SAN DIEGO, Aug. 30, 2011 /PRNewswire/ -- ADVENTRX Pharmaceuticals, Inc. (NYSE Amex: ANX) today provided an update on its planned meetings with the U.S. Food and Drug Administration (FDA) regarding its three late-stage programs:
Exelbine (vinorelbine injectable emulsion)
- Type A meeting with FDA has been requested. This meeting is to discuss the complete response letter regarding the Company's New Drug Application (NDA) for Exelbine. The Company will present information that it believes demonstrates the authenticity of study drugs used in the pivotal study.
ANX-514 (docetaxel for injectable emulsion)
- Type B clinical meeting with FDA has been requested. This meeting is to discuss the pivotal safety study that FDA recommended at a meeting earlier this year. The Company is proposing a randomized, open-label study designed to descriptively evaluate the safety of ANX-514 without corticosteroid premedication and Taxotere® with corticosteroid premedication in non-small cell lung cancer.
- Type B CMC meeting with FDA has been requested. This meeting is to discuss the manufacture of ANX-514 for clinical trial material in connection with the planned pivotal safety study and for commercial product.
ANX-188 (purified poloxomer 188)
- Type B clinical meeting with FDA is planned for the fourth quarter of 2011. This meeting will be to confirm prior agreements with FDA, reach agreement on key aspects of the planned phase 3 pediatric study in sickle cell crisis and discuss the overall development plan.
- Type B CMC meeting with FDA is planned for the first quarter of 2012. This meeting will be to discuss the manufacture of ANX-188 for clinical trial material in connection with the planned phase 3 study and for commercial product.
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