Cordex Pharma Submits To The FDA An Amended Special Protocol Assessment For ATPace

Main Category: Cardiovascular / Cardiology
Also Included In: Regulatory Affairs / Drug Approvals;  Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 19 Feb 2009 - 1:00 PST

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Cordex Pharma, Inc. (OTC Bulletin Board: CDXP) announced 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.

PSVT is an episodic, rapid, regular heart rate originating in the atria. The heart rate in PSVT can range from 150 to 250 beats per minute. There are approximately 570,000 persons with PSVT in the United States alone, with an estimated 89,000 new cases diagnosed each year. Patients with PSVT may report palpitations, pounding in the chest, chest pressure or pain, weakness, shortness of breath, or dizziness. Unless it self-terminates, PSVT patients need to seek medical intervention to terminate the arrhythmia.

ATPace is an investigational stable formulation of adenosine 5'-triphosphate (ATP) administered by intravenous injection for the acute termination of PSVT. The bradycardic effect of ATP, in particular its blockade of atrio-ventricular (AV) nodal conduction, has been shown in multiple published clinical studies to safely and effectively terminate re-entrant PSVT involving the AV node. Injectable formulations of ATP, similar to ATPace, have been approved and marketed in Europe for over 50 years as safe and efficacious pharmaceutical treatments for PSVT.

Currently, adenosine is the only approved drug for the acute treatment of PSVT in the United States. Cordex believes that the initial dose of ATPace will be significantly more efficacious than the initial labeled dose of adenosine in terminating PSVT. While both ATP and adenosine inhibit AV nodal conduction, ATP is believed to have dual inhibitory action, one mediated by adenosine, the product of ATP's rapid enzymatic degradation, and the other a rapid and potent ATP-triggered vagal reflex. Physical vagal maneuvers aimed at enhancing vagal input to the heart, and thereby suppressing atrio-ventricular nodal conduction, have been clinically used to terminate tachycardia in certain cases.

About Cordex Pharma, Inc.

Cordex is a specialty pharmaceutical company that develops new cardiovascular medicines based upon the emerging pharmacology of adenosine triphosphate (ATP) and nitric oxide (NO). These two molecules play critical roles in cellular metabolism and signal transduction, the manipulation of which constitute novel therapeutic modalities for the treatment of major cardiovascular disorders. Cordex has a portfolio of investigational medicines, two of which are in late stages of clinical development. Cordex's ATPace is expected to enter a Phase 3 clinical trial for the treatment of paroxysmal supraventricular tachycardia in 2009. Cordex's CDP-1050 is also expected to commence a Phase 2 clinical trial for the treatment of heart failure in 2009. In addition, Cordex has a preclinical program to develop new chemical entities that target a recently discovered pathway in the pathophysiology of chronic obstructive pulmonary disease. For further information regarding Cordex, please visit the company's website at http://www.cordexpharma.com.

Forward looking Statements

This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended that involve risks and uncertainties that could cause actual events or results to differ materially from the events or results described in the forward-looking statements. The forward-looking statements are based on current expectations, estimates and projections made by management. Cordex intends for the forward-looking statements to be covered by the safe harbor provisions for forward-looking statements. Words such as "anticipates," "expects," "intends," "plans," "believes," "seeks," "estimates," or variations of such words are intended to identify such forward-looking statements. All statements in this release regarding the future outlook related to Cordex are forward-looking statements, including, but not limited to, the statements regarding the timing of ATPace's expected entry into a pivotal Phase 3 clinical trial for the treatment of paroxysmal supraventricular tachycardia and the anticipated results of the trial, the timing of CDP-1050's expected commencement of a Phase 2 clinical trial for the treatment of heart failure, our ability to generate efficacy and safety data required for the marketing approval of ATPace, and the effects of the initial doses of ATPace. The forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those set forth or implied by any forward-looking statements. Such risks include the risk that the clinical trial for approval of ATPace and the Phase 2 clinical trial for our CDP-1050 may not be successful, that our preclinical program to develop new chemical entities that target a newly discovered pathway in the pathophysiology of chronic obstructive pulmonary disease may not be successful, and that our technology may not lead to expected results including the development or the successful commercialization of technologies relating to the use of ATP or nitric oxide. Additional uncertainties and risks are described in Cordex's most recently filed SEC documents, such as its most recent annual report on Form 10-KSB, all quarterly reports on Form 10-Q and any current reports on Form 8-K filed since the date of the last Form 10-KSB. Copies of these filings are available through the SEC website at http://www.sec.gov. All forward-looking statements are based upon information available to Cordex on the date hereof. Cordex undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, other than as required by law.

Cordex Pharma, Inc.
http://www.cordexpharma.com