Neurogen Announces Completion of Phase IA Study with ADCI for Epilepsy
Oct 27 1997 9:26AM CST, PRNewswireBRANFORD, Conn., Oct. 27 /PRNewswire/
-- Neurogen Corporation (Nasdaq: NRGN) today announced the completion of
a Phase IA study of ADCI, Neurogen's compound to treat epilepsy which is
licensed to Wyeth-Ayerst Laboratories, a division of American Home
Products (NYSE: AHP).
The Phase I study, conducted by Wyeth-Ayerst in human volunteers in
France, found ADCI to be safe and well-tolerated across a broad dose
range, with an acceptable pharmacokinetic profile.
In the placebo-controlled, escalating dose study, human volunteers
received either a single dose of ADCI or a placebo, with each successive
group receiving a higher dose. Importantly, this Phase I study indicates
that ADCI possesses acceptable pharmacokinetics and the necessary safety
profile needed for continued clinical development.
"We are very pleased that Wyeth-Ayerst was able to demonstrate safety
and test the pharmacokinetics of ADCI in humans so quickly," said Harry
H. Penner, Neurogen's President and CEO. "We look forward to the filing
of an IND and additional Phase I testing of ADCI by Wyeth-Ayerst in the
United States in the spring."
ADCI is a mild NMDA antagonist and a use-dependent blocker of voltage-
gated sodium channels, the combined effect of which in pre-clinical
studies is improved efficacy in the treatment of epileptic seizures.
Neurogen in-licensed ADCI from the National Institutes of Health in
1992, and subsequently out-licensed the compound to American Home
Products in November 1996.
Neurogen is a leading neuropharmaceutical company engaged in the design
and development of a new generation of drugs promising improved
treatment for a broad variety of neuropsychiatric disorders, including
anxiety, obesity, schizophrenia, sleep disorders, stress-related
disorders, dementia, depression, and epilepsy. Neurogen develops new
drug candidates through the integration of cutting edge neurobiology,
medicinal chemistry and molecular biology with its AIDD(SM) (Accelerated
Intelligent Drug Design) program, a proprietary blend of combinatorial
chemistry with high throughput screening, robotics and informatics.
The information in this press release contains certain forward-looking
statements that involve risks and uncertainties as detailed from time to
time in Neurogen's SEC filings, including its most recent 10-K. Actual
results may differ materially from the statements made as a result of
various factors, including, but not limited to, risks associated with
the inherent uncertainty of Company research, difficulties or delays in
development, testing, regulatory approval, production and marketing of
any of the Company's drug candidates, adverse side effects or inadequate
therapeutic efficacy of the Company's drug candidates, advancements of
competitive products, dependence on corporate partners, sufficiency of
cash to fund the Company's planned operations and patent, product
liability and third party reimbursement risks associated with the
pharmaceutical industry.
This release is available on the Internet at www.neurogen.com SOURCE
Neurogen Corporation |
