FDA Advisory Committee To Consider U.S. Navy's Proposed 'RESUS' Trauma Trial At July 2006 Meeting
CAMBRIDGE, Mass., May 26 /PRNewswire-FirstCall/ -- Biopure Corporation announced today that it has been notified by the Food and Drug Administration (FDA) that the FDA's Blood Products Advisory Committee will meet on July 14, 2006 to discuss the Navy's proposed RESUS clinical trial of the company's investigational oxygen therapeutic Hemopure(R) [hemoglobin glutamer - 250 (bovine)] for out-of-hospital treatment of hemorrhagic shock resulting from traumatic injury. FDA has invited the Naval Medical Research Center (NMRC) and Biopure to present at the meeting. As previously announced, NMRC's investigational new drug application (IND) for RESUS is on clinical hold at FDA.
"We believe that the product holds promise as an emergency pre-hospital treatment until patients can receive blood or other standard treatment at a hospital, and we look forward to presenting our data," said Biopure Chairman and CEO Zafiris G. Zafirelis.
The Blood Products Advisory Committee reviews and evaluates available data concerning the safety, effectiveness, and appropriate use of blood products derived from blood and serum or biotechnology which are intended for use in the diagnosis, prevention, or treatment of human diseases, and, as required, any other product for which FDA has regulatory responsibility, and advises the Commissioner of Food and Drugs of its findings regarding the safety, effectiveness, and labeling of the products, on clinical and laboratory studies involving such products, on the affirmation or revocation of biological product licenses, and on the quality and relevance of FDA's research program which provides the scientific support for regulating these agents.
In order for the proposed RESUS trial to proceed, FDA must lift the 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.
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. The product has not been approved for sale in other countries. Biopure plans to apply in Europe, in mid 2006, for approval of an acute anemia indication in orthopedic surgery patients. The company is developing Hemopure for a potential indication in cardiovascular ischemia, in addition to supporting the U.S. Naval Medical Research Center's government-funded development of a potential out-of-hospital trauma indication. The company'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.
Statements in this press release that are not strictly historical are forward-looking statements, including any that might imply that the proposed RESUS trauma trial will receive authorization to proceed. 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, delays and 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, 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 March 13, 2006, 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@email@example.comBiopure Corporation
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