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

NEW YORK, July 29 /PRNewswire/ — Intra-Cellular
Therapies, Inc. today announced the results from a Phase Ib/II
clinical trial in patients with schizophrenia with ITI-007, the
Company’s unique, investigational new drug for the treatment of
schizophrenia.  The trial met its primary endpoint
demonstrating that ITI-007 was safe and well-tolerated in patients
with stabilized schizophrenia.  In addition, several
exploratory endpoints were evaluated. Treatment with ITI-007
yielded important clinical signs consistent with antipsychotic and
antidepressant efficacy including a reduction in the total Positive
and Negative Syndrome Scale (PANSS) and the Calgary Depression
Scale for Schizophrenia (CDSS). These results establish a firm
basis for selecting an active dose range for future efficacy trials
of ITI-007 in the treatment of patients with acutely exacerbated
schizophrenia.

“New and safer drugs are needed to treat the broad spectrum of
symptoms seen in patients with schizophrenia.  ITI-007
represents an exciting new drug with the potential to treat many of
the symptoms that accompany schizophrenia, some of which have been
previously unaddressed,” said Carol
Tamminga, M.D., Professor of Psychiatry at the University of Texas, UT Southwestern Medical
Center and leader in the field of schizophrenia research.
 “Given the novel pharmacology of ITI-007, the potential
exists to treat different symptoms by simple dose adjustments as
the symptoms of schizophrenia wax and wane over time. Future
clinical trials will be designed to extend these initial findings
and to demonstrate the unique characteristics of ITI-007.”

“We are pleased to have demonstrated such an excellent safety
profile of ITI-007 in our target patient population.  The
demonstration of clinic

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