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Intra-Cellular Therapies Reports Positive Final Results of a Phase II Clinical Trial with ITI-007 in Patients with Sleep Maintenance Insomnia
Date:3/10/2009

pproach to patient treatment for schizophrenia by making it possible for the first time, to select a clinical dose capable of saturating 5HT2A 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 5HT2A 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.

The present data show that ITI-007 is sleep promoting without having sedative properties and should not exhibit adverse effects during the night (e.g. falls, amnesia) or next day hangover effects that are commonly associated with other sleep medications. ITI-007 is expected to have a strong safety profile with no addiction liability. This compound is being evaluated for the treatment of sleep disorders in various patient populations with sleep maintenance problems and in other sleep disorders such as sleep disorders in depression, other mood disorders, Alzheimer's disease and schizophrenia.

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 on the science generated from the Nobel Prize winning laboratory of Dr. Paul Greengard at The Rockefeller University, the Company develops compounds that have the potential to treat a wide r
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