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 tra
'/>"/>

SOURCE Biopure Corporation
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3

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:12/19/2014)... -- Since last month,s FBI shutdown of online drug ... leading online black market for illegal drugs - Evolution ... of drugs and other illegal items.  New numbers from ... in lowering the numbers of drugs and illegal items ... August. But some new sites that have emerged as ...
(Date:12/17/2014)... , Alemania, December 17, 2014 ... año anterior, con un alto nivel de gasto en ... año fiscal 2013/14 (finalizado el 30 de septiembre de ... ciento a 4.287 millones de euros (año anterior: 4.190 ... la moneda desfavorables. Las ganancias (EBIT) crecieron un 14 ...
(Date:12/17/2014)... 2014  Beamz Interactive, Inc. (OTCQB: BZIC), a ... announced that it has signed an agreement with ... of innovative prosthetic, orthotic and assistive technology products ... agreement, RSL Steeper will promote and supply the ... use within UK residential care facilities through its ...
Breaking Medicine Technology:Post Silk Road - Another Online Drug Den Now Dominates the DarkNet 2Post Silk Road - Another Online Drug Den Now Dominates the DarkNet 3ZEISS confirma su posición en un entorno difícil 2Beamz Interactive, Inc. Signs UK Distribution Agreement with RSL Steeper Limited 2Beamz Interactive, Inc. Signs UK Distribution Agreement with RSL Steeper Limited 3
(Date:12/19/2014)... (HealthDay News) -- Potentially illness-causing E. coli bacteria were ... markets, according to a new study. Researchers checked ... 13 farmers markets in Los Angeles and Orange counties ... almost 150 samples tested, 24 percent were positive for ... to the researchers. Both types of bacteria can ...
(Date:12/19/2014)... FRIDAY, Dec. 19, 2014 (HealthDay News) -- Dense bunches of ... and cancers, a new study finds. The researchers ... of the colon. The presence of these biofilms may ... a new way to predict a person,s risk for the ... on pond stones, these biofilms may coat the mucus layer ...
(Date:12/19/2014)... FRIDAY, Dec. 19, 2014 (HealthDay News) -- Older adults who ... and walking ability than people who still have at least ... findings suggest that total tooth loss could provide an early ... older people, the British researchers said. However, the findings ... decline. The study included more than 3,100 participants 60 ...
(Date:12/19/2014)... Diet Doc strives to continue to ... weight loss by combining scientific fast weight ... the company understand that remaining committed to a diet ... carbohydrates and sugars from the diet can cause patients ... weight loss goals. , For this reason, Diet ...
(Date:12/19/2014)... December 19, 2014 B. E. Smith, ... healthcare providers, has been retained to lead a national ... Medical Center in Estes Park, Colo. The top executive ... has recently placed more than 900 healthcare executives into ... a 25-bed, not-for-profit critical access hospital and level IV ...
Breaking Medicine News(10 mins):Health News:E. Coli Germs Found on Farmers Market Herbs 2Health News:Could Bacteria Play a Role in Colon Cancer? 2Health News:Loss of Teeth Linked to Physical, Mental Decline in Study 2Health News:Diet Doc Incorporates Appetite Zap into their Already Impressive Collection of Diet Products to Jump Start the Metabolism and Burn Fat 4X Faster 2Health News:Diet Doc Incorporates Appetite Zap into their Already Impressive Collection of Diet Products to Jump Start the Metabolism and Burn Fat 4X Faster 3Health News:Diet Doc Incorporates Appetite Zap into their Already Impressive Collection of Diet Products to Jump Start the Metabolism and Burn Fat 4X Faster 4Health News:Estes Park Medical Center Retains B. E. Smith to Recruit New Chief Financial Officer 2Health News:Estes Park Medical Center Retains B. E. Smith to Recruit New Chief Financial Officer 3
... based on successful,management of nearly 45,000 cases ... NEWPORT NEWS, Va., June 17 ... organization providing direct,case management services and healthcare ... and chronic diseases each year who are,unable ...
... Ore., June 17 Your 83-year old widowed mother,can no ... facility. But she is in,Florida, and you live in California. ... for a suitable assisted living or nursing,home in a strange ... care facility in the western United States and Florida. Available ...
... to help miilions of children in developing world, ... A new compound that may lead to an inexpensive, ... at the University of Texas Health Science Center at ... for developing countries, where diarrhea is a major cause ...
... , The use of the growth hormone in oral ... the integration between the bone base and the dental implant. ... weeks the wait time to place the crown which replaces ... been the resulto f the research of the doctoral thesis ...
... wait to see a doctor could get a lot longer ... care physicians doesn,t increase soon, according to a new University ... community medicine in the MU School of Medicine, and his ... of up to 44,000 family physicians and general internists in ...
... June 17 Among US primary care physicians,Novartis ... by,Pfizer, Merck, GlaxoSmithKline and Sanofi-Aventis, according to new,research ... spot in Europe,demonstrating a consistent ability to build ... rep relationship scores, it has,greater variability in Europe, ...
Cached Medicine News:Health News:Patient Data Analysis Report Finds More Than 75 Percent of Chronically Ill Patients Unable to Obtain Needed Healthcare Have Some Form of Insurance 2Health News:New Resource Available for Families Seeking Quality Care for Aging Parents 2Health News:Inexpensive Compound Could Treat Severe Diarrhea 2Health News:Scientists from Granada drastically reduce the wait time for new teeth implant 2Health News:US could face shortage of 44,000 primary care physicians by 2025 2Health News:US could face shortage of 44,000 primary care physicians by 2025 3Health News:Novartis, Pfizer and Merck Take the Lead on Strong Relationships with Physicians, as Doctors Demand an Expanding Set of Services 2Health News:Novartis, Pfizer and Merck Take the Lead on Strong Relationships with Physicians, as Doctors Demand an Expanding Set of Services 3Health News:Novartis, Pfizer and Merck Take the Lead on Strong Relationships with Physicians, as Doctors Demand an Expanding Set of Services 4
Unshielded...
... The Triage BNP Test is the ... test measuring B-type natriuretic peptide (BNP) ... ventricles in response to ventricular volume ... marker of ventricular systolic and diastolic ...
... Options System is designed to enable ... the knee or hip to regain ... the potential for restoration of function. ... requirements of a rotating hinge and ...
... The PROVISION Surgical Helmet System from DePuy ... protection. This system helps meet OSHA recommendations ... fluids, while creating a new standard for ... designed to offer unequaled comfort, featuring a ...
Medicine Products: