Intra-Cellular Therapies, Inc., a biopharmaceutical company, develops novel drugs for the treatment of neuropsychiatric and neurologic diseases, and other disorders of the central nervous system (CNS). Its lead product candidate, ITI-007, which is in clinical development for the treatment of exacerbated and residual schizophrenia; bipolar disorders; sleep deficits associated with neurologic and psychiatric disorders; behavioral disturbances associated with dementia, including Alzheimer’s disease; sleep maintenance insomnia; major depressive disorders; and autism spectrum disorders, posttraumatic stress disorder, and intermittent explosive disorder. The company also develops ITI-002 phosphodi...
New York, NY 10032
Intra-Cellular Therapies, Inc. Presents at 7th Annual 2014 Deutsche Bank BioFEST, Dec-01-2014
Dec 1 14
Intra-Cellular Therapies, Inc. Presents at 7th Annual 2014 Deutsche Bank BioFEST, Dec-01-2014 . Venue: Four Seasons Hotel Boston, 200 Boylston Street, Boston, MA 02116, United States. Speakers: Sharon Mates, Co-Founder, Chairman, Chief Executive Officer and President.
Intra-Cellular Therapies, Inc. Announces Enrollment of First Patient in Phase 3 Trial of ITI-007 for the Treatment of Schizophrenia
Nov 25 14
Intra-Cellular Therapies, Inc. announced that the first patient has been enrolled in the ITI-007-301 Phase 3 trial, a randomized, double-blind, placebo-controlled trial designed to demonstrate the efficacy of ITI-007 for the treatment of schizophrenia. The company anticipates top-line results from this trial could be available as early as the fourth quarter of 2015. The company expects to initiate a second ITI-007 Phase 3 trial in schizophrenia, designated as the ITI-007-302 trial, in the first half of 2015. In December 2013, the company announced positive results from a Phase 2 trial in which ITI-007 exhibited antipsychotic efficacy with a favorable safety profile in patients with schizophrenia. About the ITI-007-301 Phase 3 Trial: The ITI-007-301 clinical trial is a randomized, double-blind, placebo-controlled Phase 3 trial designed to determine the safety and efficacy of ITI-007 for the treatment of schizophrenia. Over 400 patients with an acutely exacerbated episode of schizophrenia are planned to be randomized to receive one of three treatments: 60 mg ITI-007, 40 mg ITI-007, or placebo in a 1:1:1 ratio. Patients will receive study treatment orally once daily in the morning for 28 days. The primary endpoint for this clinical trial is change from baseline to Day 28 on the Positive and Negative Syndrome Scale (PANSS) total score. The PANSS is a well-validated 30-item rating scale that measures the ability of a drug to reduce schizophrenia symptom severity (Kay et al., 1987, Schizophrenia Bulletin 13:261-276). The PANSS measures positive symptoms, such as delusions, suspiciousness, and hallucinations; negative symptoms, such as blunted affect, social and emotional withdrawal, and stereotyped thinking; and general psychopathology, such as anxiety, tension, depression, and active social avoidance. Secondary endpoints include subscales of the PANSS and other measures to highlight key differentiating features of ITI-007. Safety and tolerability also will be assessed. About ITI-007: ITI-007 is lead drug development candidate, whose mechanisms of action, The company believes, have the potential to yield a first-in-class antipsychotic therapy. In pre-clinical and clinical trials to date, ITI-007 combines potent serotonin 5-HT2A receptor antagonism, dopamine receptor phosphoprotein modulation (DPPM), glutamatergic modulation and serotonin reuptake inhibition into a single drug candidate for the treatment of acute and residual schizophrenia. At dopamine D2 receptors, ITI-007 has been demonstrated to have dual properties and to act as both a post-synaptic antagonist and a pre-synaptic partial agonist. ITI-007 has also been demonstrated to stimulate phosphorylation of glutamatergic NMDA NR2B, or GluN2B, receptors in a mesolimbic specific manner. The company believes that this regional selectivity in brain areas thought to mediate the efficacy of antipsychotic drugs, together with serotonergic, glutamatergic, and dopaminergic interactions, may result in antipsychotic efficacy for positive, negative, affective and cognitive symptoms associated with schizophrenia. The serotonin reuptake inhibition could allow for antidepressant activity for the treatment of schizoaffective disorder, co-morbid depression, and/or as a stand-alone treatment for major depressive disorder. The company believes ITI-007 may also be useful for the treatment of bipolar disorder and other psychiatric and neurodegenerative disorders, particularly behavioral disturbances associated with dementia, autism and other CNS diseases.
Intra-Cellular Therapies, Inc. Announces Additional Results from Phase I/II Clinical Trial in Healthy Geriatric Subjects and Patients with Dementia
Nov 21 14
Intra-Cellular Therapies, Inc. presented additional results from ITI-007-200, a Phase I/II clinical trial designed to evaluate the safety, tolerability and pharmacokinetics of low doses of its lead drug candidate, ITI-007, in healthy geriatric subjects (trial Part 1) and in patients with dementia, including Alzheimer's disease (trial Part 2). Secondary endpoints explored the effects of ITI-007 on measures of cognitive function. The additional data showing clinical signals for ITI-007 to improve cognition are being presented at the Clinical Trials on Alzheimer's Disease (CTAD) conference being held in Philadelphia, Nov. 20-22. This trial marks an important milestone in the expansion of the company's CNS platform. The ITI-007-200 trial results to date indicate that ITI-007 is safe and well-tolerated across a range of low doses, has linear- and dose-related pharmacokinetics and improves cognition in the elderly. These results further position the drug as a development candidate for the treatment of behavioral disturbances in patients with dementia and other neuropsychiatric and neurological conditions. The Company plans to initiate a Phase 2 clinical program evaluating ITI-007 in patients with behavioral disturbances associated with dementia and related disorders, including Alzheimer's disease, in 2015.