Source: BUSINESS WIRE
Thursday, November 19, 2009
NEWTON, Mass.--(BUSINESS WIRE)--Clinical
Data, Inc. (NASDAQ: CLDA) today announced that it has enrolled the
first patient in its initial Phase III trial of Stedivaze™, a potential
best-in-class vasodilator for use in cardiac stress testing. The study
will evaluate the safety and efficacy of Stedivaze (apadenoson) for use
as a pharmacologic stress agent in myocardial perfusion imaging (MPI), a
method for detecting defects in the blood supply to the heart. The Phase
III trial will also compare the tolerability of Stedivaze to adenosine,
a standard pharmacologic stress agent used in MPI scans.
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“The superior selectivity and pharmacokinetic profile of Stedivaze
support its potential for improved tolerability compared to adenosine,
as seen in Phase II studies,” said Carol R. Reed, M.D., Executive Vice
President and Chief Medical Officer of Clinical Data. “Our Phase III
trial is designed to demonstrate that these attributes, combined with a
convenient, fixed, single-dose bolus administration, may offer the
best-in-class pharmacologic agent for use in cardiac stress testing.”
The Phase III ASPECT Trial (Apadenoson Single Photo Emission
Computed Tomography) is a randomized, double blind, active
control study designed to determine whether Stedivaze is as effective as
adenosine when used as a pharmacologic stress agent in SPECT MPI
studies. Approximately 750 patients will be enrolled over an 18 to 24
month period at investigative sites in the U.S. Patients in the study
will first undergo a clinically indicated SPECT MPI and then be
randomized to receive a second SPECT MPI using either adenosine or
Stedivaze. The incidence and severity of commonly reported side effects,
such as shortness of breath, chest pain, dizziness, and headache, will
also be evaluated to determine whether Stedivaze exhibits improved
tolerability compared to adenosine.
About Stedivaze
Stedivaze (apadenoson) is a potent agonist of the adenosine A2A
receptor subtype and offers improved selectivity over other
adenosine receptor subtypes (A1 and A2B). Phase II
studies suggest that Stedivaze produces ample coronary vasodilatory
activity needed for cardiac stress MPI and has a pharmacokinetic profile
that will allow it to be administered as a fixed dose bolus injection.
Because of its improved selectivity for the A2A receptor
subtype and its optimal pharmacokinetic profile, Stedivaze may offer
improved tolerability over other adenosine receptor agonists currently
marketed for use in pharmacologic stress MPI. Stedivaze is in Phase III
clinical development for use as a pharmacologic agent for myocardial
perfusion imaging with the goals of demonstrating equal efficacy and
improved tolerability compared to adenosine.
About Myocardial Perfusion Imaging
Myocardial perfusion imaging is used as a primary screen to identify the
presence of coronary artery disease (CAD) as evidenced by detection of
areas of poor blood flow in the heart that can be caused by the
formation of plaques that block the normal flow of blood to the heart. A
pharmacologic stress agent is used to increase blood flow through
coronary arteries temporarily during stress testing in order to more
strikingly define areas of the heart that receive poor blood flow. The A2A
adenosine receptor is the receptor subtype responsible for coronary
vasodilation, or the widening of blood vessels.1
The U.S market for MPI testing is projected to be $800 million. Over 7.6
million MPI tests were performed in the United States in 2008 and
approximately 3.5 million of these tests required the use of a
pharmacological agent to generate maximum coronary blood flow in lieu of
exercise.2 The market is expected to continue to grow due to
an increasing aging population, a rise in the number of patients unable
to perform exercise during diagnostic procedures, and emerging imaging
modalities that require the use of a vasodilator.
About Clinical Data, Inc.
Clinical Data develops first-in-class and best-in-category therapeutics.
The Company is advancing its late-stage drug candidates for central
nervous system disorders and cardiovascular
diseases, to be followed by promising drug candidates in other major
therapeutic areas. Clinical Data is also combining its drug development
and biomarker expertise to develop products with enhanced efficacy and
tolerability to improve patient health and reduce costs. To learn more,
please visit the Company's website at www.clda.com.
SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM
ACT OF 1995
This press release contains certain forward-looking information and
statements that are intended to be covered by the safe harbor for
forward looking statements provided by the Private Securities Litigation
Reform Act of 1995. Forward-looking statements are statements that are
not historical facts. Words such as "expect(s)", "feel(s)",
"believe(s)", "will", "may", "anticipate(s)" and similar expressions are
intended to identify forward-looking statements. These statements
include, but are not limited to, statements about our ability to obtain
regulatory approval for, and successfully introduce our new products;
our ability to expand our long-term business opportunities; financial
projections and estimates and their underlying assumptions; and all
other statements regarding future performance. All such
information and statements are subject to certain risks and
uncertainties, the effects of which are difficult to predict and
generally beyond the control of the Company, that could cause actual
results to differ materially from those expressed in, or implied or
projected by, the forward-looking information and statements. These
risks and uncertainties include, but are not limited to, risks related
to whether Stedivaze or any of our therapeutic products will advance
further in the clinical trials process and whether and when, if at all,
they will receive final approval from the U.S. Food and Drug
Administration and equivalent foreign regulatory agencies and for which
indications; whether Stedivaze or any of our other therapeutic products
will be successfully marketed if approved; the development of and our
ability to take advantage of the market for pharmacogenetic and
biomarker products and services; and those risks identified and
discussed by Clinical Data in its filings with the U.S. Securities and
Exchange Commission. Readers are cautioned not to place undue reliance
on these forward looking statements that speak only as of the date
hereof. Clinical Data does not undertake any obligation to
republish revised forward-looking statements to reflect events or
circumstances after the date hereof or to reflect the occurrence of
unanticipated events. Readers are also urged to carefully review and
consider the various disclosures in Clinical Data's SEC periodic and
interim reports, including but not limited to its Annual Report on Form
10-K for the fiscal year ended March 31, 2009, Quarterly Report on Form
10-Q for the fiscal quarter ended September 30, 2009, and Current
Reports on Form 8-K filed from time to time by the Company.
1Shryock, J.C., Snowdy, S., Baraldi, P.G., et al., “A2A
– adenosine Receptor Reserve for Coronary Vasodilation,” Circulation,
1998, pp. 711-718.
2AMR Monthly Monitor SNM: Advanced Molecular Imaging and
Therapy, September 15, 2008.