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Intra-Cellular Therapies Presents Additional Iti-007 Data At The 5Th Biennial Schizophrenia International Research Society (Sirs) Conference

The following excerpt is from the company's SEC filing.

NEW YORK, April 6, 2016/GLOBE NEWSWIRE/ Intra-Cellular Therapies, Inc. (NASDAQ: ITCI), a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders, today announced it delivered an oral presentation and presented several posters featuring data on ITI-007, the Companys lead drug candidate at the 5th Biennial Schizophrenia International Research Society (SIRS) Conference being held in Florence, Italy.

The oral presentation and two poster presentations featured additional efficacy and safety data from ITI-007-301, the Companys recently completed Phase 3 clinical trial in patients with schizophrenia. An additional poster presentation featured data from the ITI-007 Positron Emission Tomography (PET) study in patients with schizophrenia. Top-line data from both trials were announced in September 2015 and subsequently presented at the 54th annual meeting of the American College of Neuropsychopharmacology (ACNP) in December 2015.

Poster #S66 entitled ITI-007 Exhibits Unique Pharmacology: Combined Results from Positron Emission Tomography (PET) Studies in Healthy Volunteers and Patients with Schizophrenia, was presented on Sunday, April 3rd. This PET study highlights ITI-007s unique pharmacological profile via serotonergic, dopaminergic, and glutamatergic pathways. ITI-007 was safe and well-tolerated and demonstrated dose-related occupancy of human brain dopamine D

receptors, 5-HT

receptors, and serotonin transporters. At a dose of 60 mg, ITI-007 demonstrated relatively low, about 40% mean peak striatal D

receptor occupancy in patients with schizophrenia at plasma steady state. Taken into context with data from other clinical trials, ITI-007 60 mg was effective in reducing psychosis in patients with schizophrenia at relatively low striatal D

receptor occupancy, lower than the occupancy range required by most other antipsychotic drugs. This mechanism, along with ITI-007s potent interactions at 5-HT

receptors, serotonin transporters and D1 receptors, likely contributes to the efficacy of ITI-007 with improved psychosocial function and favorable motoric tolerability representing a potentially novel approach to the treatment of schizophrenia and other neuropsychiatric disorders.

Additional data regarding receptor occupancy within specific brain regions such as the ventral striatum were presented.

Poster #M67 entitled Positive Phase 3 Clinical Trial of ITI-007 for the Treatment of Schizophrenia: Secondary Endpoints and Subgroup Analyses from a Randomized, Double-Blind, Placebo-Controlled Trial, was presented on Monday, April 4

. In this trial, once-daily ITI-007 60 mg met the primary endpoint and demonstrated efficacy with statistically significant superiority over placebo at Day 28 as measured by the Positive and Negative Syndrome Scale (PANSS) total score (p=0.022). Moreover, ITI-007 60 mg showed significant efficacy as early as week 1 on both the PANSS total score and PANSS Positive Symptom subscale score, which was maintained at every time point throughout the entire study. ITI-007 60 mg also met the key secondary endpoint of statistically significant improvement on the Clinical Global Impression of Severity of Illness (CGI-S) (p=0.003). Both doses (ITI-007 40 mg and 60 mg) improved global severity of illness, positive symptoms and prosocial behavior.

A high treatment completion rate was observed with ITI-007 (87% of patients completed treatment on ITI-007 60 mg, 82% completed on ITI-007 40 mg, and 75% completed on placebo). Patients randomized to ITI-007 60 mg demonstrated a statistically significant longer time to treatment discontinuation due to any reason compared to placebo (p=0.006) and a statistically significant longer time to treatment discontinuation due to lack of efficacy (p=0.01). Baseline...


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