Panel on Hemoglobin-Based Oxygen Carriers Indicates Support for Continued
Investigational Use Where Blood Is Not an Option
CAMBRIDGE, Mass., May 7 /PRNewswire-FirstCall/ -- Biopure Corporation
(Nasdaq: BPUR) announced today that the Company's strategy to pursue
indications for its product Hemopure(R) [hemoglobin glutamer-250 (bovine)],
or HBOC-201, when blood is not an option was reinforced by the National
Institutes of Health/Food and Drug Administration (NIH/FDA) recent
workshop. The workshop, entitled "The Safety of Hemoglobin-based Oxygen
Carriers," took place on April 29 and 30, 2008 in Bethesda, Maryland. The
purpose of a public workshop is to discuss issues in featured presentations
and roundtable discussions led by experts from academic institutions,
government, and industry. No actions are typically taken at workshops. The
transcript is expected to be available on the FDA website by late May 2008.
"A number of participants in this important workshop recognize the
therapeutic potential that Hemoglobin-based Oxygen Carriers (HBOCs) offer
to patients who may not have the option of receiving packed red blood
cells," said Biopure Chairman and CEO Zafiris G. Zafirelis. "The company's
initial strategy with Hemopure was to develop indications in the treatment
of adult surgical patients who are acutely anemic, as in South Africa,
where Hemopure has market authorization and is being used clinically. We
also believe there are excellent applications for its use where blood is
not indicated, and in out-of-hospital treatment of trauma patients in
hemorrhagic shock, where red blood cells are not available."
Biopure Vice President of Medical Affairs Dr. A. Gerson Greenburg
delivered the company's presentation, including a platform for moving
forward with its Hemopure product. Dr Greenburg noted first, that future
trials should exclude competition with packed red blood cells and target
use where blood is not an option or not available. Furthermore, the safety
profile of each member of the class of HBOCs should be evaluated
individually. He also presented results of analysis of the company's
surgical orthopedic trial, HEM-0115, which will be published in the Journal
of Trauma. Dr. Greenburg's presentation is available on Biopure's website.
The day before the workshop, the Journal of the American Medical
Association (JAMA) published a meta-analysis of HBOCs as a class. At the
workshop, one of the article's authors presented the findings, which raised
questions about safety signals in the absence of clinical benefit shown in
some of the trials in the meta-analysis. Dr. Greenburg stated that the
different compositions of the HBOCs considered, including some no longer in
development, invoke a principle of heterogeneity that would argue against
any comparisons made from combining data.
Experts presenting at the workshop repeatedly opined that FDA should
permit carefully designed randomized controlled clinical trials of the
current generation of HBOCs in patients with life-threatening anemia who do
not have the option of a blood transfusion. Dr. Colin MacKenzie of the
University of Maryland chaired a symposium prior to the workshop during
which clinicians discussed their experience with the clinical use of
Hemopure in South Africa and in compassionate use patients, approved on an
individual basis by the FDA. This symposium is available at the University
of Maryland website at http://hfrp.umm.edu/cucases .
Dr. Demetrios Demetriades, Professor of Surgery and Director of Trauma
and Surgical Intensive Care Unit, University of Southern California School
of Medicine, suggested that the products might be made available for
compassionate use in patients such as Jehovah's Witnesses, for whom blood
transfusions are unacceptable. He conceded that there was a major unmet
need for these products and that he felt "we are not there yet." Dr. Gus
Vlahakes, Professor of Surgery, Harvard Medical School, and Chief of
Cardiac Surgery , Massachusetts General Hospital and Co-Director of the
Massachusetts General Hospital Heart Center, stated that, theoretically,
HBOCs may have significant benefit in clinical settings where blood is not
available, specifically in trauma and cardiac surgery.
Daniel Freilich, MD, CDR, MC, USN, and head of the hematomimetics
program at the Naval Medical Research Center, presented his opinion that an
optimization of study design and practice guidelines would enable clinical
evaluation of the current generation of HBOCs with reasonable risk. To
maximize the potential for benefit and minimize potential for harm, he
suggested targeting a population younger than 70 who were seriously wounded
and would most likely die in situations where blood is not available, such
as on the battlefield. The Naval Medical Research Center has been
attempting to conduct a clinical trial using Hemopure in out-of-hospital
trauma patients.
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 in 1998.
Statements in this press release that are not strictly historical are
forward-looking statements, including any statements related to the
company's platform for moving forward with Hemopure, future clinical
applications of Hemopure, the company's strategy for commercialization in
South Africa, and statements implying future clinical studies and the
availability of HBOC products. 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,
possible delays related to clinical trials, determinations by the FDA, and
unpredictable outcomes of preclinical and 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 March 17, 2008, 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.
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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