LA JOLLA, Calif., March 11, 2008 (PRIME NEWSWIRE) -- Duska Therapeutics, Inc. (OTCBB:DSKA), a biotechnology company developing medical products based on adenosine 5'-triphosphate (ATP) and P2 receptor-related technologies, announced today that its senior management and consultants are scheduled to meet with representatives of the U.S. Food and Drug Administration's (FDA) Division of Cardiovascular and Renal Products in April to discuss the regulatory pathway for obtaining marketing approval of ATPace(tm), an intravenous formulation of ATP.
Duska requested a Type C advisory meeting with the FDA to present, discuss and obtain answers to several questions submitted by the company related to the regulatory pathway of ATPace(tm). The company intends to file an NDA under Section 505(b)(2) of the FDA for ATPace(tm) as an antiarrhythmic drug for the conversion of paroxysmal supraventricular tachycardia (PSVT) to normal sinus rhythm. The company believes that the meeting with the FDA will yield a pathway for eventual marketing approval of the drug.
Currently, Duska has an Investigational New Drug application with the FDA on ATPace(tm) and has collected clinical data on ATPace(tm) in diagnosing bradycardic neurally-mediated syncope.
"Together with our CRO, CATO Research, we are looking forward to having a productive meeting with the FDA that we expect will enable us to bring ATPace to the U.S. market in an expeditious manner" said Dr. James Kuo, Duska's Chairman and Chief Executive Officer. "Duska's founders played a critical role in introducing the first adenosine product to the market, and we seek to put the first ATP pharmaceutical product on the U.S. market," he added.
About ATPace(tm) and PSVT
ATPace is a proposed, intravenous drug for the acute treatment and diagnosis of certain cardiac arrhythmias (abnormal heart rate). These include terminating PSVT, a rapid regular heart rate originating in the atria, and diagnosing bradycardia (slow heart rate), which is one of the main causes of syncope (fainting). PSVT is one of the most common cardiac arrhythmias and is currently treated in the U.S. with adenosine, a by-product of ATP. Intravenous ATP has been used in Europe as a diagnostic and therapeutic drug for more than five decades.
About Duska Therapeutics, Inc.
Duska Therapeutics, Inc., based in La Jolla, California, is an emerging biotechnology company that is focused on the development of therapeutic, medical device and diagnostic products related to adenosine 5'-triphosphate (ATP) and cell-surface P2 receptors (P2R). Duska owns or has exclusive license rights to a number of proprietary products, four of which are currently in various stages of development for the treatment and diagnosis of certain cardiac arrhythmias, enhancement of sperm motility, treatment of chronic obstructive pulmonary disorder, and mitigation of the toxic effects of radiation exposure. For more information, visit Duska's website at http://www.duskatherapeutics.com.
Forward-looking statements
This press release may contain 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 but not limited to expectations as to the results and productivity of the meeting with representatives of the FDA, our ability and the manner in which we market ATPace in the US and our intent to put the first ATP pharmaceutical product on the US market. 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 including the risk that the meeting with the representatives of the FDA may not occur or that it may not occur when scheduled. 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 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.