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.
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CONTACT: Duska Therapeutics, Inc.
James S. Kuo, M.D., M.B.A., Chairman and CEO
858.551.5700
Fax: 858.551.5704
kuoj@duskascientific.com
470 Nautilus Street, Suite 300
La Jolla, CA 92037
