U.S. Naval Medical Research Center Proposed 'RESUS' Clinical Trial in Trauma Patients Remains on FDA Hold
18 5월 2009 - 9:00PM
PR Newswire (US)
CAMBRIDGE, Mass., May 18 /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 oxygen therapeutic Hemopure(R) [hemoglobin glutamer --
250 (bovine)] under a proposed protocol submitted to the FDA in
March 2009. As previously announced, the study, "Restore Effective
Survival in Shock" (RESUS) was first proposed and submitted to the
FDA in 2005. The proposed trial was placed on clinical hold at that
time. It has been resubmitted repeatedly in response to FDA
comments and to address comments made by the FDA Blood Products
Advisory Committee at an open meeting held in December 2006. Each
subsequent submission, including the most recent, was placed on
clinical hold. 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 used in trauma patients with hemorrhagic shock. The
NMRC has also developed and submitted a protocol for a trial
proposed to be conducted in the field, called Operation RESUS (OP
RESUS). 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 fluids." Op RESUS is also on clinical hold, and the
company does not expect the FDA to permit RESUS or OP RESUS to
proceed in the foreseeable future. The company expects the NMRC to
seek FDA approval for a clinical trial of Hemopure with a
concomitant drug to address vasoactivity, which occurs with the use
of Hemopure alone. The NMRC and the FDA are in discussions
concerning such a trial, and the NMRC is conducting preclinical
studies recommended by the FDA to prepare for such a trial. The
NMRC continues to buy Hemopure for this testing. 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.
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
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.
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 and viability, unexpected costs
and expenses, delays and adverse determinations by regulatory
authorities and unanticipated problems with the product's
commercial use, whether or not product related, and the other
factors identified under the heading "Risk Factors" in the
Company's annual report on Form 10-K/A filed on March 3, 2009,
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: Zafiris Zafirelis
Biopure Corporation (617) 234-6500 DATASOURCE: Biopure Corporation
CONTACT: Zafiris Zafirelis of Biopure Corporation, +1-617-234-6500,
Web Site: http://www.biopure.com/
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