CAMBRIDGE, Mass., Nov. 7 /PRNewswire-FirstCall/ -- Biopure Corporation
(Nasdaq: BPUR) announced today that the independent Data and Safety
Monitoring Board (DSMB) for the company's Phase II clinical trial of
Hemopure(R) [hemoglobin glutamer - 250 (bovine)] in trauma patients has
completed its first scheduled interim analysis of blinded study data and
recommended that the trial continue without modification. The DSMB reviewed
mortality and other safety data from the first 21 patients enrolled in this
single-center trial at Johannesburg Hospital Trauma Unit in South Africa.
The 50-patient, single-blind Phase II trial is designed to assess the
safety and tolerability of Hemopure, in a hospital setting, for emergency
treatment of unstable patients who have significant blood loss as a result
of blunt or penetrating trauma. Patients are randomly assigned to receive
either standard therapy resuscitation fluids (crystalloids, colloids and/or
blood) or up to 10 units of Hemopure plus standard therapy. The treatment
period for administering Hemopure is up to four hours from the first
infusion. Patients are monitored until discharged from the hospital and at
28 days post-infusion.
The role of the DSMB is to evaluate data from the ongoing trial to
determine whether there are safety issues that would warrant modification
of the protocol or early termination of the study. The DSMB is independent
of Biopure and is comprised of one biostatistician and three doctors from
the U.S. with relevant expertise in the care of trauma patients, experience
in clinical trials involving traumatic injuries, and no intellectual or
financial conflict of interest. The next DSMB meeting is scheduled to occur
after patient #38 is enrolled and has completed the 28-day follow up visit.
After the trial is completed, the DSMB will meet again to review the data
for all 50 enrolled, evaluable patients and assess the safety of the
product. The trial has enrolled 23 patients to date.
About 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. 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.
Statements in this announcement that are not strictly historical are
forward-looking statements. 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,
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-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 announcement 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/
http://www.prnewswire.com/comp/131224.html /
CONTACT:
Douglas Sayles of Biopure Corporation,
+1-617-234-6826, IR@biopure.com; or Investors: Herb Lanzet of
H.L. Lanzet Inc., +1-212-888-4570, lanzet@aol.com
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