ADVENTRX Pharmaceuticals, Inc. (NYSE Amex: ANX) today announced it has submitted a request to the U.S. Food and Drug Administration (FDA) to schedule a meeting for the purpose of discussing its product candidate ANX-514 (docetaxel emulsion for injection). The FDA is expected to set the meeting date within 60 days of receiving the request from ADVENTRX.
"We have performed an extensive analysis of the data from our bioequivalence study of ANX-514, as well as on results from other trials using Taxotere®, and plan to discuss our findings at the meeting," said Brian M. Culley, Chief Executive Officer of ADVENTRX.
"Based in part on the substantial variability observed with Taxotere as reported in the literature, we believe the transitory elevations in total docetaxel concentrations for ANX-514 do not affect adversely its safety or efficacy relative to Taxotere. However, the FDA is the final arbiter of safety and efficacy and, following our meeting, we will provide an update on the next steps and requirements for advancing ANX514 toward an NDA submission," Mr. Culley continued.
ADVENTRX Pharmaceuticals, Inc.