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Intra-Cellular Therapies Announces Upcoming Presentations on ITI-007 at the American Psychiatric Association 167th Annual Meeting, the Society of Biological Psychiatry 69th Annual Meeting, and the International Review of Psychosis & Bipolarity Annual Meeti

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NEW YORK, April 30, 2014 (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 that several presentations related to ITI-007, the Company's lead product candidate, will be featured at the following meetings:

  • American Psychiatric Association's (APA) 167th Annual Meeting, to be held May 3-7, 2014, in New York, NY;
  • Society of Biological Psychiatry (SOBP) 69th Annual Meeting, to be held May 8-10, 2014, in New York, NY; and
  • International Review of Psychosis & Bipolarity (IRPB) Annual Meeting, to be held May 9-12, 2014, in Athens, Greece.

APA Presentations

Jeffrey A. Lieberman, M.D., President, American Psychiatric Association; Lawrence C. Kolb Professor and Chairman of Psychiatry at the Columbia University College of Physicians and Surgeons, and Director of the New York State Psychiatric Institute, will present data from ITI-007-005, the Company's recently completed Phase 2 clinical trial in patients with an acutely exacerbated episode of schizophrenia. The oral presentation will be held during the session "New Treatments for Mental Disorders: Focus on Schizophrenia and OCD" on Wednesday, May 7 from 9:00 A.M. to 10:30 A.M. EDT. Location: Jacob K. Javits Convention Center of New York; Room 1E08, Level 1.

Poster NR8-173: "ITI-007 for the Treatment of Schizophrenia: A Randomized, Double-Blind, Placebo- and Active-Controlled Phase 2 Trial". Kimberly E. Vanover, et al. To be presented on Tuesday, May 6 from 2:30 P.M. to 4:00 P.M. EDT. Location: Javits Convention Center; Halls 3A/3B, Level 3.

SOBP Presentations

Poster #409: "Mechanism of Action of ITI-007: Serotonergic, Dopaminergic and Glutamatergic Modulation". Gretchen L. Snyder, et al. To be presented on Thursday, May 8 from 5:00 P.M. to 6:30 P.M. EDT. Location: New York Hilton Midtown hotel; Americas Hall I - 3rd Floor.

Poster #1161: "ITI-007 for the Treatment of Schizophrenia: A Differentiating Response Profile". Kimberly E. Vanover, et al. To be presented on Saturday, May 10 from 5:00 P.M. to 6:30 P.M. EDT. Location: New York Hilton Midtown; Americas Hall I - 3rd Floor.

IRPB Presentation

Oral presentation: "ITI-007, a New Approach to the Treatment of Multiple Domains in Schizophrenia: Improvement in Social Function". To be presented on Friday, May 9 at 3:30 P.M. Local Time. Location: Divani Caravel Hotel.

"We believe the upcoming presentations provide a more comprehensive understanding of the profile of ITI-007 and provide evidence for the benefit of ITI-007 as a potential stand-alone therapy for the treatment of the acute and chronic phases of schizophrenia," said Sharon Mates, Ph.D., Chief Executive Officer and Chairman of Intra-Cellular Therapies. "We look forward to continuing the development of ITI-007 for the treatment of schizophrenia, bipolar disorder, behavioral disturbances in dementia and other indications."

About Intra-Cellular Therapies

Intra-Cellular Therapies (the "Company") is developing novel drugs for the treatment of neuropsychiatric and neurodegenerative disease and other disorders of the central nervous system ("CNS"). The Company is developing its lead drug candidate, ITI-007, for the treatment of schizophrenia, behavioral disturbances in dementia, bipolar disorder and other neuropsychiatric and neurological disorders. In December 2013, the Company announced positive topline results from the Company's randomized, placebo- and active-controlled Phase II clinical trial of ITI-007 in patients with acutely exacerbated schizophrenia. This study showed a statistically significant improvement in symptoms associated with schizophrenia at the 60 mg dose on the trial's pre-specified primary endpoint and a favorable safety profile. The Company is also utilizing its phosphodiesterase (PDE) platform and other proprietary chemistry platforms to develop drugs for the treatment of cognitive deficits in schizophrenia and other CNS disorders. The Company has partnered its lead PDE1 compound, ITI-214, and backups from this platform with the Takeda Pharmaceutical Company. ITI-214 has finished the first Phase 1 clinical trial and is now in subsequent Phase 1 trials. The Company is also developing inhibitors against additional targets for CNS indications such as Alzheimer's disease, Parkinson's disease and depression and non-CNS indications such as cardiovascular disease.

Forward-Looking Statements

This news release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding, among other things, our belief that the upcoming presentations will provide a more comprehensive understanding of the profile of ITI-007 and provide evidence for the benefit of ITI-007 as a potential stand-alone therapy for the treatment of the acute and chronic phases of schizophrenia; and our plans for continuing the development of ITI-007 for the treatment of schizophrenia, bipolar disorder, behavioral disturbances in dementia and other indications. All such forward-looking statements are based on management's present expectations and are subject to certain factors, risks and uncertainties that may cause actual results, outcome of events, timing and performance to differ materially from those expressed or implied by such statements. These risks and uncertainties include, but are not limited to the following: our current and planned clinical trials for ITI-007 and our other product candidates may not be successful or may take longer and be more costly than anticipated; product candidates that appeared promising in earlier research and clinical trials may not demonstrate safety and/or efficacy in larger-scale or later clinical trials; our reliance on collaborative partners and other third-parties for development and commercialization of our product candidates; and the other risk factors discussed under the heading "Risk Factors" contained in our Annual Report on Form 10-K for the year ended December 31, 2013 filed with the Securities and Exchange Commission (SEC), as well as any updates to those risk factors filed from time to time in our periodic and current reports. All statements contained in this press release are made only as of the date of this press release, and we do not intend to update this information unless required by law.

CONTACT: Juan Sanchez, M.D. Vice President Corporate Communications and Investor Relations of Intra-Cellular Therapies, Inc. 212-923-3344 Burns McClellan, Inc. Lisa Burns/Angeli Kolhatkar (Investors) Justin Jackson (Media) jjackson@burnsmc.com 212-213-0006

Source:Intra-Cellular Therapies, Inc.