LA JOLLA, Calif., April 25 /PRNewswire-FirstCall/ -- Duska Therapeutics,
Inc. (OTC Bulletin Board: DSKA) ("Duska" or the "Company"), a biotechnology
company developing medical products based on adenosine 5'-triphosphate (ATP)
and P2 receptor-related technologies, announced today that the Company's
management and clinical and regulatory consultants met on April 16 with
members of the United States Food and Drug Administration (FDA) Division of
Cardiovascular and Renal Products. The purpose of the meeting was to discuss
the appropriate regulatory pathway for filing a marketing application of
ATPace(TM) as an antiarrhythmic drug for the acute termination of paroxysmal
supraventricular tachycardia (PSVT).
Based on discussions held during the meeting and prior written
communications between Duska and the FDA, the Company believes that the FDA
would consider a New Drug Application (NDA) under section 505(b)(2) for
ATPace(TM) subject to additional clinical data to be furnished by the Company.
The 505(b)(2) NDA relies in part upon relevant published data obtained by
entities other than the Company.
Dr. James Kuo, Duska's Chairman and CEO, said, "I am pleased to report
that this meeting with the FDA was both positive and constructive. Together
with our CRO, Cato Research, Inc., we have already commenced activities aimed
at the generation of the supplemental data requested by the FDA. The 505(b)(2)
NDA filing provides an expedited route for potential approval of ATPace(TM),"
he added.
Dr. Amir Pelleg, Duska's President and Chief Scientific Officer, stated,
"It has been our goal to commercialize the first ATP-based drug in the United
States and I believe we are now much closer to attaining that goal as a result
of this meeting. Formulations of ATP, which is the active ingredient in
ATPace(TM), have been used for over 50 years in Europe in the treatment of
PSVT. I am confident that our drug would manifest a safety and efficacy
profile similar to that of the European formulations."
About ATPace(TM)
ATPace(TM) is Duska's investigational intravenous pharmaceutical
formulation of ATP for the acute treatment of paroxysmal supraventricular
tachycardia (PSVT). The bradycardic (heart rate slowing) effect of ATP, in
particular its transient blockade of atrio-ventricular nodal conduction, has
been shown in multiple published clinical studies to terminate re-entrant PSVT
involving the atrio-ventricular node.
About PSVT
PSVT (paroxysmal supraventricular tachycardia) is a rapid regular heart
rate originating in the atria. It has been estimated that there are 89,000
new cases per year in the United States alone. PSVT is one of the most common
cardiac arrhythmias.
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 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 the Company believes that the FDA
would consider a New Drug Application (NDA) under section 505(b)(2) for
ATPace(TM) subject to additional clinical data to be furnished by the Company.
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. 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.
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
