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Cellceutix Releases Preliminary Efficacy and Safety Data in Interim Analysis of First Two Cohorts in Phase 2 Trial of Brilacidin for the Induction of Remission of Mild-to-Moderate Ulcerative Colitis
Cellceutix Releases Preliminary Efficacy and Safety Data in Interim Analysis of First Two Cohorts in Phase 2 Trial of Brilacidin for the Induction of Remission of Mild-to-Moderate Ulcerative Colitis.
About this update from Innovation Pharmaceuticals Inc.
[{"type":"text","content":"\n\n BEVERLY, Mass., March 08, 2017 (GLOBE NEWSWIRE) -- Cellceutix Corporation, (OTCQB:CTIX) (“the Company”), a clinical stage biopharmaceutical company developing innovative therapies with dermatology, oncology, anti-inflammatory, and antibiotic applications, today announced interim results in the first two cohorts of its ongoing Phase 2a clinical trial of Brilacidin for the induction of remission of mild-to-moderate Ulcerative Colitis. Patient recruitment to the third cohort (highest dose) is currently underway. Patients include those with Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS), two types of Inflammatory Bowel Disease (IBD).\n The ongoing Phase 2, open-label, Proof-of-Concept (PoC) trial comprises three sequential cohorts (6 patients per cohort), with progressive dose escalation by cohort—50 mg (Cohort A), 100 mg (Cohort B), and 200 mg (Cohort C), respectively. Daily treatment with Brilacidin by enema administration is performed consecutively for 42 days. All twelve (12) patients across the first two cohorts have completed their full dosing schedules in the study. Comparison to baseline after six weeks of treatment showed: All 12 patients experienced a beneficial response, as measured by the Modified Mayo Disease Activity Index (MMDAI).-- At Day 42, the Primary Efficacy Endpoint of Clinical Remission (accounting for Stool Frequency, Rectal Bleeding, and Endoscopy sub-scores), was met in half (n=6) of all patients (3 of 6 in Cohort A; 3 of 6 in Cohort B).-- Among the remaining patients (n=6) in Cohorts A and B not meeting all three criteria for Clinical Remission, two of the three criteria were achieved by all of these patients (defined as a Partial Response).Patient Quality-of-Life, as assessed by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ), was improved in all 12 patients after six weeks of daily Brilacidin treatment. Specifically, over 40 percent of patients reported significant improvements, ranging approximately from 20 points to more than 50 points higher on the 70-point SIBDQ scale.Brilacidin was generally well-tolerated and patients maintained stable normal vital signs during treatment. Measurements of drug concentrations in plasma continued to show limited systemic absorption of Brilacidin, with all values registering less than 100 ng/mL for all six patients in Cohor...