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| Press Release | Source: Biopure Corporation |
Biopure Receives U.S. Army Grant To Develop Hemopure(R) For Military Trauma Applications Wednesday September 4, 7:30 am ET
CAMBRIDGE, Mass., Sept. 4 /PRNewswire-FirstCall/ -- Biopure Corporation (Nasdaq: BPUR - News ) today announced that it has received a $908,900 grant from the U.S. Department of the Army to develop the company's oxygen therapeutic Hemopure [hemoglobin glutamer - 250 (bovine), or HBOC-201] for potential use in military trauma applications.(*) The Senate and House versions of the FY03 Defense Appropriations Bill, which still must go to a conference committee, recommend additional funding for this project in fiscal 2003.
"World events underscore our armed forces' need for the latest medical technologies," said U.S. Sen. Edward M. Kennedy (D-MA), a member of the Senate Armed Services Committee and Chairman of the Senate Health, Education, Labor and Pensions Committee. "This grant could enhance the military's medical readiness and provide a new approach for treating critically wounded soldiers."
The scope of this Army-sponsored research project is to fund a Phase II randomized, standard therapy-controlled clinical trial evaluating the safety and tolerability of Hemopure in trauma patients; to expand upon ongoing preclinical animal studies for use in the design of future clinical trials; and to develop, in concert with a Trauma Studies Committee of military and civilian experts, a clinical development program for the use of Hemopure in trauma.
"This research project is an important step towards achieving regulatory approval of an oxygen-carrying resuscitative fluid for use in trauma," said U.S. Rep. John Spratt (D-SC), a senior member of the House Armed Services Committee.
Trauma and Resuscitative Fluid Therapy
An estimated 90 percent of soldiers who die from battle injuries never make it to the field hospital. While many of these deaths are not preventable, the single major cause of death in potentially salvageable battlefield casualties is hemorrhage (blood loss). Acute hemorrhage can lead to organ dysfunction, tissue damage and death within minutes unless a transfusion is given to oxygenate tissues and restore lost blood volume. However, blood transfusion is usually not practical in pre-hospital military or civilian trauma settings because stored blood requires refrigeration, is type specific and has a limited shelf life.
At the request of the Office of Naval Research, the Institute of Medicine (IOM) established The Committee on Fluid Resuscitation for Combat Casualties to make recommendations for future research directed at the acute treatment of massive blood loss on the battlefield. The Committee's proposals, which were published in a 1999 IOM book entitled Fluid Resuscitation: State of the Science for Treating Combat Casualties and Civilian Injuries, include a recommendation to "evaluate the applicability of small-volume oxygen-carrying and oxygen-facilitating agents that improve and sustain oxygen delivery in the wounded subject for 24 to 48 hours."
Hemopure
Hemopure is an oxygen therapeutic solution that is stable over a broad temperature range (including room temperature) for three years, is compatible with all blood types, and undergoes a pharmaceutical manufacturing process that ensures consistent purity, potency and stability. The product consists of chemically stabilized bovine hemoglobin in a balanced salt solution. This stabilized hemoglobin is smaller than red blood cells, circulates in plasma (the fluid part of blood), and has a lower viscosity (resistance to flow) and more readily releases oxygen to tissues than blood. Consequently, it has been shown to carry oxygen at low pressure and through constricted or partially blocked blood vessels.
Hemopure is approved in the Republic of South Africa for the treatment of adult surgical patients who are acutely anemic and for the purpose of eliminating, delaying or reducing the need for allogenic red blood cell transfusion in these patients. Biopure has submitted an application to the U.S. Food and Drug Administration (FDA) to market Hemopure in the United States for a similar indication in orthopedic surgical patients, and it plans to file applications in Europe and other markets. The company's veterinary product Oxyglobin [hemoglobin glutamer - 200 (bovine), or HBOC-301], the only oxygen therapeutic approved by the FDA and the European Commission, is indicated for the treatment of anemia in dogs.
Biopure Corporation
Biopure Corporation, headquartered in Cambridge, Mass., is a leading developer, manufacturer and marketer of oxygen therapeutics, a new class of pharmaceuticals that are intravenously administered to deliver oxygen to the body's tissues, for the treatment of acute anemia and other potential medical applications.
The content of this press release does not necessarily reflect the position or the policy of the Government, and no official endorsement should be inferred. Statements in this press release that are not strictly historical are forward-looking statements. Actual results may differ from those projected in forward-looking statements due to risks and uncertainties that exist in the company's operations and business environment. These risks include, without limitation, the company's stage of product development, history of operating losses and accumulated deficits, uncertainties and possible delays related to the filing and acceptance of applications to the FDA and foreign regulatory authorities or related to regulatory clearances for new or revalidated manufacturing facilities, the uncertainties of clinical trials, possible healthcare reform, manufacturing capacity, marketing, market acceptance, competition and the availability of sufficient financing to support operations. Discussions of Biopure's operations and financial condition, and specific factors that could cause the company's actual performance to differ from current expectations, can be found on the company's Web site at http://www.biopure.com/corporate/legal/home_legal.htm and in the company's filings with the U.S. Securities and Exchange Commission, which can be accessed in the EDGAR database at the SEC Web site, http://www.sec.gov , or through the Investor section of Biopure's Web site, http://www.biopure.com .
Contact: Douglas Sayles Jonathan Fassberg (investors) Director The Trout Group Corporate Communications (212) 477-9007 x16 Biopure Corporation Brad Miles (media) (617) 234-6826 BMC Communications [email protected] (212) 477-9007 x17
Source: Biopure Corporation
Edited by - Scully on 27 September 2002 21:54:27