LA JOLLA, Calif. and PARSIPPANY, N.J., Nov. 10 Duska Therapeutics, Inc., (OTC Bulletin Board: DSKA) and DSM Pharmaceuticals,Inc., announced today that they have entered into a preliminary agreement tocollaborate on the manufacture of commercial batches of ATPace for Duska'splanned pivotal Phase 3 clinical trial in paroxysmal supraventriculartachycardia (PSVT). ATPace will be produced at DSM's commercial facilities inGreenville, North Carolina.
ATPace, a stable liquid formulation of adenosine 5'-triphosphate (ATP) forintravenous injection, is an investigational drug for the acute termination ofPSVT. The bradycardic effect of ATP, in particular its blockade of atrio-ventricular nodal conduction, has been shown in numerous published clinicalstudies to safely and effectively terminate re-entrant PSVT involving theatrio-ventricular node. Design of a pivotal Phase 3 clinical trial for ATPacein PSVT is in the planning stage.
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 with PSVTin the United States alone.
Currently, adenosine is the only approved treatment for PSVT in the UnitedStates. Duska believes that the initial dose of ATPace will be significantlymore efficacious than the initial labeled dose of adenosine in terminatingPSVT. While both ATP and adenosine inhibit atrio-ventricular nodal conduction,ATP is believed to have dual inhibitory action; one mediated by adenosine, theproduct of its rapid enzymatic degradation, and the other a triggered vagalreflex. Vagal maneuvers aimed at enhancing vagal tone to the heart, andthereby suppressing atrio-ventricular nodal conduction, have been clinicallyused to terminate tachycardia. Injectable formulations of ATP have beenapproved in Europe for over 50 years as safe and efficacious treatments forPSVT.
Duska is in the process of modifying the proposed design of the Phase 3clinical trial in accordance with the FDA's comments and plans to submit arevised protocol to the FDA for Special Protocol Assessment procedureapproval. Duska intends to initiate a single, prospective, double-blind,placebo-controlled and randomized trial in patients presenting to theemergency room with PSVT to demonstrate ATPace's clinical safety and efficacy.Upon successful completion of the trial, Duska intends to file a New DrugApplication under section 505(b)(2).
"We chose DSM after a thorough analysis of their ability to manufactureATPace according to our specifications and timeline, as well as meet all ofthe FDA's requirements of a commercial drug manufacturer," stated Amir Pelleg,PhD, Duska's President and Chief Scientific Officer. "We believe that DSM hasan excellent working relationship with the FDA, experience with injectabledrug products, and a superior reputation in sterile manufacturing," he added.
"We are delighted to be supporting Duska Therapeutics in bringing thisimportant potential new therapy to market," said Hans Engels, President andBusiness Unit Director for DSM Pharmaceuticals, Inc. "Through ourcollaboration, we have experienced first-hand, Duska's commitment toexcellence in serving a market with the need for improved treatments."
"We are excited to add Duska to our customer base and look forward to theanticipated launch of this key product, as well as the potential future growthwith Duska," remarked Laura Parks, Senior Vice President, Marketing & Salesfor DSM.
About Duska Therapeutics, Inc.
Duska Therapeutics, Inc., (Duska) is a specialty pharmaceutical companythat develops new cardiovascular medicines based upon the emergingpharmacology 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 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 of heart failure. In addition, Duska has apreclinical program in which it plans to develop new chemical entities thattarget a newly discovered pathway in the pathophysiology of chronicobstructive pulmonary disease. For more information, visithttp://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 pharmaceuticaland biopharmaceutical industries. DSM's breadth of manufacturing servicesinclude the areas of steriles, orals and topicals, including dose formmanufacturing, scheduled drugs, clinical manufacturing, fill finishmanufacturing, and lyophilization services.
This press release contains forward-looking statements within the meaningof Section 21E of the Securities Exchange Act of 1934, as amended that involverisks and uncertainties that could cause actual events or results to differmaterially from the events or results described in the forward-lookingstatements. 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 areintended to identify such forward-looking statements. All statements in thisrelease regarding the future outlook related to Duska are forward-lookingstatements, including the statements that Duska's ATPace entering a pivotalPhase 3 clinical trial, Duska's CDP-1050 commencing a Phase 2 clinical trial,the belief that the initial dose of ATPace will be significantly moreefficacious than the initial labeled dose of adenosine in terminating PSVT,the belief that ATP has dual inhibitory action, the anticipated launch of thekey product and the potential future growth of Duska, the submission of arevised protocol to the FDA for Special Protocol Assessment procedureapproval, the initiation of a single, prospective, double-blind, placebo-controlled and randomized trial in patients presenting to the emergency roomwith PSVT to demonstrate ATPace's clinical safety and efficacy, the filing ofa New Drug Application under section 505(b)(2) and the development of newchemical entities to target a newly discovered pathway in the pathophysiologyof chronic obstructive pulmonary disease. The forward-looking statements aresubject to risks and uncertainties that could cause actual results to differmaterially from those set forth or implied by any forward-looking statements.Such risks include the risk that the clinical trial for approval of ATPace andthe Phase 2 clinical trial for our CDP-1050 may not be successful, the abilityof DSM to meet our specifications and timeline as well as the FDA requirementsof a commercial drug manufacturer and that our technology may not lead toexpected results including the development or the successful commercializationof technologies relating to the use of ATP. Additional uncertainties and risksare described in Duska's most recently filed SEC documents, such as its mostrecent annual report on Form 10-KSB, all quarterly reports on Form 10-QSB andany 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 athttp://www.sec.gov. All forward-looking statements are based upon informationavailable to Duska on the date hereof. Duska undertakes no obligation topublicly update or revise any forward-looking statements, whether as a resultof new information, future events or otherwise, other than as required by law.
SOURCE Duska Therapeutics, Inc.