Thu, Jun. 30, 10:44 AM
- Intra-Cellular Therapeutics (ITCI +0.9%) completes enrollment in its second Phase 3 clinical trial, ITI-007-302, assessing lead product candidate ITI-007 for the treatment of schizophrenia.
- The double-blind, placebo- and active-controlled study randomized 696 patients 1:1:1:1 to receive one of four treatments: 20 mg or 60 mg of ITI-007, risperidone 4 mg (active control) or placebo. The primary endpoint is the change from baseline to day 42 as measured by Positive and Negative Syndrome Scale (PANSS) total score.
- The first Phase 3 study, completed last year, was successful.
- ITI-007 combines 5-HT2A serotonin receptor antagonism, dopamine receptor phosphoprotein modulation, glutamatergic modulation and serotonin reuptake inhibition in one drug
- Previously: Intra-Cellular Therapies lead product candidate successful in late-stage study; shares up 32% premarket (Sept. 16, 2015)
Tue, Jun. 28, 7:48 AM
- Intra-Cellular Therapeutics (NASDAQ:ITCI) commences a Phase 3 clinical trial, ITI-007-201, assessing lead product candidate ITI-007 for the treatment of agitation in patients with dementia, including Alzheimer's disease (AD).
- The double-blind, placebo-controlled study will randomize ~360 subjects 1:1 to receive a daily oral dose of 9 mg of ITI-007 or placebo for four weeks. The primary endpoint is the treatment effect compared to placebo as measured by a 37-item scale called Cohen-Mansfield Agitation Inventory - Community version (CMAI-C) which measures the ability of a drug to reduce the overall frequency of agitation symptoms, including aggressive behaviors.
- ITI-007 combines 5-HT2A serotonin receptor antagonism, dopamine receptor phosphoprotein modulation, glutamatergic modulation and serotonin reuptake inhibition in one drug.
- As many as 60% of AD sufferers experience agitation.
- ITI-007 is also under development for the treatment of bipolar depression and schizophrenia.
Thu, Apr. 28, 7:16 AM
Wed, Apr. 27, 5:30 PM
- AB, ABBV, ACOR, ADP, AEP, AET, AIT, ALKS, ALLE, ALXN, AME, APD, ASPS, AUO, AVT, AXTA, BC, BCOR, BG, BLL, BMS, BMY, BOFI, BWA, BWEN, BXLT, BZH, CAB, CAH, CBG, CCE, CELG, CHTR, CIT, CL, CLF, CLFD, CME, CMS, COMM, COP, COR, CRCM, CRI, CRR, CSH, CVI, CVRR, CWT, CY, DBD, DFT, DLX, DNKN, DOW, DPZ, EME, EPD, EQM, EQT, F, FCFS, FCN, GEO, GLOP, GNC, GOV, GTLS, GWR, HAR, HEES, HHS, HMC, HUN, I, IDA, IDCC, INGR, INSY, INT, IPGP, IQNT, IRDM, IRM, ITC, ITCI, IVC, IVZ, KERX, LANC, LBY, LKQ, LVLT, MA, MD, MDP, MHO, MINI, MITK, MJN, MMC, MO, MPC, MPLX, MSCI, MTH, NEE, NEWM, NOV, OAK, ODFL, ORI, OSK, PF, PJC, POT, PPL, PRLB, PTEN, QSR, RGS, RTIX, RTN, RUTH, SABR, SCG, SEE, SFE, SIRI, SNAK, SNE, SPB, SPIL, SQNS, TFX, THRM, TMO, TOWR, TPX, TWC, TZOO, UAN, UBSI, UFS, UPS, UTHR, VA, VAC, VC, VIAB, VIVO, WCC, WM, WNS, WST, XRS, YNDX, ZBH
Thu, Feb. 25, 7:10 AM
Fri, Jan. 15, 5:40 PM
Dec. 23, 2015, 11:06 AM
- Intra-Cellular Therapies (ITCI +0.3%) commences two Phase 3 clinical trials, ITI-007-401 Monotherapy and ITI-007-402 Adjunctive Therapy to Lithium or Valproate, assessing lead product candidate ITI-007 in patients with bipolar depression.
