Navigation Links
Biopure Seeks Compassionate Use Protocol for Treatment of Acute Anemia
Date:8/23/2007

CAMBRIDGE, Mass., Aug. 23 /PRNewswire-FirstCall/ -- Biopure Corporation (Nasdaq: BPUR) today announced that the company submitted a draft clinical study protocol to the FDA for compassionate use of the investigational product Hemopure (HBOC-201) in the United States. The proposed open label study would make Hemopure available to patients for the treatment of life threatening or potentially life threatening anemia on a compassionate use basis where blood transfusion is not an option.

The product has been available for compassionate use since December 2006. Under the existing program the company evaluates individual requests from treating physicians for specific patients. If the patient is deemed an appropriate candidate for treatment, the FDA is contacted and a single patient IND is requested. To date the FDA has authorized shipment of Hemopure for 20 patients. Of the treated patients, four were experiencing severe anemia secondary to the management and treatment of leukemia and lymphoma. The balance of the compassionate use cases were for the treatment of blood loss resulting from surgical complications or trauma. The remaining patients who were not treated stabilized at the site by the time the drug was received.

The draft protocol outlines general eligibility criteria that include the following:

-- Severe, life threatening, or potentially life threatening anemia

-- Blood transfusion is not feasible

-- All alternative treatment options have been exhausted

-- Adult male or female - 18 years of age, or child with anemia secondary

to severe burns

The safety, efficacy and pharmacology of Hemopure have been studied in 22 completed clinical trials. An additional four trial
'/>"/>

