U.S. Navy Requested Operations Trial on FDA Hold
31 12월 2008 - 7:00AM
PR Newswire (US)
CAMBRIDGE, Mass., Dec. 30 /PRNewswire-FirstCall/ -- Biopure
Corporation (NASDAQ:BPUR) announced today that the Food and Drug
Administration has advised the U.S. Naval Medical Research Center
("NMRC") by letter that it may not initiate a clinical trial of
Biopure's product Hemopure [hemoglobin glutamer - 250 (bovine)],
under a proposed protocol submitted to the FDA on November 21,
2008. As previously announced, the Navy had filed a protocol for a
proposed trial for the resuscitation of operational casualties with
severe hemorrhagic shock without availability of blood transfusions
("Op RESUS"). While the FDA letter acknowledges that the proposed
trial addresses some of FDA's concerns previously communicated, it
gives three regulatory bases for the hold: safety of subjects,
protocol design deficient to meet its stated objectives; and the
content of the investigator brochure (a summary of information for
those carrying out the trial) and related items. Concerning safety,
the FDA hold letter refers to the risk of exacerbation of bleeding
resulting from product infusion and the "adverse event profile of
[Hemopure]." However, the letter refers in particular to the
results of three previous trauma trials with adverse mortality
rates, none of which was a Hemopure trial and one of which,
according to the FDA, did not involve a hemoglobin based oxygen
carrier. According to the FDA, based on these trials with other
products, it cannot presently approve IND protocols with agents
that may raise blood pressure in acute hemorrhagic shock. The
letter requests a "Clinical Hold Complete Response." The Company
does not know how the NMRC will proceed. 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 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 more than 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 the Company or the U.S. Navy will be able to proceed with any
clinical trial of Hemopure. 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, delays and adverse
determinations by the FDA and other regulatory authorities,
unanticipated problems with the product's commercial use, whether
or not product related, 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 DATASOURCE: Biopure Corporation CONTACT: Rob Skiba of
Biopure Corporation, +1-617-234-6500,
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