Company Encouraged by Investigator Report of Significant Decrease in Symptoms in First Patient in One Week
BEVERLY, MA–(Marketwired – July 18, 2016) - Cellceutix Corporation, (OTCQB: CTIX) (“the Company”), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, antibiotic, and anti-inflammatory applications, is pleased to provide additional information in the ongoing, open-label Phase 2 Proof-of-Concept (P-o-C) trial of Brilacidin for the treatment of ulcerative proctitis (UP) or ulcerative proctosigmoiditis (UPS). Brilacidin is being evaluated in adults with active, mild to moderate UP or UPS present for at least three months prior to screening with disease extending at least five centimeters, but no further than 40 centimeters from the anal verge, as confirmed by sigmoidoscopic examination.
Cellceutix has been advised that the first patient in Cohort A remains on study. The clinical site administering Brilacidin to this patient has informed the Company, “Both the patient and the site staff have been amazed how the study drug works as all the symptoms decreased significantly within the 1st week of treatment.”
While impressed and optimistic about the initial feedback, Cellceutix needs to strongly caution that this is limited feedback from only the first patient in the trial and the initial results may not be durable for the patient or indicative of future outcomes in the study.
“The trial being structured as an open-label study lets us know with certainty that Brilacidin was administered to the patient and not a placebo,” commented Dr. Arthur P. Bertolino, President and Chief Medical Officer at Cellceutix. “It’s still very early in the study, but this is the type of investigator feedback that is encouraging to hear. While by no means guaranteeing future results, it lends validation to laboratory research that suggested Brilacidin could provide a clinically meaningful therapeutic benefit for patients with UP, UPS and other inflammatory diseases and conditions. We are hopeful that the initial data will translate to durable and repeated results throughout the first cohort and subjects at higher dosing levels to align us for larger trials in the future.”
Cellceutix considers this early study information important as the Company has made a significant investment in studying the anti-inflammatory and immunomodulatory properties of Brilacidin for several different indications. Due to the pathogenesis of UP and UPS, Cellceutix views this data as strongly encouraging evidence of the anti-inflammatory and immunomodulatory properties of Brilacidin in the clinical setting. The data are pertinent with respect to not only inflammatory bowel conditions, but also to the ongoing, double-blind Phase 2 trial of Brilacidin-OM, where the combination of these properties is expected to deliver a clinical benefit to prevent and treat oral mucositis in patients receiving chemoradiation for head and neck cancer.
UP/UPS Trial Design
The primary objective of the P-o-C trial is to assess the frequency of clinical and endoscopic remission with Brilacidin administered per rectum in subjects with active UP or UPS after 6 weeks of treatment. Secondary objectives include evaluation of safety and tolerability of Brilacidin when administered per rectum, evaluation of clinical remission at Week 2 and Week 4, assessment of systemic exposure and/or pharmacokinetics of Brilacidin when administered per rectum, assessment of the efficiency of Brilacidin by biomarker evaluation of biopsy samples for interleukin (IL)-6 and IL-1beta, and estimation of statistical power for subsequent trial(s) in UP and UPS.
The P-o-C trial will include 18 patients divided evenly into three cohorts. Cohort A is receiving 50 milligrams (mg) of Brilacidin once daily for 42 days. Dosing will be increased to 100mg and 200mg once daily for 42 days for Cohort B and Cohort C, respectively. 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). Per protocol, a safety committee will review safety and retention data (clinical laboratory findings, vital signs and adverse events) after 21 days of therapy for all six patients in each cohort before proceeding with initiating enrollment in the subsequent cohort.