredictable outcomes of clinical trials. The company undertakes no obligation to release publicly the results of any revisions to these forward- looking statements to reflect events or circumstances arising after the date hereof. A full discussion of the company's operations and financial condition can be found in the company's filings with the U.S. Securities and Exchange Commission, including under the heading "Risk Factors" in the Form 10-Q filed on September 11, 2006, which can be accessed in the EDGAR database at the SEC Web site, . The content of this press release does not necessarily reflect the position or the policy of the U.S. Government or the Department of Defense, and no official endorsement should be inferred. Contact: Douglas Sayles Biopure Corporation (617) 234-6826 IR@biopure.com Herb Lanzet (Investors) H.L. Lanzet Inc. (212) 888-4570 lanzet@aol.com Biopure Corporation CONTACT: Douglas Sayles of Biopure Corporation, +1-617-234-6826,IR@biopure.com, or, Herb Lanzet of H.L. Lanzet Inc, Investors,+1-212-888-4570, lanzet@aol.com Web site: Company News On-Call: