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Cellceutix Phase 2 Trial Dose Escalates in 2nd Cohort for Brilacidin as a Novel Anti-Inflammatory Drug Candidate for Ulcerative Colitis
Cellceutix Phase 2 Trial Dose Escalates in 2nd Cohort for Brilacidin as a Novel Anti-Inflammatory Drug Candidate for Ulcerative Colitis.
About this update from Innovation Pharmaceuticals Inc.
[{"type":"text","content":"\n\n BEVERLY, Mass., Dec. 07, 2016 (GLOBE NEWSWIRE) -- Cellceutix Corporation, (OTCQB:CTIX) (“the Company”), a clinical stage biopharmaceutical company developing innovative therapies with dermatology, oncology, anti-inflammatory, and antibiotic applications, is pleased to announce today initiation of the second cohort of patients treated with Brilacidin for Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS), two types of Inflammatory Bowel Disease (IBD).\n Review of safety data from the first cohort revealed that Brilacidin, administered for 6 weeks as a retention enema, at 50 mg once daily, appeared well-tolerated, with no measurable systemic absorption detected. This drug profile, at the lowest dose, allowed the approval of dose escalation to the second cohort (100 mg, once daily). Clinically meaningful improvements in symptoms of UP/UPS were also demonstrated in the first cohort, as measured by physician assessments and patient reported outcomes, further supported with endoscopic evaluation of disease activity. The ongoing Phase 2, open-label, proof-of-concept clinical trial is evaluating Brilacidin for induction of remission, not merely maintenance, in patients suffering from mild-to-moderate UP/UPS.  The trial comprises three sequential cohorts (6 patients per cohort), with progressive dose escalation by cohort—50 mg, 100 mg, and 200 mg Brilacidin, respectively. Treatment with Brilacidin by daily enema administration is performed consecutively for 42 days. “We remain extremely encouraged by the results that continue to emerge from this trial. In addition, the clinical sites at which the study is being performed are now even more enthusiastic about recruiting additional patients to the trial. Such enthusiasm is a good indicator of Brilacidin’s potential in treating ulcerative colitis and other inflammatory bowel diseases. We look forward to seeing data from the next cohorts,” said Arthur P. Bertolino, MD, PhD, MBA, Cellceutix President and Chief Medical Officer. Alerts: Sign-up for Cellceutix email alerts is available at: http://www.cellceutix.com/email-alerts About Brilacidin Brilacidin is Cellceutix’s lead drug candidate in its defensin mimetic franchise. Modeled after Host Defense Proteins (HDPs), the “front-line” of defense in the immune system, it is a ...