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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

'Trial Meets Primary and Key Secondary Endpoints'

NEW YORK, March 10 /PRNewswire/ -- Intra-Cellular Therapies, Inc. today announced the final results from the ITI-007 Phase II trial in patients with Sleep Maintenance Insomnia (SMI). In this study, ITI-007 significantly and dose-dependently increased slow wave sleep and decreased the duration of wake after sleep onset as measured by polysomnography (PSG), meeting the prespecified primary and key secondary endpoints of the trial. ITI-007 also increased total sleep time and sleep efficiency. PSG improvements such as increased total sleep time and slow wave sleep are associated with reports of improved sleep quality. Improvement in these sleep parameters is driven by the unique pharmacology of ITI-007 that can act simultaneously as a 5HT2A receptor antagonist, dopamine receptor phosphoprotein modulator (DPPM), and inhibitor of serotonin reuptake. These additional actions clearly differentiate ITI-007 from other sleep modulating drugs. The present Phase II data suggest the beneficial effects on sleep are a result of ITI-007's distinctive neuropharmacological mechanisms beyond simple 5HT2A receptor antagonism. As such, ITI-007 represents a novel approach for the treatment of insomnia characterized by difficulty in staying asleep, as well as for the treatment of insomnia related to psychiatric and neurologic disorders. These clinical results will be presented at a major scientific meeting in June.

"We are excited to have demonstrated ITI-007's ability to produce such robust improvements on sleep quality," stated Sharon Mates, Chief Executive Officer of Intra-Cellular Therapies. "We believe that the positive effects on sleep in this study are a result of ITI-007's unique pharmacological profile that clearly differentiate it from currently available sleep inducing or sleep maintaining drugs. These data set the stage for further investigation of ITI-007's ability to improve slee
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SOURCE Intra-Cellular Therapies, Inc.
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