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Duska Therapeutics Applies for Phase 3 Special Protocol Assessment
Date:11/20/2008

ous injection, is an investigational drug 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 as pharmaceuticals for over 50 years as safe and efficacious treatments for PSVT.

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 AV nodal conduction, ATP is believed to have dual inhibitory action, one mediated by adenosine, the product of its ATP's rapid enzymatic degradation, and the other a triggered vagal reflex. Vagal maneuvers, such as Valsalva maneuvers, aimed at enhancing vagal tone to the heart, and thereby suppressing atrio-ventricular nodal conduction, have been clinically used to terminate tachycardia in certain cases.

"The request for a SPA represents a significant milestone in the development of ATPace," stated James S. Kuo, MD, MBA, Duska's chief executive officer. "We believe that the Phase 3 clinical trial with ATPace should demonstrate the safety and efficacy of our drug in PSVT," he added.

About Duska (http://www.duskatherapeutics.com):

Duska 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 cardiova
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SOURCE Duska Therapeutics, Inc.
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