• Adventrx Pharmaceuticals Inc., of San Diego, said it reached an agreement with the FDA on a single pivotal trial for ANX-514 (docetaxel for injectable emulsion) in cancer. The 400-patient study will be a noninferiority design with a primary endpoint of comparing fluid retention following treatment with ANX-514 administered without corticosteroid premedication, vs. Taxotere (docetaxel) administered with corticosteroid premedication. ANX-514 is designed to improve the tolerability and safety of docetaxel and decrease toxicities.
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