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FDA, ADVENTRX reach agreement for ANX-514 trial

Thursday, October 27, 2011 11:03 AM

ADVENTRX Pharmaceuticals met with the FDA to discuss a single clinical study to support approval of ANX-514 (docetaxel for injectable emulsion), a detergent-free reformulation of Taxotere.

ADVENTRX proposed a non-inferiority study (Study 514-02) with a primary objective of comparing fluid retention following treatment with ANX-514, administered without corticosteroid premedication, and Taxotere, administered with corticosteroid premedication, which would enroll approximately 400 patients.  The FDA agreed that the proposed study would generate sufficient clinical data to support approval of ANX-514 without requiring corticosteroid premedication.

Eric K. Rowinsky, M.D., principal clinical advisor to ADVENTRX, said, "Eliminating the high-dose corticosteroid premedication required with Taxotere would represent a significant benefit to cancer patients.”

“Corticosteroids expose cancer patients to otherwise unnecessary and costly complications, such as hyperglycemia, immunosuppression and insomnia. ANX-514 has the potential to improve the tolerability and safety of docetaxel treatment while eliminating toxicities caused by the polysorbate 80 detergent and complications associated with the Taxotere premedication regimen,” said Rowinsky.

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