Mast Therapeutics, Inc. (MSTX)

[Ecomike]

News:

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.

"Frequent contact with FDA is critical to the success of our clinical programs, and the number of our upcoming meetings with FDA demonstrates our commitment in this regard. Following these meetings, we intend to provide updates with respect to key events for each of our programs, including timelines for study initiation, study completion and NDA submission," said Brian M. Culley, Chief Executive Officer of ADVENTRX. "In the meantime, we continue to prepare to initiate the ANX-188 and ANX-514 pivotal studies next year. Our cash and equivalents, which were $40.7 million at July 31, allow us to make substantial progress on these programs," Mr. Culley added.

About ADVENTRX Pharmaceuticals

ADVENTRX Pharmaceuticals is a specialty pharmaceutical company focused on developing proprietary product candidates. The Company's current lead product candidates are ANX-188, a novel, purified, rheologic and antithrombotic compound initially being developed as a first-in-class treatment for pediatric patients with sickle cell disease in acute crisis, and ANX-514, a detergent-free reformulation of the blockbuster drug Taxotere, which recently went off-patent. The Company is evaluating its Exelbine program following the complete response letter it received from the FDA. More information can be found on the Company's web site at www.adventrx.com.