Navigation Links
U.S. Naval Medical Research Center Proposed 'RESUS' Clinical Trial in Trauma Patients Remains on FDA Hold
Date:5/18/2009

CAMBRIDGE, Mass., May 18 /PRNewswire-FirstCall/ -- Biopure Corporation (Nasdaq: BPUR) announced today that the Food and Drug Administration has advised the U.S. Naval Medical Research Center (NMRC) by letter that it may not initiate a clinical trial of Biopure's oxygen therapeutic Hemopure(R) [hemoglobin glutamer -- 250 (bovine)] under a proposed protocol submitted to the FDA in March 2009. As previously announced, the study, "Restore Effective Survival in Shock" (RESUS) 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, including the most recent, 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 also developed and submitted a protocol for a trial proposed to be conducted in the field, called Operation RESUS (OP RESUS). 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." Op RESUS is also on clinical hold, and the company does not expect the FDA to permit RESUS or OP RESUS to proceed in the foreseeable future.

The company expects the NMRC to seek FDA approval for a clinical trial of Hemopure with a concomitant drug to address vasoactivity, which occurs with the use of Hemopure alone. The NMRC and the FDA are in discussions concerning such a trial, and the NMRC is
'/>"/>

SOURCE Biopure Corporation
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. U.S. Naval Medical Research Center Resubmits IND Application for Proposed RESUS Clinical Trial in Trauma Patients in the Out-of-Hospital Setting
2. U.S. Naval Medical Research Center Resubmits IND Application for Proposed Op RESUS Clinical Trial in Trauma Patients in the Battlefield Setting
3. Creighton Medical Laboratories First to Offer New Cancer Test
4. PLC Medical Systems to Demonstrate RenalGuard(R) at EuroPCR 2009
5. MedImmune Presents New Data Demonstrating Increased Risk for Medically Attended RSV in Late-Preterm Infants
6. China Sky One Medical, Inc. Achieves Significant Breakthrough in Research for Sudden Cardiac Death (SCD) Early Examination Kit
7. Perceptive Informatics Introduces Medical Imaging Methodology to Accelerate Development Decisions About Alzheimers Treatments
8. Tufts Medical Center Researchers Create a New Predictive Model for Age-related Macular Degeneration (AMD)
9. Raptor Pharmaceuticals Appoints Dr. Patrice P. Rioux as Chief Medical Officer
10. PEAK Surgical Announces Completion of First PRECISE Clinical Study, Receipt of Medical Design Excellence Award for PEAK(R) Surgery System and Achievement of Over 1,000 Surgeries Using PEAK PlasmaBlade(TM)
11. Torax Medical Launches Pivotal Clinical Study of New Acid Reflux Treatment
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/2/2014)... -- Particle Sciences, the leading CDMO for drug eluting ... manufacturing capabilities with the addition of a new 18mm ... Associate Director Clinical Production, "The company has been expanding ... equipment and staff across the board, all aimed at ... 6000ft 2 of operating cleanroom and cGMP warehouse ...
(Date:9/2/2014)... 2, 2014  Edison Nation Medical, the premier ... the American Association for Respiratory Care ( AARC ... specialists. Edison Nation Medical, which brings 12+ years ... commercialize their innovation ideas, will work with AARC ... than 50,000 respiratory therapists in bringing their product ...
(Date:9/2/2014)... , Sept. 2, 2014  PANTHERx Specialty ... Specialty Pharmacy Accreditation from URAC, a ... that establishes quality standards for the health care ... The URAC accreditation process demonstrates ... a framework to improve business processes through benchmarking ...
Breaking Medicine Technology:Particle Sciences Expands Drug Eluting Device Capabilities and Overall Clinical Trial Manufacturing Resources 2Edison Nation Medical and AARC Team Up To Promote Innovation in Respiratory Care 2Edison Nation Medical and AARC Team Up To Promote Innovation in Respiratory Care 3PANTHERx Specialty Pharmacy Applying for URAC Specialty Pharmacy Accreditation 2
... , , , ... With Eczema , , , ... launched guidance to,help parents reduce the burden of eczema on children living with this,disease. Experts from ... have come,together to agree a consensus of ,top tips, which focus on avoiding,situations that trigger painful ...
... , PITTSBURGH , May 19 Mylan Inc. ... private placement of $550 million aggregate principal amount of ... principal amount of 7.875% Senior Notes due 2020.  Mylan is using ... placement to prepay a portion of its outstanding term loans, thereby ...
Cached Medicine Technology:Experts Provide Guidance to Support Better Prevention of Eczema in Children 2Experts Provide Guidance to Support Better Prevention of Eczema in Children 3Experts Provide Guidance to Support Better Prevention of Eczema in Children 4Mylan Announces Completion of Senior Notes Offering 2
