Previously Proposed 1100-Patient Phase IIb/III Trial to be Adapted as
Smaller, Phase II Trial
CAMBRIDGE, Mass., Dec. 20 /PRNewswire-FirstCall/ -- Biopure Corporation
(Nasdaq: BPUR) announced today that the Navy is in discussions with the
Food and Drug Administration (FDA) regarding potential protocol revisions
to its previously proposed RESUS Phase IIb/III pre-hospital trauma trial of
Hemopure(R) [hemoglobin glutamer - 250 (bovine)] that could enable RESUS to
proceed as a smaller, Phase II trial, subject to FDA approval. The Navy and
the FDA communicated following last week's meeting of the FDA Blood
Products Advisory Committee (BPAC), at which BPAC members discussed
possible protocol modifications.
As previously announced, the BPAC voted 11 to 8, with one abstention,
against proceeding with the proposed 1100-patient, RESUS Phase IIb/III
trial. Committee members suggested that, in view of the product's potential
benefit in this patient population, RESUS be modified as a pre-hospital
Phase II study designed to provide safety and efficacy data in a few
hundred patients.
"The BPAC meeting was very productive in that it identified a path
forward for the study of Hemopure as an emergency pre-hospital treatment
until patients can receive blood or other standard treatment at a
hospital," said Biopure President and CEO Zafiris G. Zafirelis. "RESUS is
designed to assess whether Hemopure can improve survival in trauma patients
who have a high risk of death, possibly greater than fifty percent, under
the current standard of care."
Over the next several weeks, Biopure plans to work with the Naval
Medical Research Center (NMRC), which is sponsoring RESUS, to revise the
study protocol and investigational new drug (IND) application for
resubmission to the FDA and, subsequently, to the NMRC's own institutional
review board. The trial will be modified as a Phase II study comprising a
few hundred patients. Other changes to consider, based on the BPAC
discussion, include adjusting the trauma score, age inclusion criteria, and
pre-hospital transportation time. The BPAC also discussed incorporating
some military operational aspect into the Navy's trauma development program
for Hemopure.
RESUS (Restore Effective Survival in Shock)
RESUS is a government-funded study designed as a single-blinded, multi-
center, randomized, controlled clinical trial. The objective is to evaluate
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. 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 would provide 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, the FDA must lift its clinical hold and
the Department of Defense and the institutional 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. Biopure has applied
in the United Kingdom for regulatory approval of a proposed orthopedic
surgical anemia indication. The company is developing Hemopure for a
potential indication in cardiovascular ischemia, in addition to 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 by the U.S. Food and Drug Administration and
the European Commission, is indicated for the treatment of anemia in dogs.
Biopure has sold approximately 180,000 units of Oxyglobin, which have been
used to treat an estimated 98,000 animals.
Statements in this press release that are not strictly historical are
forward-looking statements, including any statements regarding the expected
size of the next clinical trial or future actions by the NMRC and any
statements that might imply that the proposed RESUS trauma trial will
receive authorization to proceed. 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, unexpected costs
and expenses, delays and determinations by regulatory authorities, 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-Q filed on September 11, 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
Biopure Corporation
(617) 234-6826
IR@biopure.com
Herb Lanzet (Investors)
H.L. Lanzet Inc.
(212) 888-4570
lanzet@aol.com
SOURCE Biopure Corporation
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Related links:
http://www.biopure.com
http://www.sec.gov
http://www.prnewswire.com/comp/131224.html/
CONTACT:
Douglas Sayles of Biopure Corporation,
+1-617-234-6826, IR@biopure.com, or, Herb Lanzet of H.L. Lanzet
Inc, Investors, +1-212-888-4570, lanzet@aol.com
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