Duska Therapeutics Applies for Phase 3 Special Protocol ...( LA JOLLA Calif. Nov. 20 /- Duska Ther...),Health

LA JOLLA, Calif., Nov. 20 /PRNewswire-FirstCall/ -- Duska Therapeutics, Inc., (OTC Bulletin Board: DSKA), announced today that it has submitted its pivotal Phase 3 ATPace clinical trial protocol for review under a Special Protocol Assessment (SPA) procedure with the U.S. Food and Drug Administration (FDA).

Subject to securing an agreement with the FDA, Duska intends to initiate a single, prospective, double-blind, placebo-controlled and randomized Phase 3 clinical trial with its lead product ATPace. This trial is aimed at demonstrating clinical safety and efficacy of ATPace in treating paroxysmal supraventricular tachycardia, or PSVT, in emergency room patients. Upon successful completion of the trial, Duska intends to file a New Drug Application under section 505(b)(2).

The SPA is a process that provides for an official FDA evaluation of Phase 3 clinical study protocols. Once the SPA is agreed to by both the FDA and the trial sponsor, the SPA provides the sponsor with a binding written agreement that the design and analysis of the studies are adequate to support a license application submission if the study is performed according to the SPA and if the results are successful. The SPA agreement may only be changed by the sponsor company or the FDA by a written agreement, or if the FDA becomes aware of a substantial scientific issue essential to product efficacy or safety.

PSVT, one of the most common cardiac arrhythmias, is a rapid, regular heart rate originating in the atria. 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. The heart rate in PSVT can range from 150-250 beats per minute.

ATPace, a stable liquid formulation of adenosine 5'-triphosphate (ATP) for intraven
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