CAMBRIDGE, Mass., Nov. 30 /PRNewswire-FirstCall/ -- Biopure Corporation
(Nasdaq: BPUR) announced today that, on November 28, 2005, representatives of
the Navy, Biopure and the Food and Drug Administration (FDA) met to discuss
the Navy's proposed "RESUS" clinical trial of Hemopure(R) [hemoglobin glutamer
- 250 (bovine)] for the out-of-hospital treatment of hemorrhagic shock in
trauma patients. As previously reported, the Navy's investigational new drug
application (IND) to conduct this trauma trial is currently on hold at the
FDA, primarily due to the agency's concerns about the risk-benefit profile in
this patient population.
At the meeting, military and academic trauma experts from the Navy's RESUS
advisory board addressed the FDA's concerns and presented the medical and
scientific basis for proceeding with the trial. A senior official from the
FDA Center for Biologics Evaluation and Research (CBER) is further examining
the risk-benefit profile to assess whether the risks associated with the
clinical trial are reasonable in light of what is known about the preclinical
and clinical profile of Hemopure. To facilitate this review, the FDA
requested a summary of data supporting the Navy's position for moving forward
with the trial.
Biopure continues to work with the Naval Medical Research Center and
expects to provide further updates regarding the regulatory status of RESUS in
2006.
RESUS (Restore Effective Survival in Shock) is designed as a single-
blinded, multi-center, randomized, controlled, Phase 2b/3 clinical trial.
Patients would be randomized to receive either Hemopure or standard therapy
(crystalloid solution) at the scene of the injury and during transport to the
hospital. The trial would require an exception from informed consent and
would include a community consultation and disclosure program as defined in
federal regulations 21 CFR 50.24-25.
Biopure Corporation
Biopure Corporation develops and manufactures intravenously administered
pharmaceuticals, called oxygen therapeutics, that deliver oxygen to the body's
tissues. The company is developing Hemopure(R) [hemoglobin glutamer - 250
(bovine)], or HBOC-201, for a potential indication in cardiovascular ischemia
and, in collaboration with the U.S. Naval Medical Research Center, for an out-
of-hospital trauma indication. The product is approved in South Africa for
treating surgery patients who are acutely anemic and for eliminating, delaying
or reducing allogeneic red blood cell transfusions in these patients. Hemopure
has not been approved for sale in other jurisdictions, including the United
States or the European Union. Biopure'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 statements that imply that the FDA
might lift the clinical hold on the RESUS trial. 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, possible delays related to clinical trials, determinations by the
FDA, and 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, and specific factors that could cause the company's actual
performance to differ from current expectations, 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 September 9, 2005, 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
Biopure Corporation
(617) 234-6826
IR@biopure.com
SOURCE Biopure Corporation
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Related links:
http://www.biopure.com
Company News On-Call:
http://www.prnewswire.com/comp/131224.html
CONTACT:
Douglas Sayles of Biopure Corporation,
+1-617-234-6826, IR@biopure.com
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