U.S. Navy To Receive Defense Appropriation For Hemopure(R) Research And Development
CAMBRIDGE, Mass., Jan. 3 /PRNewswire-FirstCall/ -- Biopure Corporation announced today that the FY2006 Defense Appropriations Bill signed by President Bush on December 30, 2005 includes $4 million in additional Congressional funding for the U.S. Navy to continue research and development of Biopure's investigational oxygen therapeutic Hemopure(R) [hemoglobin glutamer -- 250 (bovine)] for potential use in military and civilian trauma applications.
To date, Congress has appropriated a total of $22.5 million to the Navy and Army for the development of Hemopure.* This funding is being used for the Navy's proposed RESUS clinical trial and for preclinical studies of the product in animal models of hemorrhagic shock (acute blood loss), including those that mimic military trauma scenarios.
Under its research agreement with Biopure, the Naval Medical Research Center (NMRC) has primary responsibility for designing, seeking Food and Drug Administration (FDA) acceptance of and conducting a proposed Phase 2/3 clinical trial of Hemopure in trauma patients with severe hemorrhagic shock in the out-of-hospital setting. Entitled "Restore Effective Survival in Shock (RESUS)," this trial represents a unique collaboration between scientists and clinicians from the military, academic hospitals, a nonprofit organization and Biopure under the direction of the NMRC. As previously announced, the NMRC and Biopure are addressing issues raised by the FDA in an effort to lift the clinical hold on the NMRC's investigational new drug application to conduct the RESUS trial.
Traumatic injuries may cause massive bleeding resulting in rapid loss of oxygen-carrying capacity. Due to logistical issues, red blood cells are not typically administered in emergency situations outside of the hospital; emergency caregivers administer intravenous fluids (Ringer's lactate, saline) that restore blood volume but do not carry oxygen. If safety and effectiveness can be demonstrated and regulatory approval obtained, the company believes that the room- and elevated-temperature stability (3 years at 2 to 30 degrees Celsius, 18 months at 40 C), universal compatibility and other properties of Hemopure could allow it to be stockpiled, positioned abroad, and carried or stored in remote locations. These attributes may make it well suited for use on the battlefield, in ambulances, and in the Strategic National Stockpile.
About Biopure Corporation
Biopure Corporation develops, manufactures and markets pharmaceuticals, called oxygen therapeutics, that are intravenously administered to deliver oxygen to the body's tissues. The company is developing Hemopure(R) [hemoglobin glutamer -- 250 (bovine)], or HBOC-201, for a potential indication in cardiovascular ischemia and, in collaboration with the U.S. Naval Medical Research Center, for a potential out-of-hospital trauma indication. The product is approved in South Africa for treating surgery patients who are acutely anemic and for eliminating, delaying or reducing allogeneic red blood cell transfusions in these patients. Hemopure has not been approved for sale in other jurisdictions, including the United States or the European Union. 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.
* $5,102,306 is from Grant DAMD17-02-1-0697. The U.S. Army Medical Research Acquisition Activity, 820 Chandler Street, Fort Detrick MD 21702-5014, is the awarding and administering acquisition office.
Statements in this press release that are not strictly historical are forward-looking statements, including any statements that imply that the FDA might lift the clinical hold on the RESUS trial. Actual results 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, possible delays related to clinical trials, determinations by the FDA, and 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 9, 2005, which can be accessed in the EDGAR database at the SEC Web site, http://www.sec.gov. 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 Herb Lanzet (Investors) Biopure Corporation H.L. Lanzet Inc. (617) 234-6826 (212) 888-4570 IR@firstname.lastname@example.orgBiopure Corporation
CONTACT: Douglas Sayles of Biopure Corporation, +1-617-234-6826,IR@biopure.com; Investors: Herb Lanzet of H.L. Lanzet Inc. for BiopureCorporation, +1-212-888-4570, email@example.com
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