Industry News/Clinical Trials

FDA Clearance Received To Begin Human Testing of Cancer Drug

Published in Blood Weekly, September 25th, 1995

Sparta Pharmaceuticals, Inc., Research Triangle Park, North Carolina, announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to test a preparative therapy for bone-marrow transplants in a twenty patient Phase I clinical trial.

The compound to be tested, busulfan, is currently approved by the FDA for use in oral dose form, and marketed by another company, for treatment of chronic leukemia. However, it is also being used off-label by transplant physicians as preparative chemotherapy prior to bone-marrow transplants. Sparta Pharmaceuticals' busulfan formulation is an injectable, prepared with the company's proprietary Spartaject...

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Source: Blood Weekly (1995-09-25)

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