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Biopure Seeks Compassionate Use Protocol For Treatment Of Acute Anemia
Biopure Corporation
(Nasdaq: BPUR) announced that the company submitted a draft clinical
study protocol to the FDA for compassionate use of the investigational
product Hemopure (HBOC-201) in the United States. The proposed open label
study would make Hemopure available to patients for the treatment of life
threatening or potentially life threatening anemia on a compassionate use
basis where blood transfusion is not an option.
The product has been available for compassionate use since December
2006. Under the existing program the company evaluates individual requests
from treating physicians for specific patients. If the patient is deemed an
appropriate candidate for treatment, the FDA is contacted and a single
patient IND is requested. To date the FDA has authorized shipment of
Hemopure for 20 patients. Of the treated patients, four were experiencing
severe anemia secondary to the management and treatment of leukemia and
lymphoma. The balance of the compassionate use cases were for the treatment
of blood loss resulting from surgical complications or trauma. The
remaining patients who were not treated stabilized at the site by the time
the drug was received.
The draft protocol outlines general eligibility criteria that include
the following:
-- Severe, life threatening, or potentially life threatening anemia
-- Blood transfusion is not feasible
-- All alternative treatment options have been exhausted
-- Adult male or female - 18 years of age, or child with anemia secondary
to severe burns
The safety, efficacy and pharmacology of Hemopure have been studied in
22 completed clinical trials. An additional four trials are ongoing. The
clinical program was initially designed to evaluate Hemopure as a
replacement for red blood cell transfusions, by providing an Oxygen
Bridge(TM) in the setting of acute surgical anemia. More than 800 subjects
have received HBOC- 201 and dosing ranged from 25g to 1230g of HBOC-201
administered over a period of up to eighteen days.
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 a
potential indication in cardiovascular ischemia, in addition to 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 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 the
FDA will approve the draft study protocol for the use of Hemopure in the
U.S. in certain life-threatening situations, the patients eligible for any
such study, 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, 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, and
delays in or unpredictable outcomes of clinical trials, and the 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.
Biopure Corporation
http://www.biopure.com
Biopure cautã compasiune Utilizaþi Protocolul pentru tratamentul acutã Anemia - Biopure Seeks Compassionate Use Protocol For Treatment Of Acute Anemia - articole medicale engleza - startsanatate