Navigation Links
Biopure Phase III Orthopedic Trial Results Published in Journal of Trauma
Date:6/10/2008

CAMBRIDGE, Mass., June 10 /PRNewswire-FirstCall/ -- Biopure Corporation (Nasdaq: BPUR) today announced that the results from its Phase III orthopedic trial (HEM-115) have been published in the June 2008 issue of the Journal of Trauma. This paper is entitled "HBOC-201 as an Alternative to Blood Transfusion: Efficacy and Safety Evaluation in a Multicenter Phase III Trial in Elective Orthopedic Surgery."

"It is gratifying to have experts cull through the complex data repeatedly until insight into our product emerged," said Dr. A. Gerson Greenburg, Biopure Vice President, Medical Affairs and the paper's senior author.

The study, HEM-115 that included nearly 700 patients from 46 sites on three continents, is the largest Phase III clinical trial of the safety and efficacy of an HBOC as an option to avoid packed red blood cells (PRBC) in elective orthopedic surgery patients. The trial was designed to safely reduce and/or eliminate perioperative transfusion in patients who were expected to require transfusion of at least two units of PRBC as part of their procedure.

The paper's authors concluded that HBOC-201 eliminated the need for transfusion in the majority of patients. Patients < 80 years of age with moderate clinical needs safely avoided transfusions when treated with up to 10 units of HBOC-201. The intent-to-treat analysis was unfavorable with the crossover group (HBOC-201 to PRBC) being identified as the primary basis for the difference. The analytical methodology used identified that the crossover patients had a greater need for an oxygen carrier, likely related to patient age, volume overload and under-treatment.

The manuscript was authored by the principal investigator Jonathan S. Jahr, MD of the David Geffen School of Medicine at UCLA; Colin Mackenzie, MD of the National Study Center for Trauma & EMS, University of Maryland et al.

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.

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. Biopure Announces Publication of Phase II Proof-of-Concept Coronary Trial
2. Biopure Reports on Meeting with the FDA
3. Biopure Announces 2007 Third Quarter Financial Results
4. Biopure Seeks Compassionate Use Protocol for Treatment of Acute Anemia
5. Genmab A/S - Company Announcement Ofatumumab in Subcutaneous Study in Rheumatoid Arthritis Summary: Subcutaneous Administration of Ofatumumab Investigated in Phase I/II Study
6. NeurogesX Announces Publication of NGX-4010 Phase 3 HIV-Neuropathy Study Results in Neurology
7. Roche Moves Investigational Diabetes Drug, Taspoglutide, Into Phase III Clinical Trials
8. Alexza Completes Enrollment in Phase 3 Clinical Trial with AZ-004 (Staccato(R) Loxapine) for Acute Agitation
9. Alexza Announces Preliminary Results From its AZ-002 (Staccato(R) Alprazolam) Phase 2a Proof-of-Concept Trial in Patients With Panic Disorder
10. Medivation Initiates Second Pivotal Phase 3 Trial of Dimebon(TM) in Patients With Alzheimers Disease
11. Halozyme Therapeutics Announces Phase I Clinical Trial Results Demonstrating that the Combination of Recombinant Human Hyaluronidase (rHuPH20) With Humulin R(R) and with Humalog(R) Yields Faster, More Physiologic Insulin Kinetics and Better Predictability
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... SAN CLEMENTE, Calif. , June 24, 2016 /PRNewswire/ ... pulmonary function testing company, is now able to perform sophisticated lung ... ndd Medical Technologies , Inc. Patients are ... labs.  Thanks to ndd,s EasyOne PRO ® , ARL patients like ... any needed testing done in the comfort of her own home. ...
(Date:6/24/2016)... , June 24, 2016 ... appointment of Dr. Edward Futcher to ... Director, effective June 23, 2016.Dr. Futcher was also ... and Governance Committees.  As a non-executive member of ... expertise and strategic counsel to VolitionRx in connection ...
(Date:6/23/2016)... 2016 Any dentist who has made an implant ... process. Many of them do not even offer this as ... high laboratory costs involved. And those who ARE able to ... a high cost that the majority of today,s patients would ... Parsa Zadeh , founder of Dental Evolutions Inc. and inventor ...
Breaking Medicine Technology:
(Date:6/24/2016)... , ... June 24, 2016 , ... ... and Scientific Sessions in Dallas that it will receive two significant new grants ... grants came as PHA marked its 25th anniversary by recognizing patients, medical professionals ...
(Date:6/24/2016)... , ... June 24, 2016 , ... Comfort Keepers® of ... Cancer Society and the Road To Recovery® program to drive cancer patients to and ... other adults to ensure the highest quality of life and ongoing independence. Getting ...
(Date:6/24/2016)... , ... June 24, 2016 , ... ... at the Clinical Decision Making in Emergency Medicine conference in Ponte Vedra Beach, ... journal articles published in Emergency Medicine Practice and Pediatric Emergency Medicine ...
(Date:6/24/2016)... ... June 24, 2016 , ... Strategic Capital Partners, LLC (SCP) ... obtaining investment capital for emerging technology companies. SCP has delivered investment events ... in more than a million dollars of capital investment for five companies. ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... ... for human induced pluripotent stem (iPS) cells and other difficult to transfect cells, ... Cloning Medium. The PluriQ™ G9™ Gene Editing System is a complete ...
Breaking Medicine News(10 mins):