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:2/23/2017)... MA (PRWEB) , ... February 23, 2017 , ... ... and Department of Justice jointly issued a letter to withdraw previous ... accordance with their gender identity. The guidance issued in May 2016 by the ...
(Date:2/23/2017)... ... 23, 2017 , ... Rare Disease Report®, which is the ... Rare Disease Day events, hosted by the Rare Disease Legislative Advocates (RDLA) on ... weekly e-newsletter and quarterly publication, will be conducting interviews with patients and advocates ...
(Date:2/23/2017)... CA (PRWEB) , ... February 23, 2017 , ... Hamlin ... to announce that they are sponsoring a raffle. Throughout the month of February, patients ... will receive a gift card for a dinner for two at the Cheesecake Factory. ...
(Date:2/23/2017)... ... February 23, 2017 , ... On April 13, 2017, ... on “Doping in Sport: How the Culture Might Change,” in conjunction ... The symposium will be held at Pepperdine University in Malibu, California. , Sir ...
(Date:2/23/2017)... ... February 23, 2017 , ... ERT, a global ... announced that Premier Research, a leading clinical development service provider, has selected ERT’s ... increasingly complex, due in part to an array of circumstances including the use ...
Breaking Medicine News(10 mins):
(Date:2/23/2017)... DUBLIN , Feb 23, 2017 ... Research and Markets has announced ... - Industry Forecast to 2025" report to their offering. ... CAGR of around 1.8% over the next decade to reach approximately $12.8 ... market estimates and forecasts for all the given segments on global as ...
(Date:2/23/2017)... MARIETTA, Ga., Feb. 23, 2017  MiMedx Group, Inc. ... amniotic tissue and patent-protected processes to develop and market ... Orthopedic, Spine, Sports Medicine, Ophthalmic, and Dental sectors of ... quarter and full year ended December 31, 2016. ... Revenue is a 31% increase over full year ...
(Date:2/23/2017)... DUBLIN , Feb 23, 2017 Research ... Prosthetic Devices Market Analysis & Trends - Industry Forecast to 2025" ... ... to grow at a CAGR of around 9.2% over the next ... industry report analyzes the market estimates and forecasts for all the ...
Breaking Medicine Technology: