U.S. Naval Medical Research Center Resubmits IND Application for Proposed 'Op RESUS' Clinical Trial in Trauma Patients in the Battlefield Setting
CAMBRIDGE, Mass., Dec. 2 /PRNewswire-FirstCall/ -- Biopure Corporation
(Nasdaq: BPUR) 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
IR@biopure.com