US FDA calls for additional study on ADVENTRX' ANX-514
US firm ADVENTRX Pharmaceuticals (NYSE Amex: ANX) received a disappointment regarding its cancer product candidate ANX-514 (docetaxel emulsion, a reformulation of Sanofi-Aventis’ blockbuster chemotherapeutic Taxotere) when the US Food and Drug Administration said that the product could not be approved based on the findings from the bioequivalence study of ANX-514 (Study 514-01) and that additional development activities would be required for approval.
Commenting on a meeting with the agency, ADVENTRX chief executive Brian Culley said: "We are pleased with the outcome of our discussion with FDA, at which the conceptual design of a single, additional clinical study that could support approval of ANX-514 was discussed. We believe the study requested by the Agency is reasonable, and we are developing a study protocol for submission to the FDA. We will provide a further update after receiving feedback from FDA on the protocol."
Will continue development
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