Cellceutix Completes Enrollment in Second of Three Planned Cohorts in Phase 2 Clinical Trial of Brilacidin for Inflammatory Bowel Disease

BEVERLY, MA – Jan. 17, 2017 (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 that enrollment has been completed in the second cohort of the Phase 2 open label Proof-of-Concept trial evaluating Brilacidin as a new treatment for mild-to-moderate ulcerative proctitis/ulcerative proctosigmoiditis, two types of inflammatory bowel disease.

In the trial, patients in the second cohort are being administered 100 mg of Brilacidin once daily as a retention enema for 42 consecutive days.  As such, Cellceutix expects treatment of the second cohort to be completed by the end of February.

Initial data from the first cohort, treated with 50 mg Brilacidin once daily showed the drug to be well-tolerated, with no measurable systemic absorption detected.  Clinically meaningful improvements in symptoms were documented through endoscopic evaluation, as well as physician assessments and patient reported outcomes.

“To date, the trial has exceeded our expectations on all fronts.  The study needs to be successfully completed with the final data fully analyzed, but at this point we attribute the early favorable results to Brilacidin’s robust anti-inflammatory therapeutic profile. Given Brilacidin’s unique mechanism of action, the body is able to get back to doing what it’s usually already good at—fighting illness and infection,” said Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Cellceutix.

Leo Ehrlich, Chief Executive Officer at Cellceutix commented, “We raised a lot of eyebrows at meetings at the Biotech Showcase conference last week and are capturing the attention of Big Pharma with preliminary reports and scopes. Seeing the before and after endoscopic videos from patients in Cohort 1 is the most encouraging support of Brilacidin’s potential for treating IBD. I am proud to say that to date, every patient in this trial has benefited from their Brilacidin treatment.” 

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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 small, non-peptidic, synthetic molecule that kills pathogens swiftly and thoroughly. Just as importantly, Brilacidin also functions in a robust immunomodulatory capacity, lessening inflammation and promoting healing. Due to its unique properties, Cellceutix is studying Brilacidin’s effect on oral mucositis (under Fast Track designation) and on ulcerative proctitis/proctosigmoiditis (UP/UPS) in Phase 2 trials. Additional trials of Brilacidin are planned in other conditions, including: hidradenitis suppurativa and acne. Brilacidin is also being developed under FDA’s Qualified Infectious Disease Product (QIDP) designation as an antibacterial product for Acute Bacterial Skin and Skin Structure Infection (ABSSSI)—qualifying it for Fast Track and possible Priority FDA Review and an extra 5 years of United States market exclusivity upon drug approval.

About UP/UPS

Ulcerative proctitis (UP), a limited type of ulcerative colitis (UC), is a mucosal inflammatory disease of unknown cause involving only the rectum. When it involves both the rectum and the distal colon, it is called Ulcerative Proctosigmoiditis (UPS). It is characterized by inflammation, redness, and ulcerations of the mucosa. The course of the disease is variable and ranges from complete resolution to easily maintained remission to chronic relapses or refractory disease. Diagnosis can occur at any point in life, with approximately 30-50 percent of patients developing more extensive UC. There is currently no cure. According to estimates provided by GlobalData, the worldwide UC market, which includes products for UP/UPS, is expected to increase at a compound annual growth rate of 4.7 percent, from $4.2 billion in 2012 to approximately $6.6 billion by 2022.

About Cellceutix’s Proof-of-Concept (PoC) UP/UPS Trial Design

This trial is being conducted in an overseas hospital/clinic setting with Brilacidin being administered with water in an enema. A foam formulation of Brilacidin for use in future studies is planned and would be expected to improve patient convenience and study results. The primary objective of Cellceutix’s Proof-of-Concept (PoC) trial is to assess the frequency of clinical remission (defined using Modified Mayo Disease Activity Index [MMDAI] scoring) with Brilacidin administered per rectum by enema in patients with active UP or UPS after 6 weeks of treatment. Additional objectives include: evaluation of safety and tolerability of Brilacidin when administered per rectum; assessment of systemic exposure and/or pharmacokinetics of Brilacidin when administered per rectum; assessment of the efficacy of Brilacidin by change in MMDAI at Day 42/Week 6 and Partial MMDAI during treatment and by biomarker evaluation (from serum, feces, and rectum/sigmoid biopsy samples); evaluation of change in patient-reported quality of life (by the Short Inflammatory Bowel Disease Questionnaire); and estimation of statistical power for subsequent trial(s) in UP and UPS. The PoC trial will include 18 patients divided evenly into three cohorts. Cohort A has received 50 milligrams (mg) of Brilacidin once daily administered per rectum as a retention enema for 42 days. Dosing increases to 100 mg and 200 mg 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, physical examination findings, vital signs, adverse events, use of concomitant medications, retention times) after 21 days of therapy for all six patients in each cohort before proceeding with initiating enrollment (dosing) into the subsequent cohort.