Biopure Corporation 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 anaemia 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 programme 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 anaemia secondary to the management and treatment of leukaemia 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: Severe, life threatening, or potentially life threatening anaemia; Blood transfusion is not feasible; All alternative treatment options have been exhausted; Adult male or female - 18 years of age, or child with anaemia 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 anaemia. 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 develops, manufactures and markets pharmaceuticals, called oxygen therapeutics, that are intravenously administered to deliver oxygen to the body's tissues. Hemopure [haemoglobin glutamer - 250 (bovine)], or HBOC-201, is approved for sale in South Africa for the treatment of surgical patients who are acutely anaemic. Biopure has applied in the United Kingdom for regulatory approval of a proposed orthopaedic surgical anaemia indication.