SOURCE Biopure Corporation
Copyright©2007 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. Point of Care Strep Tests Speed Treatment, Lower Costs
2. Rapid HIV Testing Increases Possibility of Treatment
3. Data Available From Erbitux Phase III Study in First-Line Treatment of Advanced Lung Cancer
4. Pixantrone Combination Therapy for First-line Treatment of Aggressive Non-Hodgkins Lymphoma Results in Reduction in Severe Toxicities Including Heart Damage When Compared to Doxorubicin-based Therapy
5. AVI BioPharma Partner Cook Medical Announces Completion of Patient Enrollment for APPRAISAL Phase II Clinical Trial for Treatment of Cardiovascular Disease
6. BusinessWeek Article Highlights Promising Breakthrough Treatment for Advanced Coronary Artery Disease
7. TransPharma Medical Announces Positive Results of Phase I Clinical Trials for Transdermal Delivery of hPTH (1-34) for Osteoporosis Treatment
8. TMC125 Showed Significant Virologic Response at Week 24 in Treatment-Experienced HIV Patients With NNRTI Resistance in Phase 3 Trials
9. New Phase 3 Study Published in The Lancet Evaluates Efficacy and Safety of Prezista/Ritonavir vs. Kaletra as Part of HIV Combination Therapy in Treatment-Experienced Adults With HIV
10. BusinessWeek Article Highlights Promising Breakthrough Treatment for Advanced Coronary Artery Disease
11. Peer Reviewed Journal Article Indicates Repros Proellex Exhibits Potential for New Approach to the Treatment and Prevention of Breast Cancer
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/1/2014)... , Oct. 1, 2014 Quantum Materials ... volume production of photoactive quantum dots for use ... While offering numerous advantages for solar power generation, ... quantities of quantum dots with which to develop ... them from commercial utilization and acceptance. The company ...
(Date:10/1/2014)... FREMONT, Calif. , Oct. 1, 2014 ... ARDX ), a clinical-stage biopharmaceutical company focused ... announced positive results from its 371 patient ... patients with constipation-predominant irritable bowel syndrome (IBS-C).  ... and clinically meaningful improvement in IBS-C symptoms ...
(Date:10/1/2014)... October 1, 2014 Sophia Genetics, ... Sequencing (NGS) data analysis, today launches a unique CFTR ... analysis in a single NGS experiment. The CE-IVD marked ... of variants in a single NGS experiment with clinical ... not been possible to simultaneously analyse all relevant CFTR ...
Breaking Medicine Technology:Quantum Materials Scaling Up Photoactive Quantum Dot Production for Solar Power Generation 2Quantum Materials Scaling Up Photoactive Quantum Dot Production for Solar Power Generation 3Ardelyx Reports Positive Results from Its Phase 2b Clinical Trial Evaluating Tenapanor in IBS-C Patients 2Ardelyx Reports Positive Results from Its Phase 2b Clinical Trial Evaluating Tenapanor in IBS-C Patients 3Ardelyx Reports Positive Results from Its Phase 2b Clinical Trial Evaluating Tenapanor in IBS-C Patients 4Ardelyx Reports Positive Results from Its Phase 2b Clinical Trial Evaluating Tenapanor in IBS-C Patients 5Ardelyx Reports Positive Results from Its Phase 2b Clinical Trial Evaluating Tenapanor in IBS-C Patients 6Sophia Genetics Launches Full CFTR Analysis in Single Clinical Grade NGS Experiment 2
... , ... Food and Drug Administration (FDA) has notified health professionals, and ... -- from the use of negative pressure wound therapy (NPWT). ... therapy devices can help in the healing and closure of ...
... , ... a leading provider of software solutions to optimize clinical ... release of StudyOptimizer 4, the latest iteration of its ... pharmaceutical companies, DecisionView,s flagship product now includes advanced historical ...
Cached Medicine Technology:Negative Pressure Wound Devices Draw FDA Notice, Advice 2DecisionView Launches StudyOptimizer(TM) 4 2DecisionView Launches StudyOptimizer(TM) 4 3
(Date:10/1/2014)... 01, 2014 Innovations announces the upcoming ... broadcast on Monday, October 20, 2014 at 7:30 a.m. ... will go behind the scenes to learn about Break ... will explore the practical help and information Break the ... the warning signs of abuse, how to navigate the ...
(Date:10/1/2014)... 01, 2014 Anti Aging Clinic (AntiAgingClinic.ca), ... rejuvenating destination of choice, is announcing a discounted cost ... to December. , “We’re doing this because we want ... our top skin clinic in Toronto,” says Dr. Brian ... much at Anti Aging Clinic, including laser facials, genesis ...
(Date:10/1/2014)... at the occasion of the Leishmaniasis East Africa ... and international leishmaniasis experts, results of a pharmacovigilance ... plan, carried out by MSF, DNDi, and ... were presented to key decision makers in order ... with the combination of Sodium Stibogluconate and Paromomycin ...
(Date:10/1/2014)... HILLS, CA (PRWEB) October 01, 2014 ... Reshad will speak to a group of dental specialists ... in the northern Spain city of Oviedo. Dr. Reshad ... prosthodontist and lecturer with clients on two continents, will ... complex and aesthetic full mouth reconstruction. , “These specialists ...
(Date:10/1/2014)... October 01, 2014 Two bicyclists began ... them across the country in an effort to raise ... families. The cyclists, a father-daughter team, plan to ... in Blaine, Washington and finishing in Key West Florida. ... For The Warriors®, a national nonprofit organization that assists ...
Breaking Medicine News(10 mins):Health News:Innovations to Explore Breakthroughs in Health and Wellness in Upcoming Episode Airing Monday, October 20, 2014 via Discovery Channel 2Health News:Anti Aging Clinic, the GTA’s Premier Provider of Anti Aging Treatments, Announces Deal on Units of Botox 2Health News:Results of large-scale roll out of combination treatment for kala-azar in Eastern Africa 2Health News:Woodland Hills Dental Implants Expert Training Dental Specialists in Spain Later This Week 2Health News:Woodland Hills Dental Implants Expert Training Dental Specialists in Spain Later This Week 3Health News:Woodland Hills Dental Implants Expert Training Dental Specialists in Spain Later This Week 4Health News:Father-Daughter Cycling Duo to Ride Cross-Country to Benefit Hope For The Warriors 2
... , , Gates ... and a Bright One , SEATTLE , Jan. ... & Melinda Gates Foundation, today released his second annual letter -- ... innovation impacts priorities of the foundation. , Gates is optimistic that, ...
... or ambidextrous, are more likely to have mental health, ... left-handed children, according to a new study published today ... researchers behind the study, from Imperial College London and ... teachers and health professionals to identify children who are ...
... shows it may have prevented, treated eye infections , ... makeup worn thousands of years ago by Queen Nefertiti ... to enhance beauty alone: New research suggests that the ... disease. , Some ancient Egyptians thought their lead-based ...
... ... billing and practice management services nationwide, announces today its’ addition of three exceptional leaders ... as Client Managers, while Jamie Hays has come aboard as the Client Accounting Manager. ... Columbus, OH ...
... , ... have identified brain networks damaged in Parkinson’s disease have new evidence that these systems ... network appear to respond in a last ditch attempt to rescue the brain. ... Manhasset, NY (Vocus) ...
... , SCOTTSDALE, Ariz. , Jan. 22 ... real estate investment trust, announced the execution of a purchase ... office portfolio located in Atlanta, Georgia for approximately ... to a number of conditions. , The medical office portfolio ...
Cached Medicine News:Health News:Bill Gates Releases Annual Letter 2Health News:Bill Gates Releases Annual Letter 3Health News:Mixed-handed children more likely to have mental health, language and scholastic problems 2Health News:Mixed-handed children more likely to have mental health, language and scholastic problems 3Health News:Explosive Growth Fuels Expansion of ADVOCATE's Management Team 2Health News:Explosive Growth Fuels Expansion of ADVOCATE's Management Team 3Health News:Brain Abnormalities in Parkinson's Patients Develop Before Symptoms Occur, According to Feinstein Scientists 2Health News:Brain Abnormalities in Parkinson's Patients Develop Before Symptoms Occur, According to Feinstein Scientists 3Health News:Healthcare Trust of America, Inc. Executes Agreement to Acquire 80,562 Square Foot Medical Office Portfolio Located in Atlanta, Georgia 2Health News:Healthcare Trust of America, Inc. Executes Agreement to Acquire 80,562 Square Foot Medical Office Portfolio Located in Atlanta, Georgia 3
Portex® Blue Line® cuffed endotracheal tubes come in a wide selection of sizes, each with a standard 15 mm ISO connector., ,Portex® Blue Line® endotracheal tubes are recognized world...
Portex® Blue Line® cuffed endotracheal tubes come in a wide selection of sizes, each with a standard 15 mm ISO connector., ,Portex® Blue Line® endotracheal tubes are recognized world...
... Plus™ Uncuffed Endotracheal Tube w. FlexiSlip™ Stylet, Murphy ... A quality Rusch endotracheal tube with a preloaded ... time and storage space. The stylet has a ... is designed with a soft distal tip to ...
Cuffed pediatric endotracheal tubes, available from 2.5 mm to 4.5 mm inside diameter. Ruschelit® PVC. Magill tip - nasoral. X-ray opaque line. Graduated. Single use. Sterile...
Medicine Products: