SAN DIEGO, Oct. 26, 2011 /PRNewswire/ -- ADVENTRX Pharmaceuticals, Inc. (NYSE Amex: ANX) announced today that it met with the U.S. Food and Drug Administration (FDA) to discuss a single clinical study to support approval of ANX-514 (docetaxel for injectable emulsion), a detergent-free reformulation of Taxotere (docetaxel).
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."
Brian M. Culley, Chief Executive Officer of ADVENTRX, said, "We are very pleased to have reached agreement with the FDA on a reasonable path to approval for ANX-514. Our focus is on initiating Study 514-02 as soon as possible and submitting an NDA in 2014."Mr. Culley continued: "The high-dose steroids required with Taxotere are problematic for all cancer patients, and in particular those who have diabetes or a predisposition to hyperglycemia, who we estimate constitute one-third of the patients who receive Taxotere." About Study 514-02 Study 514-02 will be a randomized, open-label, multicenter, non-inferiority study comparing ANX-514, administered without corticosteroid premedication, and Taxotere, administered with corticosteroid premedication, in the treatment of non-small cell lung cancer after failure of prior platinum-based therapy. Approximately 400 patients will be enrolled and treated until evidence of progressive disease, unacceptable toxicity, withdrawal of consent, or other withdrawal criteria are met. The primary objective will be to compare the incidence of fluid retention between study arms. The secondary objectives will be to compare ANX-514 and Taxotere in terms of overall safety profile, objective response rate, duration of response, progression-free survival and overall survival.