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Duska Therapeutics Receives Comments From FDA on Phase 3 ATPace(TM) Protocol Synopsis
Date:8/12/2008

LA JOLLA, Calif., Aug. 12 /PRNewswire-FirstCall/ -- Duska Therapeutics, Inc. (OTC Bulletin Board: DSKA) ("Duska") announced today that it has received comments from the U.S. Food and Drug Administration's (the "FDA") Division of Cardiovascular and Renal Products on a synopsis of a proposed Phase 3 clinical study with its lead drug, ATPace(TM), for the acute treatment of a frequent cardiac arrhythmia called paroxysmal supraventricular tachycardia (PSVT).

On April 16, 2008, Duska met with the FDA and confirmed that a New Drug Application under section 505(b)(2) would be the appropriate regulatory pathway for filing an ATPace marketing application for the acute treatment of PSVT. Duska is in the process of modifying the proposed Phase 3 clinical trial in accordance with the FDA's comments it received and plans to submit a revised protocol to the FDA for Special Protocol Assessment procedure approval. Duska intends to initiate a single, prospective, placebo-controlled, and randomized trial in patients presenting to the emergency room with PSVT to demonstrate ATPace's clinical safety and efficacy. Upon successful completion, Duska intends to file a New Drug Application under section 505(b)(2).

Dr. Amir Pelleg, Duska's President and Chief Scientific Officer, stated, "I believe that the comments of the FDA on our proposed design of a pivotal Phase 3 clinical trial with ATPace are constructive and will allow us to move expeditiously forward in the development of this proposed drug for the acute treatment of PSVT."

ATPace, adenosine triphosphate injection, is a proposed drug for the termination of PSVT. The bradycardic effect of adenosine triphosphate, in particular its blockade of atrio-ventricular nodal conduction, has been shown in multiple published clinical studies to safely and effectively terminate re-entrant PSVT involving the atrio-ventricular node.

PSVT, one of the most common cardiac arrhythmias, is a rapid, regular heart rate or
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SOURCE Duska Therapeutics, Inc.
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