Cordex Pharma Submits to the FDA an Amended Special Protocol Assessment ... ( LA JOLLA Calif. Feb. 18 /- Cordex Pha...)

Cordex Pharma Submits to the FDA an Amended Special Protocol Assessment for ATPace

Date:2/18/2009

LA JOLLA, Calif., Feb. 18 /PRNewswire-FirstCall/ -- Cordex Pharma, Inc. (OTC Bulletin Board: CDXP) announced today that it has submitted to the U.S. Food and Drug Administration (FDA) an amended Phase 3 protocol for ATPace to be reviewed as a Special Protocol Assessment (SPA). The amendment addresses written comments recently received from the FDA in response to the Company's initial SPA submission to the FDA on November 20, 2008.

To address the FDA's main comments, Cordex has changed the design of the pivotal clinical trial as follows:

               (1) To demonstrate drug efficacy and establish an optimal
                   dose-regimen: A parallel four-arm trial design will consist
                   of three doses of ATPace (5, 10, and 20 mg) and placebo.
               (2) To demonstrate drug safety: The number of studied patients
                   receiving the initial dose per proposed drug's label has
                   been increased to 100.

Amir Pelleg, Ph.D., Cordex's President and Chief Scientific Officer commented, "We are very pleased with the FDA's timely response to our initial ATPace SPA submission. We now believe that the written correspondence from the FDA, which clearly outlines all study-design requirements and clinical endpoints, would enable us to generate the efficacy and safety data required for the marketing approval of ATPace. We look forward to initiating the pivotal Phase 3 clinical trial for ATPace in PSVT patients."

Cordex will host a teleconference on Friday, February 20, at 10:00 a.m. EST to provide a fourth quarter business review and drug development update including a discussion of this SPA submission. Cordex's Chief Executive Officer, James S. Kuo, M.D., M.B.A., will give the presentation and there will be a question-and-answer session immediately afterwards.

To participate in the teleconference, please call toll-free 800.894.5910 (direc
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