CAMBRIDGE, Mass., March 13 /PRNewswire-FirstCall/ -- Biopure Corporation
(Nasdaq: BPUR) announced today that the Food and Drug Administration (FDA) has
notified the Navy of its intention to consult an FDA Advisory Committee within
six months to discuss the Navy's proposed "RESUS" clinical trial of Biopure's
oxygen therapeutic Hemopure(R) [hemoglobin glutamer - 250 (bovine)] for
out-of-hospital treatment of hemorrhagic shock resulting from traumatic
injury. The investigational new drug application (IND) for RESUS that the
Naval Medical Research Center (NMRC) submitted to FDA in June 2005 remains on
clinical hold because of issues related to the predicted risk-benefit profile
of the product under the proposed protocol. FDA has requested additional
information, clarification and comment on completed animal studies, the RESUS
protocol and other aspects of the IND. FDA also requested changes to the
protocol and investigators brochure.
"We continue to believe that the product's risk-benefit profile, as an
emergency pre-hospital treatment until patients can receive blood or other
standard treatment at a hospital, supports allowing RESUS to proceed," said
Biopure Chairman and CEO Zafiris G. Zafirelis. "We are working with NMRC and
its RESUS Advisory Board to further address FDA's concerns so this important
study can ultimately move forward."
Under a research agreement with Biopure, NMRC has primary responsibility
for developing, obtaining FDA acceptance of and conducting the RESUS trial.
As part of this process, NMRC conducted preclinical studies of Hemopure in
animal models of hemorrhagic shock, including an FDA-requested study in
uncontrolled hemorrhage with traumatic brain injury.
NMRC also established a RESUS Advisory Board of military and academic
experts in trauma, emergency medicine, emergency medical services, surgery,
critical care, anesthesiology, hematology, internal medicine, infectious
diseases, bioethics and biostatics. This board has evaluated clinical and
preclinical data on Hemopure, designed the proposed RESUS trial and provided
ongoing program review and consultation.
RESUS (Restore Effective Survival in Shock) is a government-funded study
designed as a single-blinded, multi-center, randomized, controlled, Phase 2b/3
clinical trial. The objective is to assess the safety and efficacy of
Hemopure, as compared with standard treatment, in reducing morbidity and
mortality in severely injured patients experiencing hemorrhagic shock (acute
blood loss) in the out-of-hospital setting, where blood is not available for
transfusion.
In the proposed study, 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. All patients would receive standard
therapy (blood transfusion if indicated) upon arrival at the hospital.
Because patients would be unconscious or traumatized, the trial design
provides an exception from informed consent and a community consultation and
disclosure process, as defined in FDA regulation 21 CFR 50.24.
In order for RESUS to proceed, FDA must lift the clinical hold and the
Department of Defense and the internal review boards of participating
hospitals in the communities where the study would take place must provide
final authorization.
Out-of-Hospital Fluid Resuscitation
Traumatic injuries may cause massive bleeding resulting in rapid loss of
oxygen-carrying capacity. The current standard of care for acute hemorrhage
outside of the hospital is fluid resuscitation with crystalloids or colloids,
which replace lost blood volume but do not carry oxygen. These resuscitative
fluids may not sufficiently extend survival in trauma casualties, particularly
when evacuation to a hospital is delayed or prolonged. Blood transfusion
provides both volume and oxygen-carrying support, but is rarely practical in
the field because stored blood requires refrigeration, is type specific and
has a limited shelf life.
If safety and effectiveness can be demonstrated and regulatory approval
obtained, Biopure believes that the compatibility with all blood types,
long-term stability without refrigeration (3 years at 35.6 to 86 degrees
Fahrenheit, 18 months at 104 degrees Fahrenheit) and other properties of
Hemopure could allow it to be stockpiled, positioned abroad, and carried or
stored in remote locations for use as an oxygen-carrying resuscitative fluid
when blood is not available. These attributes may make it well suited for use
on the battlefield, in ambulances, and in the Strategic National Stockpile.
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 product has not been
approved for sale in other countries. Biopure plans to apply in Europe, in
mid 2006, for approval of an acute anemia indication in orthopedic surgery
patients. The company is developing Hemopure for a potential indication in
cardiovascular ischemia, in addition to supporting the U.S. Naval Medical
Research Center's government-funded development of a potential out-of-hospital
trauma indication. To date, Hemopure has been administered to over 350
patients post approval in South Africa and to over 800 human subjects in
clinical trials, including two ongoing trials in Europe and South Africa. The
company'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. To date, Biopure has sold approximately 173,000
units of Oxyglobin, which have been used to treat an estimated 90,000 animals.
Statements in this press release that are not strictly historical are
forward-looking statements, including any that might imply that the proposed
RESUS trauma trial will receive authorization to proceed. 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, delays and 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, and delays
in or 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 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-K filed on January 17, 2006, 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 Herb Lanzet (Investors)
Biopure Corporation H.L. Lanzet Inc.
(617) 234-6826 (212) 888-4570
IR@biopure.com lanzet@aol.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; Investors - Herb Lanzet of H.L.
Lanzet Inc. for Biopure Corporation, +1-212-888-4570,
lanzet@aol.com
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