Duska Therapeutics Applies For Phase 3 Special Protocol Assessment

Main Category: Cardiovascular / Cardiology
Also Included In: Regulatory Affairs / Drug Approvals;  Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 21 Nov 2008 - 0:00 PDT

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Duska Therapeutics, Inc., (OTC Bulletin Board: DSKA), announced 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 intravenous injection, is an investigational drug for the acute termination of PSVT. The bradycardic effect of ATP, in particular its blockade of atrio-ventricular (AV) nodal conduction, has been shown in multiple published clinical studies to safely and effectively terminate re-entrant PSVT involving the AV node. Injectable formulations of ATP, similar to ATPace, have been approved and marketed in Europe as pharmaceuticals for over 50 years as safe and efficacious treatments for PSVT.

Currently, adenosine is the only approved treatment for PSVT in the United States. 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 ATP and adenosine inhibit AV nodal conduction, ATP is believed to have dual inhibitory action, one mediated by adenosine, the product of its ATP's rapid enzymatic degradation, and the other a triggered vagal reflex. Vagal maneuvers, such as Valsalva maneuvers, aimed at enhancing vagal tone to the heart, and thereby suppressing atrio-ventricular nodal conduction, have been clinically used to terminate tachycardia in certain cases.

"The request for a SPA represents a significant milestone in the development of ATPace," stated James S. Kuo, MD, MBA, Duska's chief executive officer. "We believe that the Phase 3 clinical trial with ATPace should demonstrate the safety and efficacy of our drug in PSVT," he added.

About Duska

Duska is a specialty pharmaceutical company that develops new cardiovascular medicines based upon the emerging 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 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 trials. Duska's ATPace is expected to enter a pivotal Phase 3 clinical trial for the treatment of paroxysmal supraventricular tachycardia in Q1 2009. Duska's CDP-1050 is expected to commence a Phase 2 clinical trial for the treatment of heart failure early in 2009. In addition, Duska has a preclinical program to develop new chemical entities that target a recently discovered pathway in the pathophysiology of chronic obstructive pulmonary disease.

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 about Duska's ATPace entering a pivotal Phase 3 clinical trial in Q1 2009, Duska's CDP-1050 commencing a Phase 2 clinical trial in early 2009, the belief that the Phase 3 clinical trial with ATPace should demonstrate the safety and efficacy of our drug in PSVT, the belief that the initial dose of ATPace will be significantly more efficacious than the initial labeled dose of adenosine in terminating PSVT, the belief that ATP has dual inhibitory action, the anticipated launch of the key product, the initiation of a single, prospective, double-blind, placebo- controlled and randomized trial with ATPace upon reaching an agreement with the FDA, the filing of a New Drug Application under section 505(b)(2) upon successful completion of the trial and the development of new chemical entities to target a newly discovered pathway in the pathophysiology of chronic obstructive pulmonary disease. 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 clinical trial for approval of ATPace and the Phase 2 clinical trial for our CDP-1050 may not be successful, that we may not reach agreement with the FDA, that the FDA evaluation of our study protocols may not be favorable or adequate to support a license application submission, that we may not file a New Drug Application when anticipated if at all and that our technology may not lead to expected results including the development or the successful commercialization of technologies relating to the use of ATP. 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-Q 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