Duska Therapeutics and DSM Pharmaceuticals in Manufacturing Collaboration for PSVT Dr...( Pivotal Phase 3 Clinical Trial Fo...),Health

Pivotal Phase 3 Clinical Trial For Duska's ATPace In Planning Stage

LA JOLLA, Calif. and PARSIPPANY, N.J., Nov. 10 /PRNewswire-FirstCall/ -- Duska Therapeutics, Inc., (OTC Bulletin Board: DSKA) and DSM Pharmaceuticals, Inc., announced today that they have entered into a preliminary agreement to collaborate on the manufacture of commercial batches of ATPace for Duska's planned pivotal Phase 3 clinical trial in paroxysmal supraventricular tachycardia (PSVT). ATPace will be produced at DSM's commercial facilities in Greenville, North Carolina.

ATPace, a stable liquid formulation of adenosine 5'-triphosphate (ATP) for intravenous injection, is an investigational drug for the acute termination of PSVT. The bradycardic effect of ATP, in particular its blockade of atrio- ventricular nodal conduction, has been shown in numerous published clinical studies to safely and effectively terminate re-entrant PSVT involving the atrio-ventricular node. Design of a pivotal Phase 3 clinical trial for ATPace in PSVT is in the planning stage.

PSVT, one of the most common cardiac arrhythmias, is a rapid, regular heart rate originating in the atria. It has been estimated that there are 89,000 new cases of PSVT per year and approximately 570,000 persons with PSVT in the United States alone.

Currently, adenosine is the only approved treatment for PSVT in the United States. Duska 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 atrio-ventricular nodal conduction, ATP is believed to have dual inhibitory action; one mediated by adenosine, the product of its rapid enzymatic degradation, and the other a triggered vagal reflex. Vagal maneuvers aimed at enhancing vagal tone to the heart, and thereby suppressing atrio-ventricular nodal conduction, have been clinically used to terminate tachycardia. Injectable formulations of ATP have b
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