CAMBRIDGE, Mass., June 18 /PRNewswire-FirstCall/ -- Biopure Corporation (Nasdaq: BPUR) announced today that the U.S. Naval Medical Research Center (NMRC) has submitted a new protocol for review by the Food and Drug Administration (FDA) for a Phase 2 clinical trial of Hemopure(R) [hemoglobin glutamer - 250 (bovine)], or HBOC-201, for resuscitation of operational casualties with severe traumatic hemorrhagic shock without availability of blood transfusions. The proposed trial hypotheses 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." Subjects will sign an informed consent prospectively. The study is entitled "Operational Restore Effective Survival in Shock (Op RESUS).
Op RESUS is designed as a single-blinded, randomized and controlled trial with up to 340 evaluable subjects, including operational military and civilian personnel (Department of Defense health system eligible). The primary aim of the study is to compare the 28-day relative rate of death in patients receiving Hemopure versus the group of patients receiving the "standard fluid" for resuscitation (Hextend). Secondary and tertiary outcome measures are also defined. All subjects would receive blood transfusions, when indicated, upon availability.
A successful completion, if attained, of Op RESUS safety primary objectives is expected to support an application to the FDA for allowance to conduct a definitive Phase 3 trial and have potential to improve survival of hemorrhagic shock casualties.
Under a research agreement with Biopure, the NMRC has had primary responsibility for designing, seeking FDA acceptance of and directing a pivotal trauma trial. In carrying out that agreement, the Navy designed and submitted to the FDA a proposed phase 2/3 trial entitled "Restore Effective Survival in Shock" (RESUS). That trial would have been conducted prehospital in civilian trauma patients. The trial was placed on clinical hold by the FDA and continues to be on hold following changes intended to address FDA comments. The newly filed protocol, by incorporating informed consent, is intended to remove requirements attendant to waiver of informed consent. To date, Congress has appropriated a total of $24.2 million for the development of Hemopure.
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 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
clinical trial will be initiated and/or carried out to completion or that
study results will be as desired, and any statements that might imply that
Hemopure may receive marketing approval in any jurisdictions other than
South Africa or for a trauma indication anywhere. 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, the company's ability to satisfactorily address the
issues raised in the MHRA correspondence or additional issues raised at a
later date, 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 June 16, 2008, as
amended on June 18, 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: Tiana Gorham
|SOURCE Biopure Corporation|
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