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News

Biopure discusses clinical trial for Hemopure with US FDA

Biopure : 08 July, 2008  (Company News)
Biopure has held discussions with the US FDA about identifying an acceptable patient population for a new clinical trial of Hemopure [haemoglobin glutamer - 250 (bovine)], or HBOC-201.
Biopure has proposed to study use of Hemopure in patients suffering from Acute Myelogenous Leukemia (AML) who refuse transfusion with blood components.

Currently, AML patients who do not accept blood transfusions are unable to undergo potentially life-saving induction chemotherapy because of the profound anemia the chemotherapy causes.

Biopure is preparing to submit a protocol for such patients for consideration by FDA. Patients would give informed consent before being enrolled in this study. An effective treatment for this patient population represents an unmet medical need because of an expected 100 percent mortality within six months in the absence of induction chemotherapy. The purpose of the study would be to assess the efficacy of Hemopure in providing an oxygen carrier in lieu of transfusion with red blood cells, as an adjunct to other special procedures, following induction chemotherapy for AML. A successful trial in this population could be pivotal to establish an intended use for Hemopure in this clinical setting.

'We are very excited at the possibility of initiating a new clinical trial with Hemopure in the US. If this trial provides convincing evidence of benefit in this high mortality population, it has the potential to become a pivotal trial for Hemopure's use as an adjunct to AML induction chemotherapy when transfusion with blood components is refused by the patient,' said Zafiris G. Zafirelis, Biopure chief executive officer and president. 'By serving as an oxygen delivery bridge following chemotherapy-induced suppression of red blood cell count, use of Hemopure, as part of a bloodless treatment regimen, may potentially reduce mortality in these patients, who currently have no hope.'
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