Cellceutix Starts Phase 2 Trial of Brilacidin as a Novel Therapy for Ulcerative Proctitis

BEVERLY, MA--(Marketwired - June 15, 2016) - Cellceutix Corporation (CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, antibiotic, and anti-inflammatory applications, today announces that patients have been screened and the administration of Brilacidin to patients is expected to begin this week in the Phase 2 Proof of Concept trial of Brilacidin for the treatment of ulcerative proctitis.

Given its robust anti-inflammatory properties, Brilacidin offers patients a promising non-corticosteroid alternative to current clinical treatments. Long-term use of rectal corticosteroids should be avoided, as it can produce potentially serious side effects.

The ulcerative proctitis trial is planned to enroll 18 adult patients with Brilacidin administration through retention enema at three different concentrations once daily at bedtime for a 6-week (42-day) period. 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). All endoscopic evaluations (screening and Day 42) will be photographed and videotaped for eventual adjudication by an independent observer (a gastroenterologist) who is blinded to the day of on-treatment endoscopy and the dosage of Brilacidin used. This process of blinded adjudication (assessing overall results) will be performed after the study's completion and will not delay patient enrollment.

Designed as a Proof of Concept trial based on considerable pre-clinical work, the study's primary goal is the remission of the condition. A successful Proof of Concept ulcerative proctitis trial would be a key step in advancing the Brilacidin franchise into other inflammatory bowel diseases. The 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 further studies is in development.

The Company is excited to see this important study commence. We are hopeful that Brilacidin can prove itself to be a new treatment for patients with ulcerative proctitis and look forward to Brilacidin possibly emerging as a novel therapy for the millions of patients suffering from this and other difficult-to-treat inflammation-based gastrointestinal conditions. Should this trial deliver encouraging results, Brilacidin's treatment of ulcerative colitis and Crohn's disease likely would be warranted.

About Ulcerative Proctitis 

Ulcerative proctitis, a mild form of ulcerative colitis, is a mucosal inflammatory disease of unknown cause involving only the rectum or the distal colon and the rectum (proctosigmoiditis). It is characterized by rectum inflammation, redness, and ulcerations of the lining of the rectum. 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 ulcerative colitis. There is currently no cure. According to estimates provided by GlobalData, the worldwide ulcerative colitis market, which includes products for ulcerative proctitis and ulcerative proctosigmoiditis, 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 Brilacidin

Brilacidin is the first of a completely new class of antibiotics called defensin-mimetics. Modeled after the body's innate host-defense response, Brilacidin kills bacteria quickly and efficiently, penetrating bacterial cell wall membranes. Given this mechanism-of-action, resistance is much less likely to develop. Beyond its robust antimicrobial properties, Brilacidin also functions in an immunomodulatory capacity, lessening inflammation and promoting healing.