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On April 16, 2008, Duska met with the FDA and confirmed that a New DrugApplication under section 505(b)(2) would be the appropriate regulatorypathway for filing an ATPace marketing application for the acute treatment ofPSVT. Duska is in the process of modifying the proposed Phase 3 clinical trialin accordance with the FDA's comments it received and plans to submit arevised protocol to the FDA for Special Protocol Assessment procedureapproval. Duska intends to initiate a single, prospective, placebo-controlled,and randomized trial in patients presenting to the emergency room with PSVT todemonstrate ATPace's clinical safety and efficacy. Upon successful completion,Duska intends to file a New Drug Application under section 505(b)(2).
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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 pivotalPhase 3 clinical trial with ATPace are constructive and will allow us to moveexpeditiously forward in the development of this proposed drug for the acutetreatment of PSVT."
ATPace, adenosine triphosphate injection, is a proposed drug for thetermination of PSVT. The bradycardic effect of adenosine triphosphate, inparticular its blockade of atrio-ventricular nodal conduction, has been shownin multiple published clinical studies to safely and effectively terminatere-entrant PSVT involving the atrio-ventricular node.
PSVT, one of the most common cardiac arrhythmias, is a rapid, regularheart rate originating in the atria. It has been estimated that there are89,000 new cases of PSVT per year and approximately 570,000 persons overallwith PSVT in the United States alone.
Currently, adenosine is the only approved treatment for PSVT in the U.S.Duska believes that the initial dose of ATPace will be significantly moreefficacious than the initial labeled dose of adenosine in terminating PSVT.While both adenosine triphosphate and adenosine inhibit atrio-ventricularnodal conduction, adenosine triphosphate is believed to have dual inhibitoryaction; one mediated by adenosine, the product of its rapid enzymaticdegradation, and the other, a triggered vagal reflex. Vagal maneuvers aimed atenhancing vagal tone to the heart, and thereby suppressing atrio-ventricularnodal conduction, have been clinically used to terminate tachycardia.Injectable formulations of adenosine triphosphate have been approved in Europefor over 50 years as safe and efficacious treatments for PSVT. Duska hasestablished its own safety database for ATPace, which was obtained in itsPhase 1 and 2 clinical trials, and has obtained more than 1,000 patientsrecords from other clinical trials.
About Duska Therapeutics, Inc.
Duska Therapeutics, Inc. (Duska) is a specialty pharmaceutical companythat develops new cardiovascular medicines based upon the emerging newpharmacology of adenosine triphosphate (ATP) and nitric oxide (NO). These twomolecules play critical roles in cellular metabolism and signal transduction,the manipulation of which by several pharmaceuticals constitute noveltherapeutic modalities for the treatment of major cardiovascular disorders.Duska is developing a portfolio of investigational medicines, two of which arein late stages of clinical testing. Duska's ATPace(TM) is expected to enter apivotal Phase 3 clinical trial for the treatment of paroxysmalsupraventricular tachycardia. Duska's CDP-1050 is expected to commence a Phase2 clinical trial for the treatment o
