CAMBRIDGE, Mass., Dec. 2 /PRNewswire-FirstCall/ -- Biopure Corporation announced today that the U.S. Naval Medical Research Center (NMRC) has submitted to the Food and Drug Administration (FDA) a revised investigational new drug (IND) application to conduct a clinical trial of the company's oxygen therapeutic Hemopure(R) [hemoglobin glutamer - 250 (bovine)] for the pre-hospital battlefield treatment of trauma patients. The study is entitled "Operation Restore Effective Survival in Shock" (Op RESUS).
As previously reported, 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
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.
Statements in this release that are not strictly historical are forward-looking statements, including any statements implying that any proposed trial will be permitted to proceed by the FDA or that if a trial is undertaken the results will be as expected. 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, including its limited cash resources and need to raise additional capital to pursue its business, unexpected costs and expenses, delays and adverse determinations by regulatory authorities, unanticipated problems with the product's commercial use, whether or not product related, and with product distributors, sales agents or other third parties, delays in clinical trials, and the other factors identified under the heading "Risk Factors" in the Company's quarterly report on Form 10-Q filed on September 15, 2008, which can be accessed in the EDGAR database at the U.S. Securities and Exchange Commission's (SEC) website, http://www.sec.gov/. 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 SEC.
Contact: Rob Skiba
Biopure Corporation
(617) 234-6500
