Duska Therapeutics,
Inc. (OTC Bulletin Board: DSKA) ("Duska") announced that it has
received comments from the U.S. Food and Drug Administration's (the "FDA")
Division of Cardiovascular and Renal Products on a synopsis of a proposed
Phase 3 clinical study with its lead drug, ATPace(TM), for the acute
treatment of a frequent cardiac arrhythmia called paroxysmal
supraventricular tachycardia (PSVT).
On April 16, 2008, Duska met with the FDA and confirmed that a New Drug
Application under section 505(b)(2) would be the appropriate regulatory
pathway for filing an ATPace marketing application for the acute treatment
of PSVT. Duska is in the process of modifying the proposed Phase 3 clinical
trial in accordance with the FDA's comments it received and plans to submit
a revised protocol to the FDA for Special Protocol Assessment procedure
approval. Duska intends to initiate a single, prospective,
placebo-controlled, and randomized trial in patients presenting to the
emergency room with PSVT to demonstrate ATPace's clinical safety and
efficacy. Upon successful completion, Duska intends to file a New Drug
Application under section 505(b)(2).
Dr. Amir Pelleg, Duska's President and Chief Scientific Officer,
stated, "I believe that the comments of the FDA on our proposed design of a
pivotal Phase 3 clinical trial with ATPace are constructive and will allow
us to move expeditiously forward in the development of this proposed drug
for the acute treatment of PSVT."
ATPace, adenosine triphosphate injection, is a proposed drug for the
termination of PSVT. The bradycardic effect of adenosine triphosphate, in
particular its blockade of atrio-ventricular nodal conduction, has been
shown in multiple published clinical studies to safely and effectively
terminate re-entrant PSVT involving the atrio-ventricular node.
PSVT, one of the most common cardiac arrhythmias, 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 and approximately 570,000 persons overall
with PSVT in the United States alone.
Currently, adenosine is the only approved treatment for PSVT in the
U.S. Duska believes that the initial dose of ATPace will be significantly
more efficacious than the initial labeled dose of adenosine in terminating
PSVT. While both adenosine triphosphate and adenosine inhibit
atrio-ventricular nodal conduction, adenosine triphosphate is believed to
have dual inhibitory action; one mediated by adenosine, the product of its
rapid enzymatic degradation, and the other, a triggered vagal reflex. Vagal
maneuvers aimed at enhancing vagal tone to the heart, and thereby
suppressing atrio-ventricular nodal conduction, have been clinically used
to terminate tachycardia. Injectable formulations of adenosine triphosphate
have been approved in Europe for over 50 years as safe and efficacious
treatments for PSVT. Duska has established its own safety database for
ATPace, which was obtained in its Phase 1 and 2 clinical trials, and has
obtained more than 1,000 patients records from other clinical trials.
About Duska Therapeutics, Inc.
Duska Therapeutics, Inc. (Duska) is a specialty pharmaceutical company
that develops new cardiovascular 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 duskatherapeutics.
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 plans to submit the revised Phase 3 clinical trial to the FDA
for Special Protocol Assessment (SPA) procedure approval, Duska believes
that the initial dose of ATPace(TM) will be significantly more efficacious
than the initial labeled dose of adenosine in terminating PSVT, ATP is
believed to have dual inhibitory action; one mediated by adenosine, the
product of its rapid enzymatic degradation, and the other, a triggered
vagal reflex, Duska intends to initiate a single, prospective,
placebo-controlled, and randomized trial in patients presenting to the
emergency room with PSVT to demonstrate ATPace's clinical safety and
efficacy, Duska intends to file a New Drug Application under section
505(b)(2), Dr. Amir Pelleg believes that the comments of the FDA on our
proposed design of a pivotal Phase 3 clinical trial with ATPace are
constructive and will allow us to move expeditiously forward in the
development of this proposed drug for the acute treatment of PSVT, Duska's
ATPace(TM) is expected to enter a pivotal Phase 3 clinical trial for the
treatment of paroxysmal supraventricular tachycardia and Duska's CDP-1050
is expected to commence a Phase 2 clinical trial for the treatment of heart
failure. 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 revised protocol may not receive procedural
approval, 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, the
NDA may be rejected and we may never successfully commercialize ATPace(TM)
or CDP-1050. 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 sec. 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.
Duska Therapeutics, Inc.
duskatherapeutics