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Cellceutix Phase 2 Trial Initial Data Shows Potential of Brilacidin as a Novel Anti-Inflammatory Drug Candidate for the Induction of Remission of Mild-to-Moderate Ulcerative Colitis
Cellceutix Phase 2 Trial Initial Data Shows Potential of Brilacidin as a Novel Anti-Inflammatory Drug Candidate 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., Oct. 10, 2016 (GLOBE NEWSWIRE) -- Cellceutix Corporation, (OTC: CTIX) (“the Company”), a clinical stage biopharmaceutical company developing innovative therapies with dermatology, oncology, anti-inflammatory, and antibiotic applications, is pleased to announce today interim results observed for the first four patients treated with Brilacidin for Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS), a type of Inflammatory Bowel Disease (IBD). Clinically meaningful improvements were demonstrated, as measured by physician assessments, patient reported outcomes and endoscopic evaluation of disease activity.\n The ongoing Phase 2, open-label, proof-of-concept trial comprises three sequential cohorts (6 patients per cohort), with progressive dose escalation by cohort—50 mg, 100 mg, and 200 mg, respectively. Treatment with Brilacidin by daily enema administration is performed for 42 days. Four (4) of 6 patients to date in the lowest dosing cohort (50 mg) have completed the study. Comparison to baseline after 6 weeks of treatment showed: All 4 patients experienced a clinically meaningful response, as measured by the Modified Mayo Disease Activity Index (MMDAI). At Day 42, on the Partial MMDAI (accounting for Stool Frequency, Rectal Bleeding, and Physician’s Global Assessment scores), 2 of 4 patients achieved full response (100% reduction) and the other 2 patients had notable improvement (50% reduction).At Day 42, on the MMDAI (equivalent to Partial MMDAI + Endoscopy score; completed by 3 of 4 patients), 1 of 3 patients achieved full response (100% reduction) and 2 of 3 patients had notable improvement (50% reduction). One patient who had demonstrated a full response on the Partial MMDAI (as defined in first bullet point) did not consent to the final endoscopy, so their data cannot be included in these initial results. Patient quality of life, as assessed by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ), was improved after 6-weeks of treatment with Brilacidin.Brilacidin was generally well-tolerated and patients maintained stable normal vital signs during treatment. For all 4 patients, measurements of drug concentrations in plasma showed all levels, across all time points, to be below the lower limit of quantification (i.e., <100 ng/mL), which is consistent with very limit...