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Cordex Pharma Submits to the FDA an Amended Special Protocol Assessment for ATPace
Date:2/18/2009

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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
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SOURCE Cordex Pharma, Inc.
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