BRISTOL, Tenn., Sept. 4 /PRNewswire-FirstCall/ -- King Pharmaceuticals,
Inc. (NYSE: KG) announced today that five abstracts featuring data from the
Phase I and Phase II clinical studies involving binodenoson, an adenosine A2A
receptor agonist that the Company is developing for cardiac pharmacologic
stress-imaging, are to be presented at the American Society of Nuclear
Cardiology ("ASNC") meeting being held in Indianapolis, Indiana, on
September 11-14, 2003. Four of the accepted abstracts will be featured as
poster presentations on Thursday, September 11th from 5:00 p.m. to 7:00 p.m.
These presentations include the following:
SPECT Image Concordance Between the New Selective Adenosine A2A Receptor
Agonist, Binodenoson, and Adenosine: A Multicenter, Randomized, Dose-Selection
Trial;
Discriminating Patient Tolerability of a New Selective Adenosine A2A
Receptor Agonist, Binodenoson, From Adenosine With a Visual Analog Scale
(VAS);
Risk Of Adverse Events From a Pharmacologic Stress SPECT Study for a New
Selective Adenosine A2A Receptor Agonist, Binodenoson Compared to Adenosine;
and
Pharmacokinetics and Safety of MRE-0470 Following Intravenous Dose
Escalation in Healthy Volunteers.
A fifth abstract, entitled "A Multi-Center, Randomized, Controlled Study
of the Safety and Efficacy of the Selective Adenosine A2A Receptor Agonist
Binodenoson for Pharmacologic Stress as an Adjunct to Myocardial Perfusion
Imaging," will be presented on Sunday, September 14 from 10:30 a.m. to
12:30 p.m. at the "Late Breaking Clinical Trials in Nuclear Cardiology"
session of the ASNC meeting.
Three of the poster presentations and the presentation at the Late
Breaking Clinical Trials in Nuclear Cardiology session will report in detail
the results of MRE0470P-206, a Phase II, multi-center, randomized, single-
blind, two-arm crossover dose-selection study that enrolled 240 patients with
high pretest likelihood for coronary artery disease ("CAD") or known and
symptomatic CAD. All patients underwent, in random sequence, a standard
pharmacologic stress test with adenosine, and a second, single-blind,
pharmacologic stress test with one of four randomly selected doses of
binodenoson. Safety, tolerability, and pharmacologic stress image concordance
comparisons between binodenoson and adenosine were examined. There was good
to excellent image concordance with all four binodenoson doses and adenosine.
Patients reported fewer and less severe side effects, including chest pain,
shortness of breath, and flushing during the binodenoson procedure than they
did during the adenosine procedure. None of the patients experienced A-V
block with binodenoson, compared to an incidence of 3% with adenosine. The
incidence and the intensity of side effect reductions using binodenoson were
dose-related. The fourth poster presentation reports on the safety and
pharmacokinetic results of escalating-dose infusions of binodenoson that were
obtained in a Phase I study in healthy human volunteers.
Richard J. Barrett, Ph.D., Senior Director of Clinical Research for King,
stated "The data from our Phase I and Phase II trials with binodenoson are
very encouraging. These results are being utilized in the planning of the
protocols for two pivotal Phase III trials involving binodenoson, the first of
which is anticipated to begin during the fourth quarter of this year."
Dr. Barrett observed, "Approximately 3 million pharmacologic stress tests
are performed in the United States each year to diagnose heart disease in
patients who cannot perform traditional exercise stress tests. Adenosine and
dipyridamole are the current agents of choice to achieve the coronary
vasodilation necessary for cardiac imaging in the United States, but these
drugs do not distinguish between the four subtypes of adenosine receptors. By
targeting the adenosine A2A receptor subtype, binodenoson appears to detect
myocardial ischemia as well as adenosine, while minimizing side effects like
heart block, dyspnea and chest pain."
King, headquartered in Bristol, Tennessee, is a vertically integrated
pharmaceutical company that develops, manufactures, markets, and sells branded
prescription pharmaceutical products. King, an S&P 500 Index company, seeks
to capitalize on opportunities in the pharmaceutical industry through the
development, including through in-licensing arrangements and acquisitions, of
novel branded prescription pharmaceutical products in attractive markets and
the strategic acquisition of branded products that can benefit from focused
promotion and marketing and product life-cycle management.
This release contains forward-looking statements, which reflect
management's current views of future events and operations, including, but not
limited to, statements pertaining to the Phase III trial involving binodenoson
that is anticipated to begin during the fourth quarter of 2003; and the
effectiveness of binodenoson. These forward-looking statements involve
certain significant risks and uncertainties, and actual results may differ
materially from the forward-looking statements. Some important factors which
may cause results to differ include: dependence on King's ability to timely
initiate the Phase III trial involving binodenoson scheduled to begin during
the fourth quarter of 2003; dependence on the continued successful development
of binodenoson; dependence on the unpredictability of the duration and results
of the U.S. Food and Drug Administration ("FDA") review of any Investigational
New Drug Application and New Drug Application relating to binodenoson;
dependence on our compliance with FDA and other government regulations that
relate to our business; and dependence on changes in general economic and
business conditions; changes in federal and state laws and regulations; and
manufacturing capacity constraints. Other important factors that may cause
actual results to differ materially from the forward-looking statements are
discussed in the "Risk Factors" section and other sections of King's Form 10-K
for the year ended December 31, 2002 and Form 10-Q for the second quarter
ended June 30, 2003, which are on file with the SEC. King does not undertake
to publicly update or revise any of its forward-looking statements even if
experience or future changes show that the indicated results or events will
not be realized.
SOURCE King Pharmaceuticals, Inc.
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http://www.kingpharm.com
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CONTACT:
James E. Green, Executive Vice President,
Corporate Affairs of King Pharmaceuticals, Inc., +1-423-989-8125
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