CAMBRIDGE, Mass., Aug. 23 Biopure Corporation(Nasdaq: BPUR) today announced that the company submitted a draft clinicalstudy protocol to the FDA for compassionate use of the investigational productHemopure (HBOC-201) in the United States. The proposed open label study wouldmake Hemopure available to patients for the treatment of life threatening orpotentially life threatening anemia on a compassionate use basis where bloodtransfusion is not an option.
The product has been available for compassionate use since December 2006.Under the existing program the company evaluates individual requests fromtreating physicians for specific patients. If the patient is deemed anappropriate candidate for treatment, the FDA is contacted and a single patientIND is requested. To date the FDA has authorized shipment of Hemopure for 20patients. Of the treated patients, four were experiencing severe anemiasecondary to the management and treatment of leukemia and lymphoma. Thebalance of the compassionate use cases were for the treatment of blood lossresulting from surgical complications or trauma. The remaining patients whowere not treated stabilized at the site by the time the drug was received.
The draft protocol outlines general eligibility criteria that include thefollowing:
The safety, efficacy and pharmacology of Hemopure have been studied in 22completed clinical trials. An additional four trials are ongoing. Theclinical program was initially designed to evaluate Hemopure as a replacementfor red blood cell transfusions, by providing an Oxygen Bridge(TM) in thesetting 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 periodof up to eighteen days.
Biopure Corporation develops, manufactures and markets pharmaceuticals,called oxygen therapeutics, that are intravenously administered to deliveroxygen to the body's tissues. Hemopure(R) [hemoglobin glutamer - 250(bovine)], or HBOC-201, is approved for sale in South Africa for the treatmentof surgical patients who are acutely anemic. Biopure has applied in the UnitedKingdom for regulatory approval of a proposed orthopedic surgical anemiaindication. The company is developing Hemopure for a potential indication incardiovascular 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 DrugAdministration and the European Commission, is indicated for the treatment ofanemia 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 willapprove the draft study protocol for the use of Hemopure in the U.S. incertain life-threatening situations, the patients eligible for any such study,and any statements that might imply that Hemopure may receive marketingapproval in additional jurisdictions or for additional indications. Actualresults and their timing may differ materially from those projected in theseforward-looking statements due to risks and uncertainties. These risksinclude, without limitation, uncertainties regarding the company's financialposition, unexpected costs and expenses, delays and adverse determinations byregulatory authorities, unanticipated problems with the product's commercialuse, whether or not product related, and with product distributors, salesagents or other third parties, and delays in or unpredictable outcomes ofclinical trials, and the factors identified under the heading "Risk Factors"in the company's quarterly report on Form 10-Q