CAMBRIDGE, Mass., July 7 /PRNewswire-FirstCall/ -- Biopure Corporation
(Nasdaq: BPUR) announced today that it has had discussions with the Food
and Drug Administration (FDA) on identifying an acceptable patient
population for a new clinical trial of Hemopure(R) [hemoglobin glutamer -
250 (bovine)], or HBOC-201. Biopure has proposed to study use of Hemopure
in patients suffering from Acute Myelogenous Leukemia (AML) who refuse
transfusion with blood components. Currently, AML patients who do not
accept blood transfusions are unable to undergo potentially life-saving
induction chemotherapy because of the profound anemia the chemotherapy
causes. Biopure is preparing to submit a protocol for such patients for
consideration by FDA. Patients would give informed consent before being
enrolled in this study. An effective treatment for this patient population
represents an unmet medical need because of an expected 100% mortality
within 6 months in the absence of induction chemotherapy. The purpose of
the study would be to assess the efficacy of Hemopure in providing an
oxygen carrier in lieu of transfusion with red blood cells, as an adjunct
to other special procedures, following induction chemotherapy for AML. A
successful trial in this population could be pivotal to establish an
intended use for Hemopure in this clinical setting.
"We are very excited at the possibility of initiating a new clinical
trial with Hemopure in the U.S. If this trial provides convincing evidence
of benefit in this high mortality population, it has the potential to
become a pivotal trial for Hemopure's use as an adjunct to AML induction
chemotherapy when transfusion with blood components is refused by the
patient," said Zafiris G. Zafirelis, Biopure CEO and President. "By serving
as an oxygen delivery bridge following chemotherapy-induced suppression of
red blood cell count, use of Hemopure, as part of a bloodless treatment
regimen, may potentially reduce mortality in these patients, who currently
have no hope," he added.
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 Company is
developing Hemopure for other indications and 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. Biopure has
sold approximately 200,000 units of Oxyglobin since its launch.
Statements in this release that are not strictly historical are
forward- looking statements, including any statements implying that any
clinical trial will be initiated and/or carried out to completion or that
study results will be as desired, and any statements that might imply that
Hemopure may receive marketing approval in any jurisdictions other than
South Africa or for a trauma indication anywhere. 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, the company's ability to satisfactorily address the
issues raised in the MHRA correspondence or additional issues raised at a
later date, unexpected costs and expenses, delays and adverse
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, delays in clinical
trials, and the other factors identified under the heading "Risk Factors"
in the Company's quarterly report on Form 10-Q filed on June 16, 2008, as
amended on June 18, 2008, 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: Tiana Gorham
Biopure Corporation
(617) 234-6826
IR@biopure.com
SOURCE Biopure Corporation
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Related links:
http://www.biopure.com
http://www.prnewswire.com/comp/131224.html/
CONTACT:
Tiana Gorham of Biopure Corporation,
+1-617-234-6826, IR@biopure.com
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