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

of CNS drugs or drug candidates. Intra-Cellular Therapies uses this platform in its drug discovery and development efforts of proprietary compounds and also to evaluate in-licensing opportunities.

About ITI-007

ITI-007 is the Company's first-in-class dual 5-HT2A receptor antagonist/dopamine receptor protein phosphorylation modulator (DPPM) for the treatment of schizophrenia. ITI-007 has dual properties; it acts as a post- synaptic antagonist and as a pre-synaptic partial agonist. The combination of ITI-007's high-potency blockade of 5HT2A receptors and unique dopamine receptor activity should allow a personalized approach to patient treatment for schizophrenia by making it possible for the first time, to select a clinical dose capable of saturating 5-HT2A receptors while permitting the "dialing in" of an optimal amount of dopamine receptor modulation by simple dose adjustments using a single drug. The ability to optimize the level of dopamine receptor modulation holds promise for the reduction of psychotic symptoms without incurring high levels of dopamine antagonism that cause motor disturbances and other deleterious side effects. In addition, the wide separation of affinity at 5-HT2A and D2 receptors may allow for administration of the appropriate amount of dopamine modulation for antipsychotic maintenance therapy and the treatment of bipolar disorders.

ITI-007 has a low propensity to interact with receptors that mediate deleterious cardiovascular events, sedation, and rapid and significant weight gain.

ITI-007 currently is being evaluated in several Phase I studies examining safety and tolerability, and 5HT2A and D2 occupancy in normal healthy volunteers at doses that interact with both 5-HT2A and dopamine receptors.

About Intra-Cellular Therapies

Intra-Cellular Therapies, Inc. (ITI), is a biopharmaceutical company that is developing novel drugs for the treatment of diseases and disorders of the Central Nervous System (C
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SOURCE Intra-Cellular Therapies, Inc.
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