Duska Therapeutics Receives Comments From FDA On Phase 3 ATPace(TM) Protocol Synopsis

Main Category: Cardiovascular / Cardiology
Also Included In: Regulatory Affairs / Drug Approvals;  Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 13 Aug 2008 - 2:00 PDT

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Duska Therapeutics, Inc. (OTC Bulletin Board: DSKA) ("Duska") announced 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 originating in the atria. It has been estimated that there are 89,000 new cases of PSVT per year and approximately 570,000 persons overall with 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 more efficacious than the initial labeled dose of adenosine in terminating PSVT. While both adenosine triphosphate and adenosine inhibit atrio-ventricular nodal conduction, adenosine triphosphate is believed to have dual inhibitory action; one mediated by adenosine, the product of its rapid enzymatic degradation, and the other, a triggered vagal reflex. Vagal maneuvers aimed at enhancing vagal tone to the heart, and thereby suppressing atrio-ventricular nodal conduction, have been clinically used to terminate tachycardia. Injectable formulations of adenosine triphosphate have been approved in Europe for over 50 years as safe and efficacious treatments for PSVT. Duska has established its own safety database for ATPace, which was obtained in its Phase 1 and 2 clinical trials, and has obtained more than 1,000 patients records from other clinical trials.

About Duska Therapeutics, Inc.

Duska Therapeutics, Inc. (Duska) is a specialty pharmaceutical company that develops new cardiovascular 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 investigational medicines, two of which are in late stages of clinical testing. Duska's ATPace(TM) is expected to enter a pivotal Phase 3 clinical trial for the treatment of paroxysmal supraventricular tachycardia. Duska's CDP-1050 is expected to commence a Phase 2 clinical trial for the treatment of heart failure. In addition, Duska has a preclinical program to develop new chemical entities that target a newly discovered pathway in the pathophysiology of chronic obstructive pulmonary disease. For more information, visit http://www.duskatherapeutics.com.

Forward looking Statements

This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended that involve risks and uncertainties that could cause actual events or results to differ materially from the events or results described in the forward-looking statements. The forward-looking statements are based on current expectations, estimates and projections made by management. Duska intends for the forward-looking statements to be covered by the safe harbor provisions for forward-looking statements. Words such as "anticipates," "expects," "intends," "plans," "believes," "seeks," "estimates," or variations of such words are intended to identify such forward-looking statements. All statements in this release regarding the future outlook related to Duska are forward-looking statements, including the statements that Duska plans to submit the revised Phase 3 clinical trial to the FDA for Special Protocol Assessment (SPA) procedure approval, Duska believes that the initial dose of ATPace(TM) will be significantly more efficacious than the initial labeled dose of adenosine in terminating PSVT, ATP is believed to have dual inhibitory action; one mediated by adenosine, the product of its rapid enzymatic degradation, and the other, a triggered vagal reflex, 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, Duska intends to file a New Drug Application under section 505(b)(2), Dr. Amir Pelleg believes 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, Duska's ATPace(TM) is expected to enter a pivotal Phase 3 clinical trial for the treatment of paroxysmal supraventricular tachycardia and Duska's CDP-1050 is expected to commence a Phase 2 clinical trial for the treatment of heart failure. The forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those set forth or implied by any forward-looking statements. Such risks include the risk that the revised protocol may not receive procedural approval, further clinical studies may be required prior to filing the NDA, the anticipated SPA procedure may not be applied to the proposed protocol, the clinical trial for approval of ATPace(TM) may not be successful, the NDA may be rejected and we may never successfully commercialize ATPace(TM) or CDP-1050. Additional uncertainties and risks are described in Duska's most recently filed SEC documents, such as its most recent annual report on Form 10-KSB, all quarterly reports on Form 10-QSB and any current reports on Form 8-K filed since the date of the last Form 10-KSB. Copies of these filings are available through the SEC website at http://www.sec.gov. All forward-looking statements are based upon information available to Duska on the date hereof. Duska undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, other than as required by law.

Duska Therapeutics, Inc.
http://www.duskatherapeutics.com