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Intra-Cellular Therapies Initiates Phase 2 Clinical Trial for Sleep Maintenance Insomnia
Date:12/20/2007

NEW YORK, Dec. 20 /PRNewswire/ -- Intra-Cellular Therapies, Inc. (ITI), today announced it has initiated a sleep maintenance insomnia (SMI) Phase 2 clinical study using its drug candidate ITI-722. ITI-722 acts predominantly as a selective 5-HT2A receptor antagonist and represents an important new approach to the treatment of SMI. Because of its novel separation of 5-HT2A and dopamine receptor modulatory activities, ITI believes, ITI-722 can be used not only to treat SMI but it may be highly appropriate for the treatment of sleep disorders that accompany neurodegenerative disorders, including Parkinson's disease and other psychiatric disorders.

"The progression of ITI-722 into Phase 2 for SMI represents the advancement of this important new class of therapeutics," stated Sharon Mates, Ph.D., Chairman and Chief Executive Officer of Intra-Cellular Therapies. "This drug candidate has therapeutic potential to treat SMI in the general population, and in other patient populations who have been underserved, particularly peri- and post-menopausal women, and in other disorders where insomnia is a problem, including osteoarthritis, depression, Parkinson's disease and other neurologic and psychiatric disorders."

The Phase 2 program is a multi-center, randomized, double-blind placebo- controlled study in patients with SMI. The primary endpoint is an assessment of objective slow wave sleep using polysomnography (PSG). Secondary endpoints include other objective and subjective measures of SMI and sleep efficiency. Additionally, the study will make an assessment regarding next-day cognitive performance.

ITI-722 is a low-dose formulation of ITI-007, ITI's first-in-class 5-HT2A antagonist/ dopamine receptor protein phosphorylation modulator (DPPM), presently in clinical trials for the treatment of schizophrenia.

About Sleep Maintenance Disorders

From nightmares to insomnia to sleep apnea, sleep disorders disrupt the sleep of millions of peopl
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SOURCE Intra-Cellular Therapies, Inc.
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