Navigation Links
Biopure Reports on Meeting with the FDA
Date:9/6/2007

CAMBRIDGE, Mass., Sept. 6 /PRNewswire-FirstCall/ -- Biopure Corporation (Nasdaq: BPUR) today announced that it had recently met with the FDA to discuss the compassionate use protocol submitted by the company in July. At the FDA's suggestion, the company intends to submit a protocol for a Phase 2 randomized trial for the treatment of autoimmune hemolytic anemia and other forms of hemolytic anemia, including alloantibody anemia but excluding sickle cell anemia. Hemopure has been used previously, on a compassionate use basis, to treat patients with these conditions.

The proposed patient group was included in the compassionate use protocol previously proposed to the FDA. A study protocol for the treatment of autoimmune hemolytic anemia and other forms of hemolytic anemia would be in place of that compassionate use protocol. Biopure may continue to work with the FDA on compassionate use cases through single patient INDs that are requested from treating physicians.

Autoimmune hemolytic anemia is a group of disorders characterized by a malfunction of the immune system that produces antibodies to the patient's red blood cells attacking them as if they were substances foreign to the body. This group of disorders is uncommon, can occur at any age and affects women more often than men.

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. Biopure has applied in the United Kingdom for regulatory approval o
'/>"/>

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

Page: 1 2 3

Related medicine technology :

