Navigation Links
Biopure Submits IND Application for Proposed Clinical Trial in Patients with Acute Myeloid Leukemia
Date:12/17/2008

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
             IR@biopure.com


'/>"/>
SOURCE Biopure Corporation
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. Biopure Sues National Institutes of Health Official
2. Agency Takes Adverse Decision to Biopures Product Registration in South Africa
3. Biopure Receives Extension of Time to Regain NASDAQ Listing Compliance
4. Biopure Reaffirms Strategy Following Recent NIH/FDA Workshop
5. Biopure Receives Comment Letter From U.K. Regulatory Body on Marketing Application for Hemopure(R)
6. Biopure Announces 2007 Fourth Quarter and Year-End Financial Results
7. Four Abstracts by Biopure and Collaborating Scientists Accepted for Annual Meeting of American Society for Clinical Pharmacology and Therapeutics
8. Biopure Announces Closing of $14.9 Million Financing
9. Biopures Stock Symbol Reverts to BPUR
10. Biopure Announces Reverse Stock Split
11. ViroPharma Submits Supplemental Biologics License Application for Cinryze(TM) to Treat Acute Attacks of Hereditary Angioedema
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/5/2016)... Salt Lake City, UT (PRWEB) , ... February 05, 2016 , ... ... Activz Whole-Food Nutrition , announced that the much-anticipated feature with author Jahnavi Foster, ... Really Cool Humans Amateur TV Network. , Each week, on his weekly Whole-Food Warrior ...
(Date:2/5/2016)... ... February 05, 2016 , ... ... addition of micro-needling services in their Napa Valley office. The technique utilizes the ... Surgery Associates, Dr. Canales and Dr. Furnas, are part of only a select ...
(Date:2/5/2016)... Miami, Florida (PRWEB) , ... February 05, 2016 ... ... largest non-profit organization devoted exclusively to funding innovative lymphoma research and serving the ... services – is poised to once again host, Swirl, A Wine Tasting Event ...
(Date:2/5/2016)... ... February 05, 2016 , ... Regular gym users know the ... to wait longer to access the treadmills. It’s a predictable trend. After the excesses ... weight and get in shape by joining gyms, starting new walking or running routines, ...
(Date:2/5/2016)... ... , ... At its annual meeting held last week, the American Parkinson Disease ... of Directors. Mr. McDermott succeeds former APDA Chairman, Fred Greene. , "We are pleased ... APDA President and CEO. “Pat has tirelessly served APDA since 2001 when he was ...
Breaking Medicine News(10 mins):
(Date:2/4/2016)... , Feb. 4, 2016  Edwards Lifesciences Corporation ... innovations for structural heart disease and critical care monitoring, ... share repurchase (ASR) agreement with Morgan Stanley & Co. ... This repurchase is part of the Company,s previously authorized ... Company,s common stock.  --> ...
(Date:2/4/2016)... , Feb. 4, 2016   Bernstein Liebhard LLP ... filed in the United States District Court for the District ... class (the "Class") consisting of all persons or entities who ... "Company") (NASDAQ: INSY ) from March 3, 2015 through ... and certain of its officers with violations of the Securities ...
(Date:2/4/2016)... N.J. , Feb. 4, 2016  Montoya Love ... Professional in the field of Pharmaceuticals. Montoya is the ... Manufacturing ... supplies, Becton Dickinson provides healthcare institutions, clinical ... equipment throughout fifty countries across the globe. ...
Breaking Medicine Technology: