Myocardial salvage, erythropoeitic effect and quality of life indications
to be pursued
CAMBRIDGE, Mass., Oct. 15 /PRNewswire-FirstCall/ -- Biopure Corporation
(Nasdaq: BPURD) today announced it is undertaking a revamped clinical
development program and expects to further its ischemia development in
heart attack patients. Biopure expects to move on several fronts,
emphasizing clinical development in Europe.
The company has decided to leverage into new indications the body of
research it has amassed in preclinical and clinical studies involving
anemia. The company has also identified the next step in its ischemia
clinical program.
New Clinical Trials
Three phase 2 clinical trials are proposed and being designed for 2008:
one in heart attack patients, one to address anemia in chemotherapy
patients instead of or in addition to erythropoietin stimulating agents
(ESAs), and one to investigate possible improvement of quality of life in
the terminally ill.
Erythropoietic Agent Trial
The ESA study, to be designed, would examine whether Hemopure might be
useful as an alternative to or in conjunction with ESAs, such as Aranesp or
Procrit, which are hormones that enhance the production of red blood cells.
Recently the FDA has required a label warning about the use of ESAs, and
reported sales of those products have declined. The proposed Hemopure study
would seek safety and preliminary efficacy information using Hemopure,
which is not a hormone, for erythropoietic effect. Biopure has observed
evidence in previous clinical trials that Hemopure may have such an effect.
This would be its first clinical trial to test the hypothesis
In a Phase II multicenter, double-blind, post-cardiopulmonary bypass
clinical trial completed by Biopure in 1997, which compared the
post-operative use of Hemopure to donated red blood cells in cardiac
surgery, the hematocrit, or packed red blood cell volume as a percentage of
total blood volume, was similar for both the Hemopure-infused and the
control patients on the sixth day following surgery. Both groups maintained
this similarity when measured again at a follow-up visit 28 days after
surgery. A red blood cell transfusion infuses red blood cells into the
patient's blood stream. An infusion of Hemopure does not. Consequently, the
similarity of red blood cell volume in both groups of patients suggests
that Hemopure may promote the regeneration of red blood cells. The use of
Hemopure as an erythropoietic agent is also supported by at least one
Biopure preclinical study.
Palliative Care Trial
The second proposed study would be an open-label (non-randomized)
compassionate use, Phase 2 study expected to be coordinated by the Duke
Cancer Care Research Program. Participants are expected to be patients with
advanced life-limiting illness. Hemopure would be evaluated on its oxygen
carrying capacity to increase perfusion and improve the quality of life in
this patient population, which is typically ESA-resistant. The study would
measure, using well established methods, both quantitative and qualitative
outcomes. Anemia is a significant but understudied problem in terminally
ill patients. In a recent study of 105 palliative care patients, of whom 95
had advanced cancer, anemia was found in 77% of men and 68.2% of women.
Heart Attack
The company is preparing a Phase 2, multicenter double-blind study to
evaluate Hemopure when used as an adjunctive therapy for ST-segment
elevation myocardial infarction, or a major heart attack. The hypothesis to
be tested is that Hemopure might have "cardio-protective effects" in this
patient population by reducing the extent of the injury to the heart.
Trauma
The company continues to support the efforts of the U.S. Navy, which
intends to conduct a phase 2 pre-hospital clinical trial in the United
States in trauma patients. The trial, called "Restore Effective SUrvival in
Shock," or RESUS, has been under consideration by the FDA since 2005.
Issues concerning the FDA perception of Hemopure and other hemoglobin-based
oxygen carriers and the aspect of the trial that requires a waiver of
informed consent by patients continue to delay this trial. Nevertheless,
the RESUS program is continuing with a view to overcoming all issues.
Surgery and United Kingdom Marketing Authorization
As previously reported, the company submitted an application to the
Medicines and Healthcare products Regulatory Authority (MHRA) in the U.K.,
and received a provisional response in December 2006. The company met with
the MHRA in September to review its proposed final responses to the agency
questions. The company anticipates submitting its response, incorporating
suggestions made at that meeting, at the end of this month. The company is
hopeful of a positive outcome of the MHRA review. There is no time schedule
in the law applicable to this review, but the historic typical response
time is four to six months. The indication sought is orthopedic surgery
where blood is not an option.
All trial designs described are subject to further expert input and to
changes that could result from hospital ethics committee reviews when
protocols are submitted, as well as applicable governmental agency reviews.
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 several
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 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 186,000 units
of Oxyglobin, which have been used to treat an estimated 100,000 animals.
Statements in this release that are not strictly historical are
forward- looking statements, including those statements implying that any
planned clinical trial will be carried out or that study results will be as
desired, statements related to the timing and response of the MHRA review
and any statements that might imply that Hemopure may receive marketing
approval in additional jurisdictions or for additional indications. 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 these initiatives, 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 or unpredictable outcomes of 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 14, 2007, 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.
The content of this 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: Todd Wood Herb Lanzet (Investors)
Biopure Corporation H.L. Lanzet Inc.
(617) 234-6576 (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:
Todd Wood of Biopure Corporation,
+1-617-234-6576, IR@biopure.com; or Investors, Herb Lanzet of
H.L. Lanzet Inc., +1-212-888-4570, lanzet@aol.com
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