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Intra-Cellular Therapies Announces the Successful Completion of a Phase Ib/II Study of ITI-007 in Patients with Schizophrenia
Date:7/29/2010

w a personalized approach to patient treatment 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.  At low doses, ITI-007 improves sleep in patients suffering from insomnia characterized by difficulty maintaining sleep throughout the night, without producing daytime sedation.  In contrast to most other antipsychotic medications, ITI-007 is non-sedating, increasing sleep and decreasing wakefulness during the night with no daytime drowsiness or next-day hangover effects.  At higher doses, the ability to optimize the level of dopamine receptor modulation holds promise for the reduction of acute as well as chronic psychotic symptoms in patients with schizophrenia without incurring motor disturbances and other deleterious side effects. Importantly, ITI-007 also has a low propensity, much lower than currently marketed antipsychotic drugs, to bind receptors that mediate deleterious cardiovascular events, profound sedation and rapid and significant weight gain. 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 disorder, posttraumatic stress disorder, behavioral disturbances in Alzheimer's disease, and autism. The serotonin reuptake inhibition allows for additional antidepressant efficacy for the treatment of schizoaffective disorder, co-morbid depression, and/or as a stand-alone treatment for major depressive disorder (MDD).

ABOUT INTRA-CELLULAR THERAPIES

Intra-Cellular Therapies, Inc. (ITI) is a biopharmaceutical company developing novel drugs for the treatment of diseases and disorders of the Central Nervous System (CNS).  Building
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1. Intra-Cellular Therapies Announces the Results of a Phase I PET Study for ITI-007 for the Treatment of Schizophrenia and Other Psychiatric Disorders
2. Intra-Cellular Therapies Announces Successful Outcome of a Phase II Clinical Trial with ITI-007 in Patients with Sleep Maintenance Insomnia
3. Intra-Cellular Therapies Announces the Discovery of Potent Antidepressant Activity in ITI-007
4. Intra-Cellular Therapies Announces the Discovery of Potent Antidepressant Activity in ITI-007/ITI-722
5. Intra-Cellular Therapies Presents Data on Its Schizophrenia and Cognition in Schizophrenia Programs at the 14th Biennial Winter Workshop on Schizophrenia and Bipolar Disorders
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