Cancer Therapy

Pivotal phase III trial to begin for new stem cell transplant drug candidate

Published in Cancer Weekly, January 4th, 2005

AnorMED, Inc., (AOM) announced that it has received a response from the U.S. Food and Drug Administration (FDA) regarding its Special Protocol Assessment (SPA) on the design for two pivotal phase III clinical trials of AMD3100, a potential new stem cell mobilizing agent for stem cell transplantation in cancer patients.

A SPA provides a forum for the FDA and a company to reach agreement as to the design, execution, and analyses proposed for regulatory approval in protocols reviewed under this process.

Stem cell transplantation is a life saving medical procedure used to restore the immune system of patients who have had chemotherapy to treat...

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Source: Cancer Weekly (2005-01-04)

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