Cellceutix Completes Patient Enrollment of Final Cohort in Phase 2 Trial of Brilacidin for Inflammatory Bowel Disease; Topline Results Anticipated in July

BEVERLY, MA – May 18, 2017 (GLOBE NEWSWIRE) Cellceutix Corporation, (OTCQB:CTIX) (“the Company”), is pleased to announce that patient enrollment has been completed in the third and final cohort of its Phase 2 open-label, Proof-of-Concept (PoC) clinical trial evaluating Brilacidin as a novel, non-corticosteroid, non-biologic treatment for mild-to-moderate Ulcerative Proctitis / Ulcerative Proctosigmoiditis (UP/UPS), two types of Inflammatory Bowel Disease (IBD).

Study Overview

In this Phase 2 PoC trial, a total of 17 patients across three sequentially recruited cohorts will have enrolled to receive Brilacidin once daily administered per rectum as a retention enema for 42 days (6 weeks) of treatment. Cohort A (6 patients) and Cohort B (6 patients) have already completed treatment, receiving 50 milligrams (mg) and 100 mg of Brilacidin, respectively. Cohort C (5 patients) currently is in progress, with patients receiving 200 mg once daily. For all patients, endoscopic evaluation of the rectum and mucosa up to 40 cm from the anal verge will be performed at screening and at the end of treatment/Day 42 (± 3 days), with scoring performed by both trial investigators and independent gastroenterologists. The Primary Efficacy Endpoint of the Brilacidin UP/UPS trial uses Modified Mayo Disease Activity Index (MMDAI) scoring, a common measurement tool in managing Ulcerative Colitis preferred by many IBD specialists, to determine Clinical Remission at Day 42. Secondary Efficacy Endpoints include: change in MMDAI score, both Full and Partial, and; change in patient Quality of Life as assessed by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ).

Management Comments

Based on results observed in the first two cohorts of patients who completed treatment, Brilacidin showed strong signs of efficacy while being well-tolerated, reinforcing its potential to become a novel, non-corticosteroid, non-biologic anti-inflammatory drug candidate. The third and final cohort has been limited to five patients—instead of six—and will ensure that the most robust data set for this trial remains on schedule for presentation at the Drug Discovery & Therapy World Congress in July.

“What is perhaps most remarkable about this trial is that Brilacidin was administered to patients in water as a retention enema,” said Leo Ehrlich, Chief Executive Officer at Cellceutix. “The logical next step is transitioning to a foam and gel/lotion formulation, with planning already underway, which would greatly facilitate Brilacidin’s adhesion to the mucosal lining of the gastrointestinal tract and may lead to even greater efficacy. Brilacidin for UP/UPS is well-positioned to become first-in-class.”

“We expect that a complete body of data and evidence, including importantly endoscopic evaluation, will demonstrate just how safe and effective Brilacidin, as an emerging treatment, might one day become for those suffering from a wide range of debilitating inflammatory bowel conditions,” said Cellceutix’s President and Chief Medical Officer, Arthur P. Bertolino, MD, PHD, MBA. The Company expects treatment of the final Brilacidin UP/UPS cohort to be completed in June, with topline interim results across all cohorts to be presented at the Drug Discovery & Therapy World Congress in Boston, MA July 10-13, 2017.

For reference, previously released detailed interim findings from the Brilacidin UP/UPS trial are available at the following link: