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
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
Biopure Corporation
(617) 234-6826
IR@biopure.com
SOURCE Biopure Corporation
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Related links:
http://www.biopure.com
http://www.prnewswire.com/comp/131224.html/
CONTACT:
Tiana Gorham of Biopure Corporation,
+1-617-234-6826, IR@biopure.com
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