Duska Therapeutics Plans 505(b) (2) NDA Filing Route for ATPace(TM)
25/04/2008 09:03
PR Newswire
LA JOLLA, California, April 25 /PRNewswire/ --
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.
Web site: http://www.duskatherpeutics.com
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