BRISTOL, Tenn., Dec. 11 /PRNewswire-FirstCall/ -- King Pharmaceuticals,
Inc. (NYSE: KG) announced today the commencement of the Phase I clinical trial
program for T-62, an investigational drug for the treatment of neuropathic
pain. The initial Phase I trial for T-62 is a single-center, randomized
double-blind, placebo-controlled evaluation of the safety and pharmacokinetics
of escalating single oral doses of this new chemical entity in healthy adult
subjects.
Michael K. Jolly, Pharm.D., Executive Vice President, Research and
Development, of King, stated, "The commencement of our Phase I clinical trial
program for T-62 represents an important step forward in providing patients
who suffer from neuropathic pain with the first orally-administered product in
a new class of investigational agents indicated for the treatment of this
prevalent condition. Neuropathic pain is a serious disorder that impacts the
lives of over 27 million people in the U.S. according to Datamonitor and there
is a substantial unmet medical need for more effective products to treat this
debilitating condition. We believe that T-62 should represent a significant
advancement in filling that need."
Dr. Jolly explained, "When given orally, T-62 enhances the effect of
endogenous adenosine in the spinal cord and should provide effective relief
for neuropathic pain by the same mechanism as intrathecally administered
adenosine. Adenosine, a neurotransmitter that affects the adenosine A1
receptors in the spinal cord to normalize the pain response, has been shown to
be an effective treatment for neuropathic pain when injected into the spinal
cord via intrathecal administration."
King, headquartered in Bristol, Tennessee, is a vertically integrated
branded pharmaceutical company. 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 development of T-62 as an effective
treatment for neuropathic pain. 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 the continued successful
development of T-62, including the results of the planned clinical trials
involving the compound that are intended to demonstrate its safety and
efficacy as a treatment for neuropathic pain; 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 T-62; dependence on the development of
competing products; 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 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 third quarter
ended September 30, 2003, which are on file with the U.S. Securities and
Exchange Commission. 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.
 back to top
Related links:
http://www.kingpharm.com
CONTACT:
James E. Green, Executive Vice President,
Corporate Affairs of King Pharmaceuticals, Inc., +1-423-989-8125
|