1. Corgenix Reports New Clinical Data Correlating AtherOx Technology With Vascular Disease
2. Cobalis Reports Phase III Trial Results for PreHistin in Seasonal Allergic Rhinitis
3. Cosmo Pharmaceuticals Reports Positive Preliminary Phase II/III Data with Rifamycin MMX in Infectious Diarrhea
4. Cytos Biotechnology Reports Results from Phase IIa Study with CYT003-QbG10 in Patients Suffering from Atopic Dermatitis
5. Cytokinetics Reports Additional Clinical Trials Data for Ispinesib
6. The European Myeloma Platform Reports New Survival data for Revlimid Presented at the International Myeloma Workshop in Greece
7. Cytochroma Reports Positive Phase I Clinical Data for CTA018 Injection
8. Speedel Reports Successful SPP635 Phase IIa Trial in Hypertension
9. Columbia Laboratories Reports Positive Results from Multi-dose Pharmacokinetic Study of Vaginally-administered Lidocaine
10. CytRx Reports Promising Data from Its Open-Label Extension Clinical Trial of Arimoclomol in ALS
11. Affymax Reports Phase 2 Clinical Dose Ranging Results of Once-Per-Month Hematide for the Treatment of Anemia
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/27/2015)... , Feb. 27, 2015  Following a ... Committee that moved H.R. 284, the Medicare DMEPOS ... American Association for Homecare (AAHomecare) released a statement ... action to pass the legislation. "Today,s ... the House Ways and Means Committee is a ...
(Date:2/27/2015)... -- Securities lawyers at Dunnam & Dunnam ... SLXP ) in connection with a buyout ... encouraged to contact attorney Hamilton Lindley by clicking ... the shareholder value of the transaction. Under terms of ... per share in cash. At least one analyst has ...
(Date:2/27/2015)... HOUSTON, TX , Feb. 27, 2015 /PRNewswire/ - ESSA ... Bloom Burton & Co. Ltd. ("Bloom Burton") today announced ... "Lock-Up") 2,353,130 common shares of the Company ("Common Shares") ... the Lock-Up. Of the Common Shares released from the ... release from the Lock-Up while the remainder will be ...
Breaking Medicine Technology:Bidding Fix Takes Major Step Forward After Bipartisan Vote of House Ways and Means Committee 2ESSA Pharma and Bloom Burton announce additional release of shares from voluntary lock-up agreement 2ESSA Pharma and Bloom Burton announce additional release of shares from voluntary lock-up agreement 3ESSA Pharma and Bloom Burton announce additional release of shares from voluntary lock-up agreement 4
... Sleep, the West Coast,s largest and fastest growing independent ... sleep clinic in Oakland, California.  Located one block from ... open for business. Services include sleep physician consultations, diagnostic ... other therapies for patients diagnosed with Obstructive Sleep Apnea ...
... Nov. 14, 2011 NeuroCog Trials, Inc. and Advance ... recordings of neurocognitive testing in a large international clinical ... errors in test administration and scoring.  This video recording ... accurate, unbiased assessment of neuropsychological effects of new drugs. ...
Cached Medicine Technology:Bay Sleep Clinic Continues Growth in California and Beyond 2NeuroCog Trials Captures Video Recordings of Neurocognitive Testing in a Multinational Clinical Trial 2NeuroCog Trials Captures Video Recordings of Neurocognitive Testing in a Multinational Clinical Trial 3
(Date:2/28/2015)... The World Scout League Commission (WSLC), an ... EMTs and firefighters, recently announced its decision to host ... raise charitable donations for age-related research. The five-kilometer race, ... held on March 29, 2015; registration will start at ... p.m. , To participate in the race, runners ...
(Date:2/28/2015)... 1Heart Caregiver Services CEO Belina ... at Houston Texas Franchise Expo South and IFA ... executive delegates headed by Vice-President of Operations Kevin ... Randolph Clarito. , Franchise Expo South, sponsored by ... 4-7 and featured Franchise brands of every industry ...
(Date:2/27/2015)... Wireless Analytics, an award-winning ... of the founders of the wireless expense ... within their CLEAN Platform™ (Communications Lifecycle Expense Analytics) ... newly developed Bell Mobility Data Loader enables unprecedented ... carrier’s business customers. , Wireless Analytics cites customer ...
(Date:2/27/2015)... A new study published in the Journal of ... on a regular basis and prostate cancer. While cycling is ... more hours per week a man spends cycling, the more ... increased importance on prostate cancer screening methods. , “This study ... at patents’ risk factors for developing prostate cancer,” says Kia ...
(Date:2/27/2015)... (PRWEB) February 27, 2015 ... “cutters”, are often misunderstood, misdiagnosed and therefore ... to healthy lives. Jacksonville-based addiction treatment ... of its highly acclaimed Lakeview Professional Lecture ... interested in understanding this complicated condition. ...
Breaking Medicine News(10 mins):Health News:Bitcoin Run Is The World Scout League Commission’s Newest Project for Charity 2Health News:1Heart Caregiver Services Showcases Emerging Brand at Franchise Expo South and IFA Annual Convention 2Health News:1Heart Caregiver Services Showcases Emerging Brand at Franchise Expo South and IFA Annual Convention 3Health News:Bell Mobility Gains Traction With Enterprises; Is Added to Wireless Analytics’ CLEAN Platform™ 2Health News:Bell Mobility Gains Traction With Enterprises; Is Added to Wireless Analytics’ CLEAN Platform™ 3Health News:Study Finds That Cycling Increases Risk For Prostate Cancer 2Health News:Study Finds That Cycling Increases Risk For Prostate Cancer 3Health News:Lakeview Health to Host Important Workshop Tackling the Rising Issue of ‘Cutters’ on March 27 2
... It's no surprise that constant stress can make people sick, ... ,A study focused on 119 men and women who were ... caregivers was compared with that of 106 people of similar ... care giving. Blood tests showed that a chemical called Interleukin-6 ...
... million children worldwide die every year, most of them in ... treatments. While the childhood mortality rate in these nations has ... peaked in 1980. About half of the deaths in children ... Pakistan, Democratic Republic of Congo, and Ethiopia) and 90 percent ...
... who are bitten by animals poses little problem for doctors, ... human? ,That’s the question researchers set out to answer in ... and Neck Surgery. Their review of 10 years worth of ... believe can form a standard protocol to follow when man ...
... for preventing disease. In the future, skin ,cancer detection may ... Hattaway is a nine-year ,survivor of melanoma. He’s lucky doctors ... never found a primary, which is what you call the ... the skin. It had already gotten into my lymph system,” ...
... to prevent or delay the onset of prostate cancer, ... cancers. ,More than 18,000 men were randomized , age ... At baseline, digital rectal examination results were normal in ... more than 3.0 ng/mL. Among the 4368 men in ...
... delay the onset of prostate cancer, however, finasteride may ... 18,000 men were randomized , age 55 or older ... rectal examination results were normal in all subjects, and ... ng/mL. Among the 4368 men in the finasteride group ...
Cached Medicine News:
Inquire...
... Basic ergonomic chairs with concave ... support • Select options like seats, ... • BTP/1Q-PAL chairs are recommended for ... clean room, static control, health care ...
... concave seats and standard-sized backrests with ... seats, backrests, armrests, and casters and ... for the following environments: industry, education, ... care and office. • With polished ...
... chairs with concave seats and standard-sized ... options like seats, backrests, armrests, and ... are recommended for the following environments: ... control, health care and office. • ...
Medicine Products: