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news.Biopure, a developer of oxygen therapeutics, has submitted to the FDA an investigational new drug or IND application to conduct a pilot Phase II clinical trial of the company's oxygen therapeutic Hemopure.
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In the proposed trial Hemopure would be studied for use in the treatment of anemia secondary to induction chemotherapy in patients with acute myeloid leukemia (AML) who refuse red blood cell transfusion.
The purpose of the proposed study would be to study the efficacy of Hemopure in delivering oxygen in the absence of red blood cell transfusion. An effective treatment for this patient population represents an unmet medical need because of an expected 100% mortality within several months without induction chemotherapy, the company said.