Navigation Links
U.S. Navy Submits Protocol for Field Trauma Trial of Hemopure(R)
Date:6/18/2008

CAMBRIDGE, Mass., June 18 /PRNewswire-FirstCall/ -- Biopure Corporation (Nasdaq: BPUR) announced today that the U.S. Naval Medical Research Center (NMRC) has submitted a new protocol for review by the Food and Drug Administration (FDA) for a Phase 2 clinical trial of Hemopure(R) [hemoglobin glutamer - 250 (bovine)], or HBOC-201, for resuscitation of operational casualties with severe traumatic hemorrhagic shock without availability of blood transfusions. The proposed trial hypotheses 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 fluid." Subjects will sign an informed consent prospectively. The study is entitled "Operational Restore Effective Survival in Shock (Op RESUS).

Op RESUS is designed as a single-blinded, randomized and controlled trial with up to 340 evaluable subjects, including operational military and civilian personnel (Department of Defense health system eligible). The primary aim of the study is to compare the 28-day relative rate of death in patients receiving Hemopure versus the group of patients receiving the "standard fluid" for resuscitation (Hextend). Secondary and tertiary outcome measures are also defined. All subjects would receive blood transfusions, when indicated, upon availability.

A successful completion, if attained, of Op RESUS safety primary objectives is expected to support an application to the FDA for allowance to conduct a definitive Phase 3 trial and have potential to improve survival of hemorrhagic shock casualties.

Under a research agreement with Biopure, the NMRC has had primary responsibility for designing, seeking FDA acceptance of and directing a pivotal trauma trial. In carrying out that agreement, the Navy designed and submitted to the FDA a proposed phase 2/3 trial entitled "Restore Effective Survival in Shock" (RESUS). That trial would have been conducted prehospital in civilian trauma patients. The trial was placed on clinical hold by the FDA and continues to be on hold following changes intended to address FDA comments. The newly filed protocol, by incorporating informed consent, is intended to remove requirements attendant to waiver of informed consent. To date, Congress has appropriated a total of $24.2 million for the development of Hemopure.

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. The Company is developing Hemopure for 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 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 approximately 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 clinical trial will be initiated and/or carried out to completion or that study results will be as desired, and any statements that might imply that Hemopure may receive marketing approval in any jurisdictions other than South Africa or for a trauma indication anywhere. 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, the company's ability to satisfactorily address the issues raised in the MHRA correspondence or additional issues raised at a later date, 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 June 16, 2008, as amended on June 18, 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: Tiana Gorham

Biopure Corporation

(617) 234-6826

IR@biopure.com


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

Related medicine technology :

1. BioMarin Partner AnGes MG, Inc. Submits BLA to Japanese Ministry of Health
2. Peregrine Pharmaceuticals Submits Clinical Protocol to Initiate Bavituximab Phase II Trial in Patients With Metastatic Breast Cancer
3. Vanda Pharmaceuticals Submits Iloperidone New Drug Application
4. Peregrine Pharmaceuticals Submits Clinical Protocol for New Phase II Trial of Bavituximab in Patients With Metastatic Breast Cancer
5. Roche Submits Application for FDA Approval of ACTEMRA(R) for the Treatment of Rheumatoid Arthritis
6. AstraZeneca Submits sNDAs for SEROQUEL XR(TM) for the Treatment of Bipolar Mania and Bipolar Depression
7. Takeda Submits New Drug Application for Alogliptin (SYR-322) in the U.S.
8. Pharmion Submits European Marketing Authorization Application (MAA) for Vidaza(R) in Patients with Higher-Risk Myelodysplastic Syndromes (MDS)
9. Gen-Probe Submits U.S. Regulatory Application for Additional Approval of PROCLEIX(R) ULTRIO(R) Blood Screening Assay
10. Cell Therapeutics, Inc. (CTI) Submits European Marketing Authorization Application for XYOTAX(TM)
11. CSL Behring Submits BLA Requesting Approval of C1-Esterase Inhibitor for the Treatment of Hereditary Angioedema
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... 24, 2016 Research and ... "Structural Electronics 2015-2025: Applications, Technologies, Forecasts" report ... In-Mold Electronics, Smart Skin, Structural Health Monitoring, ... Structural electronics involves electronic and/or electrical components ... replacing dumb structures such as vehicle bodies or ...
(Date:6/24/2016)... 24, 2016 According to a ... (Standard Pen Needles, Safety Pen Needles), Needle Length (4mm, ... Hormone), Mode of Purchase (Retail, Non-Retail) - Trends & ... studies the market for the forecast period of 2016 ... 2.81 Billion by 2021 from USD 1.65 Billion in ...
(Date:6/23/2016)... 23, 2016 Research and Markets has ... - Forecast to 2022" report to their offering. ... for the patients with kidney failure, it replaces the function ... the patient,s blood and thus the treatment helps to keep ... in balance. Increasing number of ESRD patients ...
Breaking Medicine Technology:
(Date:6/25/2016)... , ... June 25, 2016 , ... On Friday, June ... a Bronze Wellness at Work award to iHire in recognition of their exemplary accomplishments ... of the 7th annual Maryland Workplace Health & Wellness Symposium at the BWI Marriott ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... Those who ... with these feelings, many turn to unhealthy avenues, such as drug or alcohol abuse, ... Marne, Michigan, has released tools for healthy coping following a traumatic event. , Trauma ...
(Date:6/24/2016)... ... 2016 , ... The Pulmonary Hypertension Association (PHA) learned during ... two significant new grants to support its work to advance research and patient ... recognizing patients, medical professionals and scientists for their work in fighting pulmonary hypertension ...
(Date:6/24/2016)... ... June 24, 2016 , ... Comfort Keepers® of San ... Society and the Road To Recovery® program to drive cancer patients to and from ... adults to ensure the highest quality of life and ongoing independence. Getting to ...
(Date:6/24/2016)... ... 24, 2016 , ... EB Medicine presented its first-ever “Issue ... conference in Ponte Vedra Beach, FL. The awards honor the outstanding work of ... and Pediatric Emergency Medicine Practice. , “With this award, we recognize the ...
Breaking Medicine News(10 mins):