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 trials are ongoing. The clinical program was initially designed to evaluate Hemopure as a replacement for red blood cell transfusions, by providing an Oxygen Bridge(TM) in the setting of acute surgical anemia. More than 800 subjects have received HBOC- 201 and dosing ranged from 25g to 1230g of HBOC-201 administered over a period of up to eighteen days.

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 of a proposed orthopedic surgical anemia indication. The company is developing Hemopure for a potential indication in cardiovascular ischemia, in addition to 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 by the U.S. Food and Drug Administration and the European Commission, is indicated for the treatment of anemia in dogs. Biopure has sold approximately 186,000 units of Oxyglobin, which have been used to treat an estimated 100,000 animals.

Statements in this release that are not strictly historical are forward- looking statements, including those statements implying that the FDA will approve the draft study protocol for the use of Hemopure in the U.S. in certain life-threatening situations, the patients eligible for any such study, and any statements that might imply that Hemopure may receive marketing approval in additional jurisdictions or for additional indications. Actual results and their timing may differ materially from those projected in these forward-looking statements due to risks and uncertainties. These risks include, without limitation, uncertainties regarding the company's financial position, unexpected costs and expenses, delays and adverse determinations by regulatory authorities, unanticipated problems with the product's commercial use, whether or not product related, and with product distributors, sales agents or other third parties, and delays in or unpredictable outcomes of clinical trials, and the factors identified under the heading "Risk Factors" in the company's quarterly report on Form 10-Q filed on June 14, 2007, which can be accessed in the EDGAR database at the U.S. Securities and Exchange Commission's (SEC) website, http://www.sec.gov. The company undertakes no obligation to release publicly the results of any revisions to these forward- looking statements to reflect events or circumstances arising after the date hereof. A full discussion of the company's operations and financial condition can be found in the company's filings with the SEC.

The content of this release does not necessarily reflect the position or the policy of the U.S. Government or the Department of Defense, and no official endorsement should be inferred.

Contact: Todd Wood Herb Lanzet (Investors)

Biopure Corporation H.L. Lanzet Inc.

(617) 234-6576 (212) 888-4570

IR@biopure.com lanzet@aol.com


'/>"/>
SOURCE Biopure Corporation
Copyright©2007 PR Newswire.
All rights reserved

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:6/24/2016)... DUBLIN , June 24, 2016 ... and Markets has announced the addition of the ... their offering. ... products and provides an updated review, including its applications ... covering the total market, which includes three main industries: ...
(Date:6/24/2016)... BEIJING , June 24, 2016 Dehaier ... or the "Company"), which develops, markets and sells medical ... China , signed a strategic cooperation agreement with ... as "Hongyuan Supply Chain") on June 20, 2016, to ... Under the strategic cooperation agreement, Dehaier will leverage Hongyuan ...
(Date:6/24/2016)... , June 24, 2016 According ... by Type (Standard Pen Needles, Safety Pen Needles), Needle ... GLP-1, Growth Hormone), Mode of Purchase (Retail, Non-Retail) - ... This report studies the market for the forecast period ... reach USD 2.81 Billion by 2021 from USD 1.65 ...
Breaking Medicine Technology:
(Date:6/25/2016)... (PRWEB) , ... June 25, 2016 , ... The temporary closing of Bruton Memorial Library ... City Observer , brings up a new, often overlooked aspect of head lice: the parasite’s ... for fumigation is not a common occurrence, but a necessary one in the event that ...
(Date:6/25/2016)... , ... June 25, 2016 , ... ... and non-athletes recover from injury. Recently, he has implemented orthobiologic procedures as a ... area —Johnson is one of the first doctors to perform the treatment. Orthobiologics ...
(Date:6/24/2016)... ... June 24, 2016 , ... Those who have experienced traumatic events may ... to unhealthy avenues, such as drug or alcohol abuse, as a coping mechanism. To ... for healthy coping following a traumatic event. , Trauma sufferers tend to feel a ...
(Date:6/24/2016)... ... , ... Global law firm Greenberg Traurig, P.A. announced that 20 Florida attorneys ... peers for this recognition are considered among the top 2 percent of lawyers practicing ... members of this year’s Legal Elite Hall of Fame: Miami Shareholders Mark D. ...
(Date:6/24/2016)... ... 2016 , ... People across the U.S. are sharpening their pencils and honing ... contest in which patients and their families pay tribute to a genetic counselor by ... Society of Genetic Counselors (NSGC) Annual Education Conference (AEC) this September. , In ...
Breaking Medicine News(10 mins):