суббота, 28 мая 2011 г.

Neurogen Commences Phase II Clinical Trial In Chronic Insomnia Patients

Neurogen Corporation
(Nasdaq: NRGN) today announced that it has commenced a Phase II clinical
trial in chronic insomnia patients with the Company's insomnia agent,
NG2-73. The study will measure reduction in time to onset of persistent
sleep and sleep maintenance across a range of doses and formulations during
two weeks of treatment. NG2-73 selectively modulates receptors of the
gamma-aminobutyric acid (GABA) neurotransmitter system and is one of
several unpartnered compounds in Neurogen's portfolio.



The Phase II clinical trial is a randomized, double-blind,
placebo-controlled, multi-center, parallel group study designed to
determine the efficacy and safety of five different dose and formulation
profiles of NG2-73 compared to placebo. The primary endpoint will be the
time it takes to fall asleep as defined by Latency to Persistent Sleep
(LPS). Sleep maintenance will be explored in several secondary endpoints.
At least 240 chronic insomniacs, aged up to 64 years, are expected to
receive study drug or placebo for 14 days. Polysomnography will be used to
measure various sleep parameters.



The study will test doses and formulations of NG2-73 which are expected
to span the therapeutic range. Doses to be tested include sustained release
formulations. The exposure/response relationships will also be examined and
pharmacokinetic/pharmacodynamic (PK/PD) modeling will be utilized to
facilitate dose and formulation optimization.



William H. Koster, President and CEO, said, "We are building on the
positive and highly significant results of our Phase II transient insomnia
study, where NG2-73 demonstrated dramatic improvement over placebo for LPS.
We now will seek to confirm the robust LPS response in chronic insomniacs
and begin to assess sleep maintenance, since insomniacs may suffer from
sleep initiation, sleep maintenance issues or both.



"Our target product profile for NG2-73 is a drug that provides quick
onset and reduces wake time through the night, with patients awakening
feeling refreshed and with no hangover effects. In order to expand and
intensify our knowledge of doses and formulations of NG2-73 for duration of
action, we plan to launch an additional concurrent study in insomniacs
later this year."



About Neurogen's Insomnia Program



Neurogen previously announced results from Phase II human testing in
transient insomnia for NG2-73. The primary endpoint of the study measured
the efficacy of NG2-73 in reducing time to onset of persistent sleep in a
well established clinical model of transient insomnia in healthy adults. In
the multi-center, 369 subject study, NG2-73 was shown to significantly
reduce time to onset of persistent sleep versus placebo at all doses
tested. NG2-73 was well-tolerated at all doses, with no drug-related
serious adverse events or drug-related premature subject withdrawals.
















Prescription drugs dominating the insomnia market work by modulating
the GABA-A system of neurotransmitters. GABA is a chemical naturally
released in certain parts of the brain in order to inhibit brain activity.
Preclinical studies suggest that NG2-73 is pharmacologically distinct from
currently marketed insomnia agents, as well as those in development. These
studies with NG2-73 compared to the other GABA hypnotic agents that are
potent agonists at multiple receptor subtypes, indicate that NG2-73 may
provide the benefit of sleep with a reduction in next day side effects.



Webcast



Neurogen will host a conference call and webcast to discuss this
announcement at 11:00 a.m. ET today, October 30, 2006. The webcast will be
available in the Investor Relations section of neurogen and
will be archived on the website until December 31, 2006. A replay of the
call will be available after 1:00 pm ET today and accessible through the
close of business November 20, 2006. To replay the conference call, dial
888-286-8010, or for international callers, 617-801-6888, and use the pass
code: 43091770.



About Neurogen Corporation



Neurogen Corporation is a drug discovery and development company
focusing on small molecule drugs to improve the lives of patients suffering
from disorders with significant unmet medical need, including insomnia,
pain, depression, and obesity. Neurogen has generated a portfolio of
compelling new drug candidates through its Accelerated Intelligent Drug
Discovery (AIDD(TM)) system, its expertise in cellular functional assays,
and its depth in medicinal chemistry. Neurogen conducts its research and
development independently and, when advantageous, collaborates with
world-class pharmaceutical companies.



Safe Harbor Statement



The information in this press release contains certain forward-looking
statements, made pursuant to applicable securities laws, that involve risks
and uncertainties as detailed from time to time in Neurogen's SEC filings,
including its most recent 10-K. Such forward-looking statements relate to
events or developments that we expect or anticipate will occur in the
future and include, but are not limited to, statements that are not
historical facts relating to the timing and occurrence of anticipated
clinical trials, and potential collaborations or extensions of existing
collaborations. Actual results may differ materially from such
forward-looking statements as a result of various factors, including, but
not limited to, risks associated with the inherent uncertainty of drug
research and development, 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 or
pharmacokinetic properties of the Company's drug candidates or other
properties of drug candidates which could make them unattractive for
commercialization, advancement of competitive products, dependence on
corporate partners, the Company's ability to retain key employees,
sufficiency of cash to fund the Company's planned operations and patent,
product liability and third party reimbursement risks associated with the
pharmaceutical industry. For such statements, Neurogen claims the
protection of applicable laws. Future results may also differ from
previously reported results. For example, positive results or safety and
tolerability in one clinical study provides no assurance that this will be
true in future studies. Neurogen disclaims any intent and does not assume
any obligation to update these forward-looking statements, other than as
may be required under applicable law.


Neurogen Corporation

neurogen

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