Mental HealthU.S. Naval Medical Research Center Proposed 'RESUS' Clinical Trial In Trauma Patients Remains On FDA Hold
Biopure Corporation (Nasdaq: BPUR) announced that the Food and Drug Administration has advised the U.S. Naval Medical Research Center (NMRC) by letter that it may not initiate a clinical trial of Biopure"s oxygen therapeutic Hemopure(R) [hemoglobin glutamer -- 250 (bovine)] under a proposed protocol submitted to the FDA in March 2009. As previously announced, the study, "Restore Effective Survival in Shock" (RESUS) was first proposed and submitted to the FDA in 2005. The proposed trial was placed on clinical hold at that time. It has been resubmitted repeatedly in response to FDA comments and to address comments made by the FDA Blood Products Advisory Committee at an open meeting held in December 2006. Each subsequent submission, including the most recent, was placed on clinical hold.
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 used in trauma patients with hemorrhagic shock. The NMRC has also developed and submitted a protocol for a trial proposed to be conducted in the field, called Operation RESUS (OP RESUS). 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 fluids." Op RESUS is also on clinical hold, and the company does not expect the FDA to permit RESUS or OP RESUS to proceed in the foreseeable future.
The company expects the NMRC to seek FDA approval for a clinical trial of Hemopure with a concomitant drug to address vasoactivity, which occurs with the use of Hemopure alone. The NMRC and the FDA are in discussions concerning such a trial, and the NMRC is conducting preclinical studies recommended by the FDA to prepare for such a trial. The NMRC continues to buy Hemopure for this testing.
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.
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 res, the Company 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.
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 and viability, unexpected costs and expenses, delays and adverse determinations by regulatory authorities and unanticipated problems with the product"s commercial use, whether or not product related, and the other factors identified under the heading "Risk Factors" in the Company"s annual report on Form 10-K/A filed on March 3, 2009, 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.
Biopure Corporation