Pivotal Phase 3 Clinical Trial For Duska's ATPace In Planning Stage
LA JOLLA, Calif. and PARSIPPANY, N.J., Nov. 10 /PRNewswire-FirstCall/ -- Duska Therapeutics, Inc., (OTC Bulletin Board: DSKA) and DSM Pharmaceuticals, Inc., announced today that they have entered into a preliminary agreement to collaborate on the manufacture of commercial batches of ATPace for Duska's planned pivotal Phase 3 clinical trial in paroxysmal supraventricular tachycardia (PSVT). ATPace will be produced at DSM's commercial facilities in Greenville, North Carolina.
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 nodal conduction, has been shown in numerous published clinical studies to safely and effectively terminate re-entrant PSVT involving the atrio-ventricular node. Design of a pivotal Phase 3 clinical trial for ATPace in PSVT is in the planning stage.
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 with PSVT in the United States alone.
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 atrio-ventricular nodal conduction, 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. 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 ATP have been approved in Europe for over 50 years as safe and efficacious treatments for PSVT.
Duska is in the process of modifying the proposed design of the Phase 3 clinical trial in accordance with the FDA's comments and plans to submit a revised protocol to the FDA for Special Protocol Assessment procedure approval. Duska intends to initiate a single, prospective, double-blind, 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 of the trial, Duska intends to file a New Drug Application under section 505(b)(2).
"We chose DSM after a thorough analysis of their ability to manufacture ATPace according to our specifications and timeline, as well as meet all of the FDA's requirements of a commercial drug manufacturer," stated Amir Pelleg, PhD, Duska's President and Chief Scientific Officer. "We believe that DSM has an excellent working relationship with the FDA, experience with injectable drug products, and a superior reputation in sterile manufacturing," he added.
"We are delighted to be supporting Duska Therapeutics in bringing this important potential new therapy to market," said Hans Engels, President and Business Unit Director for DSM Pharmaceuticals, Inc. "Through our collaboration, we have experienced first-hand, Duska's commitment to excellence in serving a market with the need for improved treatments."
"We are excited to add Duska to our customer base and look forward to the anticipated launch of this key product, as well as the potential future growth with Duska," remarked Laura Parks, Senior Vice President, Marketing & Sales for DSM.
About Duska Therapeutics, Inc.
Duska Therapeutics, Inc., (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 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 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 in which it plans 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.
About DSM Pharmaceuticals, Inc.
DSM Pharmaceuticals, Inc., a business unit of DSM Pharmaceutical Products, is a global provider of custom manufacturing services to the pharmaceutical and biopharmaceutical industries. DSM's breadth of manufacturing services include the areas of steriles, orals and topicals, including dose form manufacturing, scheduled drugs, clinical manufacturing, fill finish manufacturing, and lyophilization services.
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's ATPace entering a pivotal Phase 3 clinical trial, Duska's CDP-1050 commencing a Phase 2 clinical trial, 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 and the potential future growth of Duska, the submission of a revised protocol to the FDA for Special Protocol Assessment procedure approval, the initiation of a single, prospective, double-blind, placebo- controlled and randomized trial in patients presenting to the emergency room with PSVT to demonstrate ATPace's clinical safety and efficacy, the filing of a New Drug Application under section 505(b)(2) 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, the ability of DSM to meet our specifications and timeline as well as the FDA requirements of a commercial drug manufacturer 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-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.
|SOURCE Duska Therapeutics, Inc.|
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