Cellceutix Phase 2 Brilacidin Trial Progresses to Highest Dose Cohort for the Induction of Remission of Mild-to-Moderate Ulcerative Colitis
BEVERLY, Mass., Feb. 22, 2017 -- Cellceutix Corporation, (OTCQB:CTIX) (“the Company”), a clinical stage biopharmaceutical company developing innovative therapies with dermatology, oncology, anti-inflammatory, and antibiotic applications, today announced progression of its ongoing Phase 2 clinical trial of Brilacidin to the third cohort (highest dose) for induction of remission of mild-to-moderate ulcerative colitis after satisfactory safety of prior cohorts was reported by the study’s Safety Committee. Patients included those with Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS), two types of Inflammatory Bowel Disease (IBD).
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.
Patients continued to tolerate the treatment well in Cohort B, echoing comments from patients in Cohort A by reporting improvements in quality of life. Even with the dose doubling from the first cohort (50 mg) to 100 mg, drug concentrations in plasma remained in a favorable range, averaging 200 ng/mL maximum concentrations across the six patients in Cohort B.
Efficacy data are currently being analyzed and patients for Cohort C (200 mg group) are now being enrolled.
