When your surveys kings of leon images marketing budget kings of rodeo devises is shrinking, your bottomline no longer must suffer the same fate.For additional information on Mid-Atlantic Freelance, visit them online at or contact them directly or (703) 647-9619.Contact:Mid-Atlantic Freelance, LLCOffice: (703) 647-9619Fax: (703) 651-5512 release was issued through eReleases(TM).For more information, visit Freelance, LLCMid-Atlantic Freelance, LLC, +1-703-647-9619, Fax: +1-703-651-5512,. Intra-Cellular Therapies Announces Successful Outcome of a Phase II ClinicalTrial with ITI-007 in Patients with Sleep Maintenance Insomnia”Trial Concluded Early Due to Achievement of Statistical SignificanceDemonstrated at the Primary Endpoint”NEW YORK, Jan 13 /PRNewswire/ — Intra-Cellular Therapies, Inc. todayannounced successful top-line efficacy results for ITI-007 from a Phase IItrial in Insomnia characterized by difficulty in maintaining sleep, also knownas sleep maintenance insomnia (SMI).These data demonstrate that ITI-007 issafe and well-tolerated and demonstrate efficacy in reducing sleepdisturbances.ITI-007 is the Company’s first-in-class dual 5HT2A receptorantagonist/dopamine receptor phosphoprotein modulator (DPPM) for the treatmentof schizophrenia. A low dose formulation of ITI-007 (formerly referred to asITI-722) whose actions are predominantly mediated by 5HT2A receptor antagonismis being developed for the treatment of SMI.”The results that we have analyzed to date from this study are encouraging. Based on the robustness of the effects observed at the interim analysis, andafter extensive consultation with outside sleep experts, we have decided toconclude this phase of the trial for ITI-007 ahead of time with only half ofthe planned enrollment,” stated Sharon Mates, Chief Executive Officer ofIntra-Cellular Therapies.”We are now moving forward with an analysis of allother outcome measures and look forward to the continued development ofITI-007 in patients who suffer from Primary or comorbid Insomnia. Furthermore, these data serve to demonstrate the potential of ITI-007 as anext generation antipsychotic and treatment for sleep disorders in variouspatient populations including depression, bipolar disorder, Alzheimer’sdisease, mild cognitive impairment and other neuropsychiatric andneurodegenerative disorders where there is clear unmet medical need.”SUMMARY OF PHASE II SMI RESULTSITI-007 is an orally available drug candidate being evaluated at low doses inpatients with SMI.
An interim analysis (N=18 patients) was conducted for keyendpoints half-way through the initially planned enrollment of this study.When compared to placebo, patients treated with ITI-007 demonstrateddose-dependent increases in slow wave sleep (SWS) and robust decreases in wakeafter sleep onset (WASO) as measured by polysomnography (PSG) These outcomesmet the predefined objectives of the study kings of leon night . This Phase II trial was a double-blind, placebo controlled, 4-way crossoverdesign comparing placebo to 3 doses of ITI-007 in patients with SMI of leon kings . Analysisof key therapeutic endpoints in this study indicated that ITI-007dose-dependently and significantly increased SWS (p=0.002) and decreased WASO(p=0.032) over a wide range of doses aha shake heartbreak . Importantly this robust decrease in WASOwas reflected in increases in total sleep time The effects on sleep persistedthroughout the night youth and young manhood . Doses of ITI-007 were safe and well-tolerated, and werenot associated with any safety concerns.PHASE II RESULTS FOR ITI-007 Dose-ResponseOutcome Measure Trend Analysis(n=18)Mean Change from Baseline (min) p-valueITI-007Placebo 1 mg 5 mg10 mgWASO -1.86-18.47-14.31-33.22p = 0.032SWS-3.751 Kings Of Leon .115.538.94p = 0.002The effects of ITI-007 on WASO and SWS are likely due to the ability ofITI-007 to potently antagonize 5HT2A receptors at low doses (as low as 1 mg)and due to the expanded pharmacological effects that emerge as higher doseswere tested. The magnitude of these effects is larger than that seen withother drugs of this class and may be attributed to additional beneficialpharmacology that emerges at the higher doses tested. At the highest dosetested (10 mg) we expect to have full occupancy of 5HT2A receptors whileadding incremental amounts of D2 receptor and serotonin reuptake transporter(SERT) occupancy.
This has been confirmed in an ongoing human PositronEmission Tomography (PET) study where we have demonstrated that this dose isassociated with measurable brain dopamine D2 receptor occupancy (see below) kings of leon home . These robust decreases in WASO suggest that ITI-007 will have utility intreating not only SMI, but also other disorders associated with fragmentedsleep including many neuropsychiatric (e.g kingsofleon . major depression, bipolardisorder, PTSD, mild cognitive impairment and schizophrenia) and neurologicaldiseases (e Kings Of Leon – wikipedia .g Parkinson’s and Alzheimer’s diseases) because of the times . Furthermore, increasesin SWS are thought to be a biomarker for 5HT2A receptor occupancy and aspredicted from preclinical data, low doses of ITI-007 appear to occupy 5HT2Abrain receptors and increase SWS kings of rodeo . These data provide a firm base forprojecting the expected efficacious dose range for ITI-007 as this drug isadvanced in future studies for several indications, including SMI, sleepdisorders in depression and other psychiatric disorders, and schizophrenia.HIGHLIGHTS FROM PHASE I STUDIESIn separate Phase I single and multiple dose studies, ITI-007 was found to besafe and generally well-tolerated and was associated with dose proportionalincreases in plasma drug level. In ongoing human PET studies using a doserange studied in the Phase I and II studies (1-30 mg), ITI-007 was shown toproduce dose-dependent and therapeutically relevant increases in dopamine D2receptor occupancy in human brain.
These Phase I studies indicate this drug issafe and generally well-tolerated . To date more than 75 people have beenexposed to ITI-007 Kings Of Leon concert tickets – myspace .ABOUT SLEEP MAINTENANCE DISORDERSFrom insomnia to sleep apnea, sleep disorders disrupt the sleep of millions ofpeople all over the world.In particular, about 20% to 30% of the U.S.population complains of waking up frequently during the night or too earlyseveral times a week, symptoms of SMI that are characterized by difficultystaying asleep and unrefreshing sleep.In many populations (e.g of leon kings Kings Of Leon tickets . theelderly), the majority of sleep complaints are related to SMI rather thansleep initiation or difficulty in falling asleep.In addition, this type ofsleep disruption is common in patients with depression, bipolar disorder andother mood disorders, Alzheimer’s disease (AD) and neurological disorders aha shake heartbreak . Forexample, sleep disturbances in patients with Alzheimer’s disease is one of theprimary reasons that persons with AD are institutionalized . There is asignificant need for sleep medications that improve sleep quality in patientswith neuropsychiatric and neurologic disorders and comorbid sleep disorders.ABOUT ITI-007ITI-007 is the Company’s first-in-class dual 5HT2A receptorantagonist/dopamine receptor phosphoprotein modulator (DPPM) for the treatmentof schizophrenia.
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