LA JOLLA, Calif., July 23 /PRNewswire-FirstCall/ -- Duska Therapeutics, Inc. ("Duska") announced today that it has submitted for comment a synopsis of a proposed Phase 3 clinical study for its lead drug, ATPace(TM), to the U.S. Food and Drug Administration's (the "FDA") Division of Cardiovascular and Renal Products.
Based on recent communications with the FDA, including a face-to-face meeting held on April 16, 2008, Duska believes that the proposed single, prospective, placebo-controlled, and randomized trial in patients presenting to the emergency room with paroxysmal supraventricular tachycardia (PSVT) should be sufficient to demonstrate clinical safety and efficacy. The proposed primary endpoint of the study is dose-dependent conversion of PSVT to normal sinus rhythm. The FDA has expressed willingness to review and comment on the proposed trial design according to the Special Protocol Assessment (SPA) procedure.
PSVT 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 in the United States alone. PSVT is one of the most common cardiac arrhythmias.
Duska has already compiled clinical data on the safety and efficacy of adenosine triphosphate (ATP), which is the active pharmaceutical ingredient in ATPace(TM), in the treatment of patients with PSVT. In addition, Duska has its own safety database on ATPace(TM), which was obtained in Phase 1 and 2 clinical trials. Based on these data, Duska believes that upon successful completion of the proposed Phase 3 trial, it would have all the clinical data necessary to support the filing of the NDA for ATPace(TM) under section 505(b)(2), the drafting of which has already commenced.
Dr. James Kuo, Duska's Chairman and CEO, said, "After our recent interactions with the FDA, I believe we have a clear plan to acquire all the data that would be necessary to support the filing of a NDA for ATPace(TM) 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 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 believes that the proposed single, prospective, placebo-controlled, and randomized trial in patients presenting to the emergency room with paroxysmal supraventricular tachycardia (PSVT) should be sufficient to demonstrate clinical safety and efficacy, that Duska believes that upon successful completion of the proposed Phase 3 trial, it would have all the clinical data necessary to support the filing of the NDA for ATPace(TM) under section 505(b)(2), the belief that Duska has a clear plan to acquire all the data that would be necessary to support the filing of a NDA for ATPace(TM) under Section 505(b)(2), and the expectation that the SPA by the FDA will facilitate the completion of the clinical development of ATPace(TM) in a timely fashion. 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 FDA comments about the prospective clinical design may not be favorable, that 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 and that the NDA may be rejected. 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.
CONTACT: James S. Kuo, M.D., M.B.A., Chairman and CEO of Duska
Therapeutics, Inc., +1-858-551-5700, Fax, +1-858-551-5704,
kuoj@duskascientific.com
Web site: http://www.duskatherapeutics.com/
