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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

al signals across a broad spectrum of exploratory efficacy measures is also encouraging, especially considering that these patients had clinically stable symptoms at study entry," stated Sharon Mates, Chief Executive Officer of Intra-Cellular Therapies.  "We believe that the favorable clinical profile is consistent with ITI-007's unique pharmacology."

SUMMARY OF ITI-007 PHASE IB/II STUDY RESULTS

The Phase Ib/II study was a randomized, double-blind, placebo-controlled, multiple ascending dose study designed to evaluate the safety, tolerability and pharmacokinetic profile of ITI-007 in patients with stable schizophrenia.  Exploratory endpoints included clinical assessments to evaluate the symptoms of schizophrenia (PANSS) and symptoms of depression (CDSS).  Forty-five patients were randomized to receive ITI-007 or placebo once daily for five days.  Oral doses of ITI-007 up to and including 140 mg were found to be safe and well-tolerated with repeated administration in patients with stable schizophrenia who had been withdrawn from their previous antipsychotic medications.  In an earlier Phase II sleep efficacy trial, low doses of 1-10 mg ITI-007 were shown to significantly improve sleep in patients with insomnia.  In the present study, patients with schizophrenia also anecdotally reported improvements in sleep.  Even at the highest doses of ITI-007 tested, all adverse events were mild to moderate.  Notably, there were no extrapyramidal side effects (EPS) and no cognitive impairment, side effects that are often observed following treatment with other antipsychotic drugs at high doses.  Total cholesterol and triglyceride levels decreased following withdrawal from previous antipsychotic drugs and while being treated with ITI-007.  Pharmacokinetic profiles suggest a once-a-day treatment regimen will be sufficient to achieve
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SOURCE Intra-Cellular Therapies, Inc.
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