- Each study will enroll ~550 subjects with Bipolar I or Bipolar II disorder who are experiencing a current major depressive episode. In the Monotherapy trial, patients will be randomized 1:1:1 to receive 40 mg ITI-007, 60 mg ITI-007 or placebo once daily orally for six weeks. In the Adjunctive trial, patients will receive ITI-007 or placebo adjunctive to their existing mood stabilizer lithium or valproate.
- The primary endpoint for both studies is the change from baseline at day 42 in the total score from a 10-item checklist (Montgomery-Asberg Depression Rating Scale) versus placebo. The individual items are rated by a clinician on a scale of 0 to 6.
- According to clinicaltrials.gov, the estimated completion date for the Monotherapy trial and the Adjunctive trial is December 2017.
- ITI-007 is a 5-HT2A serotonin receptor antagonist. Depressed patients have more 5-HT2A receptors than normal patients.
Nov. 5, 2015, 7:20 AM
- Intra-Cellular Therapies (NASDAQ:ITCI): Q3 EPS of -$0.91 misses by $0.21.
Sep. 21, 2015, 5:40 PM
Sep. 21, 2015, 4:45 PM
- Intra-Cellular Therapies (NASDAQ:ITCI) announces that it is assuming sponsorship of the clinical studies supporting ITI-214's IND for schizophrenia, after licensee Takeda Pharmaceutical (OTCPK:TKPHF) (OTCPK:TKPYY) apparently declined to proceed with development. Intra-Cellular is evaluating ITI-214 for several indications including cognition in patients with Parkinson's disease, dementia. schizophrenia and other disorders.
- ITI-214 inhibits an enzyme called phosphodiesterase type 1 (PDE1), which plays a key role in the regulation of multiple physiological processes. Inhibiting PDE1 inhibits the metabolism of the secondary messengers cAMP and cGMP thereby prolonging their effect in cell signaling.
- ITCI shares are unchanged in after hours trading.
Sep. 21, 2015, 4:04 PM
- Intra-Cellular Therapies (NASDAQ:ITCI) commences a $300M public offering of common stock. Price, volume and terms have yet to be announced.
Sep. 17, 2015, 9:15 AM
Sep. 16, 2015, 12:45 PM
Sep. 16, 2015, 9:12 AM
Sep. 16, 2015, 7:31 AM
- Thinly traded Intra-Cellular Therapies (NASDAQ:ITCI) is up 32% premarket on increased volume in response to its announcement of positive results for its lead product candidate, ITI-007, in a Phase 3 clinical trial in 450 patients with schizophrenia. A once-daily dose of 60 mg met the primary endpoint and demonstrated statistically significant antipsychotic efficacy versus placebo.
- Study participants were randomized 1:1:1 to receive either ITI-007 60 mg or 40 mg or placebo once daily for four weeks. Patients were diagnosed with schizophrenia (DSM-5 criteria) and were required to have an acute exacerbation of psychotic symptoms. The primary efficacy endpoint was the change from baseline at week 4 in PANSS total score (symptom severity) versus placebo. Participants had a mean PANSS score of 89.8 at baseline (very ill). A key secondary endpoint was CGI-S, also a measure of symptom severity.
- The 60 mg cohort showed a statistically significant improvement in PANSS score versus placebo (p=0.022), but the 40 mg cohort did not (p=0.164). Both doses demonstrated statistically significant improvement over placebo on the CGI-S (p=0.003 and p=0.025, respectively), although the 40 mg could not be formally compared to placebo since it did not achieve the primary endpoint. The 60 mg group also showed a statistically significant improvement in social functioning as measured by the Personal and Social Performance Scale (PSP).
- ITI-007 was well tolerated and showed a safety profile similar to placebo. Notable was the lack of difference in weight gain compared to placebo, a typical consequence of taking antipsychotic medications.
- The company intends to present the results at a future medical conference.
- Management will host a conference call this morning at 8:30 am ET to discuss the data.
Aug. 5, 2015, 7:17 AM
- Intra-Cellular Therapies (NASDAQ:ITCI): Q2 EPS of -$0.61 beats by $0.11.
- Revenue of $0.06M (-72.7% Y/Y) beats by $0.02M.
Intra-Cellular Therapies, Inc. is a biopharmaceutical company, which focuses on the discovery and clinical development of innovative, small molecule drugs that address underserved medical needs in neuropsychiatric and neurological disorders by targeting intracellular signaling mechanisms within... More
Industry: Drug Manufacturers - Major
Country: United States
Other News & PR