(Date:9/2/2014)... (PRWEB) September 02, 2014 Anti-aging ... products and services such as anti-wrinkle treatments and ... based treatments, and breast augmentation becoming much sought ... by U.S.-based market intelligence firm Transparency Market Research, ... products will grow to USD 191.7 billion by ...
(Date:9/2/2014)... CITY, GA (PRWEB) September 02, 2014 Last ... whole new level with the launch of a luxurious line ... to announce that the SEA ISLAND COTTON Socks are joining ... compression level, giving more people the comfort of natural cotton ... COTTON Socks, they are surprised to find socks as soft ...
(Date:9/2/2014)... (PRWEB) September 02, 2014 Alliance Strategies ... and multi-channel email marketing is pleased to announce it ... Firearms & Freedom as well as ... represent more than one million concerned Americans who can ... , “We are honored to continue providing our ...
(Date:9/2/2014)... What happens when you are hospitalized, but your ... arrive at the office for follow-up care, but ... about your hospital stay? Missing or incomplete ... (PCPs) can contribute to poor experiences and lead ... study shows that implementing guidelines can improve hospitals, ...
(Date:9/2/2014)... health risks, including heart disease and diabetes, but University ... mitigate one often-overlooked risk: not buckling up in the ... Jacobson, a professor of computer science and of mathematics, ... a decrease in seatbelt usage. However, these effects can ... "Primary seatbelt laws lead to increased use of seatbelts," ...
Breaking Medicine News(10 mins):Health News:Global Anti-aging Market Research Report 2018 by Transparency Market Research 2Health News:Global Anti-aging Market Research Report 2018 by Transparency Market Research 3Health News:SIGVARIS’ Luxury Line of Compression Socks, SEA ISLAND COTTON, Now Available in Stronger Compression Level 2Health News:ASG Continues to Bring New Lists to Market 2Health News:ASG Continues to Bring New Lists to Market 3Health News:Can data motivate hospital leaders to improve care transitions? 2Health News:Seatbelt laws encourage obese drivers to buckle up 2
... bit relaxed now. Genosis Inc, a US firm, has developed ... test has his and hers components a screening test ... the concentration of motile sperm, and a test for women ... ,The availability of the two-in-one test helps drive ...
... Depressed? Consider marriage as an option please, a pair of ... happier you could be after marriage . And never mind ... to benefit, claim Adrianne Frech, a sociology graduate student at ... ,They looked at a sample of 3,066 men and women ...
... WASHINGTON, D.C. A first-of-its-kind study presented at the 54th ... molecular imaging and nuclear medicine professionals , declares that ... tumor patients' response to treatment is a powerful predictor ... to the possibility that brain tumor patients may live ...
... of Preferred Provider Organizations (AAPPO) is launching a new ... care to those patients diagnosed with diabetes as ... An industry leader, AAPPO today kicked off its new ... take Action, Champion better care, and empower their patients ...
... announced today that HHS has awarded a contract for $500 ... manufacture and deliver 20 million doses of a next generation ... would be recommended in the event of a smallpox outbreak ... immune systems. The full supply of the vaccine will be ...
... Mental Health Services Administration (SAMHSA) today announced that ... three years to the state of Iowa ... The first year award is $400,000. This grant ... intervention and treatment services for youth suicide prevention ...
Cached Medicine News:Health News:Fertility Test at Home Possible With a New Kit 2Health News:Marriage Could Lift One Out of Depression, New Study 2Health News:Brain Tumor Patients Survival Depends on Predicting Treatment Responses Earlier 2Health News:AAPPO Launches ACT on Diabetes Initiative to Promote Improved Diabetes Care 2Health News:HHS Buys Next Generation Smallpox Vaccine 2Health News:HHS Buys Next Generation Smallpox Vaccine 3Health News:Iowa to Receive Grant Funding for Youth Suicide Prevention, Early Intervention 2
... Minimize Patient Trauma and Increase Staff Protection ... (10 Fr, 12 Fr, 14 Fr, 16 ... Suction Catheters with Contro-Vac Valves and DeLee ... potential for inflammation,during suctioning. Each catheter utilizes ...
SAFE-T-VAC Coil Packed Suction Catheters Kits, Sterile without Solution...
Sterile, Coil Packed Suction Catheter Mini Tray with (2) Walleted SAFESKIN PURPLE NITRILE Latex-Free Exam Gloves...
Clear plastic sleeve envelopes a plastic suction catheter. Sleeve slides over exudate to reduce potential clinician contact....
Medicine Products: