Biopure Submits IND Application for Proposed Clinical Trial in Patients with Acute Myeloid Leukemia
18 December 2008 - 12:35AM
PR Newswire (US)
CAMBRIDGE, Mass., Dec. 17 /PRNewswire-FirstCall/ -- Biopure
Corporation (NASDAQ:BPUR) announced today that it has submitted to
the Food and Drug Administration (FDA) an investigational new drug
(IND) application to conduct a pilot phase 2 clinical trial of the
company's oxygen therapeutic Hemopure(R) [hemoglobin glutamer - 250
(bovine)]. In the proposed trial Hemopure would be studied for use
in the treatment of life-threatening anemia secondary to induction
chemotherapy in patients with acute myeloid leukemia (AML) who
refuse red blood cell transfusion. As previously reported, the
company met with the FDA in July 2008 to discuss an acceptable
patient population for a new clinical trial. At that time the
company proposed a trial in AML patients who will not accept blood
transfusions and consequently are unable to undergo potentially
life-saving induction chemotherapy because of the profound anemia
the chemotherapy causes. The purpose of the proposed study would be
to study the efficacy of Hemopure in delivering oxygen in the
absence of red blood cell transfusion. An effective treatment for
this patient population represents an unmet medical need because of
an expected 100% mortality within several months without induction
chemotherapy. 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 developing Hemopure 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
more than 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 proposed trial will be permitted to proceed by the FDA, that if
a trial is permitted to proceed funding for the trial will be
available 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
resume full operations and remain in business, 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 September 15,
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: Rob Skiba Biopure Corporation (617)
234-6500 DATASOURCE: Biopure Corporation CONTACT: Rob Skiba of
Biopure Corporation, +1-617-234-6500,
Copyright
Biopure (MM) (NASDAQ:BPUR)
Historical Stock Chart
From May 2024 to Jun 2024
Biopure (MM) (NASDAQ:BPUR)
Historical Stock Chart
From Jun 2023 to Jun 2024
Real-Time news about Biopure (MM) (NASDAQ): 0 recent articles
More Biopure (MM) News Articles