LA JOLLA, Calif., July 23 /PRNewswire-FirstCall/ -- Duska Therapeutics,
Inc. (OTC Bulletin Board: DSKA) ("Duska") announced today that it has
submitted for comment a synopsis of a proposed Phase 3 clinical study for its
lead drug, ATPace(TM), to the U.S. Food and Drug Administration's (the "FDA")
Division of Cardiovascular and Renal Products.
Based on recent communications with the FDA, including a face-to-face
meeting held on April 16, 2008, Duska believes that the proposed single,
prospective, placebo-controlled, and randomized trial in patients presenting
to the emergency room with paroxysmal supraventricular tachycardia (PSVT)
should be sufficient to demonstrate clinical safety and efficacy. The proposed
primary endpoint of the study is dose-dependent conversion of PSVT to normal
sinus rhythm. The FDA has expressed willingness to review and comment on the
proposed trial design according to the Special Protocol Assessment (SPA)
procedure.
PSVT is a rapid regular heart rate originating in the atria. It has been
estimated that there are 89,000 new cases of PSVT per year in the United
States alone. PSVT is one of the most common cardiac arrhythmias.
Duska has already compiled clinical data on the safety and efficacy of
adenosine triphosphate (ATP), which is the active pharmaceutical ingredient in
ATPace(TM), in the treatment of patients with PSVT. In addition, Duska has its
own safety database on ATPace(TM), which was obtained in Phase 1 and 2
clinical trials. Based on these data, Duska believes that upon successful
completion of the proposed Phase 3 trial, it would have all the clinical data
necessary to support the filing of the NDA for ATPace(TM) under section
505(b)(2), the drafting of which has already commenced.
Dr. James Kuo, Duska's Chairman and CEO, said, "After our recent
interactions with the FDA, I believe we have a clear plan to acquire all the
data that would be necessary to support the filing of a NDA for ATPace(TM)
under Section 505(b)(2)".
Dr. Amir Pelleg, Duska's President and Chief Scientific Officer, stated,
"I expect that the Special Protocol Assessment by the FDA would facilitate the
completion of the clinical development of ATPace(TM) in a timely fashion".
About ATPace(TM)
ATPace(TM) (adenosine triphosphate injection) is a proposed product for
the termination of paroxysmal supraventricular tachycardia (PSVT). The
bradycardic effect of ATP, in particular its blockade of atrio-ventricular
nodal (AVN) conduction, has been shown to effectively terminate re-entrant
PSVT involving the AV node. Adenosine is the only approved competition in the
U.S. Duska believes that the initial dose of ATPace(TM) will be significantly
more efficacious than the initial labeled dose of adenosine in terminating
PSVT. While ATP and adenosine both inhibit AVN conduction, ATPace(TM) is
believed to have a second mechanism of action to stimulate vagally-mediated
suppression of AVN conduction. Injectable formulations of ATP have been
approved in Europe for over 50 years as safe and efficacious treatments for
PSVT. Duska has completed Phase 1 and 2 clinical trials in diagnosing
bradycardia, and has acquired more than 1,000 patients records from other
clinical trials. Duska has met with the FDA to ascertain which additional
requirements might be necessary for marketing approval of ATPace(TM). Duska
plans a 505(b)(2) NDA filing route for approval.
About Duska Therapeutics, Inc.
Duska Therapeutics, Inc. (Duska) is a specialty pharmaceutical company
that develops new cardiovascular and pulmonary medicines based upon the
emerging new pharmacology of adenosine triphosphate (ATP) and nitric oxide
(NO). These two molecules play critical roles in cellular metabolism and
signal transduction, the manipulation of which by several pharmaceuticals
constitute novel therapeutic modalities for the treatment of major
cardiovascular disorders. Duska is developing a portfolio of investigational
medicines, two of which are in late stages of clinical testing. Duska's
ATPace(TM) is expected to enter a pivotal Phase 3 clinical trial for the
treatment of paroxysmal supraventricular tachycardia. Duska's CDP-1050 is
expected to commence a Phase 2 clinical trial for the treatment of heart
failure. In addition, Duska has a preclinical program to develop new chemical
entities that target a newly discovered pathway in the pathophysiology of
chronic obstructive pulmonary disease. For more information, visit
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 Duska believes that the proposed
single, prospective, placebo-controlled, and randomized trial in patients
presenting to the emergency room with paroxysmal supraventricular tachycardia
(PSVT) should be sufficient to demonstrate clinical safety and efficacy, that
Duska believes that upon successful completion of the proposed Phase 3 trial,
it would have all the clinical data necessary to support the filing of the NDA
for ATPace(TM) under section 505(b)(2), the belief that Duska has a clear plan
to acquire all the data that would be necessary to support the filing of a NDA
for ATPace(TM) under Section 505(b)(2), and the expectation that the SPA by
the FDA will facilitate the completion of the clinical development of
ATPace(TM) in a timely fashion. 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. Such risks
include the risk that the FDA comments about the prospective clinical design
may not be favorable, that further clinical studies may be required prior to
filing the NDA, the anticipated SPA procedure may not be applied to the
proposed protocol, the clinical trial for approval of ATPace(TM) may not be
successful and that the NDA may be rejected. 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
