Navigation Links
U.S. Naval Medical Research Center Resubmits IND Application for Proposed 'RESUS' Clinical Trial in Trauma Patients in the Out-of-Hospital Setting
Date:3/23/2009

CAMBRIDGE, Mass., March 23 /PRNewswire-FirstCall/ -- Biopure Corporation (Nasdaq: BPUR) announced today that the U.S. Naval Medical Research Center (NMRC) has submitted to the Food and Drug Administration (FDA) a revised investigational new drug (IND) application to conduct a clinical trial of the company's oxygen therapeutic Hemopure(R) [hemoglobin glutamer - 250 (bovine)] for the pre-hospital treatment of trauma patients. The study is entitled "Restore Effective Survival in Shock" (RESUS). The RESUS trial was first proposed and submitted to the FDA in 2005. The proposed trial was placed on clinical hold at that time. It has been resubmitted repeatedly in response to FDA comments and to address comments made by the FDA Blood Products Advisory Committee at an open meeting held in December 2006. Each subsequent submission was placed on clinical hold.

Under a research agreement with Biopure, the NMRC assumed primary responsibility, subject to funding, for designing, seeking FDA acceptance of and directing a trial for Hemopure's prehospital used in trauma patients with hemorrhagic shock. The NMRC has developed protocols for trials in civilian casualties in the United States and abroad (RESUS) as well as a trial proposed to be conducted in the field, called Operation RESUS (OP RESUS). To date, Congress has appropriated funds for the development of Hemopure for potential use in military and civilian trauma indications and to cover military administrative costs. This funding is being used for trial preparation and for preclinical studies of Hemopure in animal models, including those that mimic military trauma scenarios.

As previously reported, in June 2008 the NMRC submitted and subsequently withdrew an Op RESUS protocol for a Phase 2 clinical trial of Hemopure for resuscitation of operations casualties with severe traumatic hemorrhagic shock, when blood transfusion is not available. The proposed trial hypothesis is that for such casualties Hemopure will improve survival and other clinical parameters, and will be relatively safe and well tolerated, in comparison with "standard fluids." If the trial were permitted to proceed, subjects would sign an informed consent prospectively. The Op RESUS protocol was also revised, resubmitted and placed on clinical hold.

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 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.

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 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 pursue its business, unexpected costs and expenses, delays and adverse determinations by regulatory authorities and unanticipated problems with the product's commercial use, whether or not product related, and the other factors identified under the heading "Risk Factors" in the Company's annual report on Form 10-K/A filed on March 3, 2009, 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©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. U.S. Naval Medical Research Center Resubmits IND Application for Proposed Op RESUS Clinical Trial in Trauma Patients in the Battlefield Setting
2. Harvard Medical School-Partners HealthCare Center for Genetics and Genomics Successfully Completes Evaluation of AutoGenomics 2C9-VKORC1 Panel to Assess Warfarin Sensitivity
3. You May Have a Thyroid Problem and Not Know It - Particularly If Youre Over 60, Says a New Harvard Medical School Report
4. Harvard Medical School-Partners HealthCare Center for Genetics and Genomics Successfully Completes Evaluation of AutoGenomics 2C9-VKORC1 Panel to Assess Warfarin Sensitivity
5. Globus Medical Raises $110 Million in Series E Financing Round
6. Quark Pharmaceuticals Appoints New Chief Medical Officer
7. Boston University Biomedical Engineers Find Chink in Bacterias Armor
8. Rochester Medical Anti-Infection Foley Catheter Demonstrates Effectiveness in Randomized Trial
9. Rockwell Medical Technologies, Inc. Begins Patient Enrollment for its SFP Dose-Ranging Study
10. Flexible Medical Systems Raises $1.2M Seed Investment for Initial Human Trials
11. Cleveland Clinic Summits to Focus on Cardiovascular Medical Innovation
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/26/2016)... SYDNEY , June 26, 2016 One of ... , has announced the formation of a new biotechnology company, Noxopharm ... raise $6m in an IPO and to list on the ASX. ... drug candidate, NOX66, ready to enter a Phase 1 clinical study ... been designed to address one of the biggest problems facing cancer ...
(Date:6/26/2016)... June 27, 2016 Jazz Pharmaceuticals plc (Nasdaq: ... under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as ... Celator Pharmaceuticals, Inc. ("Celator"; Nasdaq: CPXX ) ... Daylight Time). As previously announced on May ... definitive merger agreement under which Jazz Pharmaceuticals has commenced ...
(Date:6/26/2016)... Ontario , June 27, 2016  VMS Rehab ... Company,s Board will take whatever measures required to build ... Company,s stock which is currently listed on the OTC ... Wexler, Company Chairman and CEO, "We are seeing an ... difficult to understand, not only by the Company, but ...
Breaking Medicine Technology:
(Date:6/27/2016)... ... June 27, 2016 , ... ... authorized OSHA Training Institute Education Center headquartered in Northern California, has issued an ... extreme heat at their worksites. Employers with workers exposed to high temperatures ...
(Date:6/27/2016)... ... 27, 2016 , ... "FCPX editors can now reveal their media with growing ... said Christina Austin - CEO of Pixel Film Studios. , ProSlice Color brings ... users can now reveal the media of their split screens with growing colorful panels. ...
(Date:6/27/2016)... ... June 27, 2016 , ... TherapySites, ... its affiliation with Tennessee Counseling Association. This new relationship allows TherapySites ... Tennessee Counseling Association, adding exclusive benefits and promotional offers. , "TCA is extremely ...
(Date:6/27/2016)... ... June 27, 2016 , ... ... announced its strategic partnership with Connance, a healthcare industry leader providing predictive ... proven, proprietary technology combine to provide health systems, hospitals and ambulatory surgical ...
(Date:6/27/2016)... (PRWEB) , ... June 27, 2016 , ... ... cutting edge technology to revolutionize the emergency ambulance transport experience for the millions ... aware of how Uber has disrupted the taxi industry through the use of ...
Breaking Medicine News(10 mins):