Biopure Announces Expanded Clinical Program To Target Anemia
15 10월 2007 - 9:02PM
PR Newswire (US)
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 DATASOURCE: Biopure Corporation
CONTACT: Todd Wood of Biopure Corporation, +1-617-234-6576, ; or
Investors, Herb Lanzet of H.L. Lanzet Inc., +1-212-888-4570, Web
site: http://www.biopure.com/ Company News On-Call:
http://www.prnewswire.com/comp/131224.html
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