U.S. Naval Medical Research Center Resubmits IND Application for Proposed 'RESUS' Clinical Trial in Trauma Patients in the Out-o
March 23 2009 - 7:30AM
PR Newswire (US)
CAMBRIDGE, Mass., March 23 /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 treatment of trauma patients. The study is
entitled "Restore Effective Survival in Shock" (RESUS). The RESUS
trial 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 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 developed protocols for trials in
civilian casualties in the United States and abroad (RESUS) as well
as a trial proposed to be conducted in the field, called Operation
RESUS (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. 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 fluids." If the trial were
permitted to proceed, subjects would sign an informed consent
prospectively. The Op RESUS protocol was also revised, resubmitted
and placed on clinical hold. 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, 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 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: Rob Skiba Biopure
Corporation (617) 234-6500 DATASOURCE: Biopure Corporation CONTACT:
Rob Skiba of Biopure Corporation, +1-617-234-6500,
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