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Duska Therapeutics Submits Phase 3 ATPace(TM) Protocol to FDA for Comment
Date:7/23/2008

under Section 505(b)(2)".

Dr. Amir Pelleg, Duska's President and Chief Scientific Officer, stated, "I expect that the Special Protocol Assessment by the FDA would facilitate the completion of the clinical development of ATPace(TM) in a timely fashion".

About ATPace(TM)

ATPace(TM) (adenosine triphosphate injection) is a proposed product for the termination of paroxysmal supraventricular tachycardia (PSVT). The bradycardic effect of ATP, in particular its blockade of atrio-ventricular nodal (AVN) conduction, has been shown to effectively terminate re-entrant PSVT involving the AV node. Adenosine is the only approved competition in the U.S. Duska believes that the initial dose of ATPace(TM) will be significantly more efficacious than the initial labeled dose of adenosine in terminating PSVT. While ATP and adenosine both inhibit AVN conduction, ATPace(TM) is believed to have a second mechanism of action to stimulate vagally-mediated suppression of AVN conduction. Injectable formulations of ATP have been approved in Europe for over 50 years as safe and efficacious treatments for PSVT. Duska has completed Phase 1 and 2 clinical trials in diagnosing bradycardia, and has acquired more than 1,000 patients records from other clinical trials. Duska has met with the FDA to ascertain which additional requirements might be necessary for marketing approval of ATPace(TM). Duska plans a 505(b)(2) NDA filing route for approval.

About Duska Therapeutics, Inc.

Duska Therapeutics, Inc. (Duska) is a specialty pharmaceutical company that develops new cardiovascular and pulmonary medicines based upon the emerging new 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 by several pharmaceuticals constitute novel therapeutic modalities for the treatment of major cardiovascular disorders. Duska is developing a portfolio of investi
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SOURCE Duska Therapeutics, Inc.
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