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Wed, Jul. 22, 4:58 PM
- Following communications with the FDA, Intra-Cellular Therapies (NASDAQ:ITCI) plans to commence two Phase 3 clinical trials later this year assessing its lead product candidate, ITI-007, for the treatment of depressive episodes associated with bipolar disorder. Both will be randomized, double-blinded and placebo-controlled.
- The first Phase 3 will evaluate ITI-007 as monotherapy while the second Phase 3 will assess ITI-007 as adjunctive therapy.
- ITI-007 is a 5-HT2A serotonin receptor antagonist. Depressed patients have more 5-HT2A receptors than normal patients.
Tue, Jun. 23, 11:07 AM
- Intra-Cellular Therapies (ITCI +3.7%) initiates enrollment in a second Phase 3 trial (ITI-007-302) assessing its lead product candidate, ITI-007, in patients with an acutely exacerbated episode of schizophrenia. The treatment period is six weeks. The primary endpoint is the change from baseline at Day 42 in the PANSS total score (Positive And Negative Syndrome Scale). Top-line results are expected in 2016.
- Enrollment in the first Phase 3, ITI-007-301, was completed earlier this month. Top-line data are expected in H2.
- In low doses, ITI-007 acts as a 5-HT2A serotonin receptor antagonist. At higher doses, it also modulates dopamine receptors and inhibits serotonin transporters.
Mon, May 18, 8:47 AM
- At the American Psychiatric Association meeting in Toronto, Intra-Cellular Therapies (NASDAQ:ITCI) presented additional data from a 335-subject Phase 2 clinical trial evaluating its lead product candidate, ITI-007, in patients with schizophrenia.
- The study met its primary efficacy endpoint of a statistically significant improvement in psychosis as measured by the change from baseline at day 28 in PANSS total score versus placebo.
- Patients in the intent-to-treat population who received once-daily 60 mg ITI-007 showed improved negative symptoms as did a subgroup of those with prominent negative symptoms. The effects were not observed in patients treated with risperidone (branded version: Janssen Pharmaceuticals' (NYSE:JNJ) Risperdol). Also, a subgroup of schizophrenia patients who had co-morbid depression that were treated with ITI-007 showed a statistically significant anti-psychotic effect not observed in the risperidone cohort.
- Treatment with ITI-007 demonstrated a favorable tolerability profile with little or no weight gain, favorable effect on metabolic measures and a reduced risk of akathisia (feeling of restlessness) and hyperprolactinemia (elevated prolactin in the blood which may cause breast enlargement in men).
- ITI-007 is currently in Phase 3 development.
- ITCI is up 5% premarket on light volume.
Thu, May 7, 12:09 PM
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Intra-Cellular Therapies, Inc. is a biopharmaceutical company. The Company is engaged in discovery and clinical development ofsmall molecule drugs that address underserved medical needs in neuropsychiatric and neurological disorders.
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