SOURCE: Cellceutix

Cellceutix

June 15, 2016 11:45 ET

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

BEVERLY, MA--(Marketwired - June 15, 2016) - Cellceutix Corporation (OTC: 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.

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About Cellceutix:
Headquartered in Beverly, Massachusetts, Cellceutix is a publicly traded company under the symbol "CTIX". Cellceutix is a clinical stage biopharmaceutical company developing innovative therapies in multiple diseases. Cellceutix believes it has a world-class portfolio of compounds and is now engaged in advancing its compounds and seeking strategic partnerships. Cellceutix's anti-cancer drug Kevetrin concluded a Phase 1 clinical trial at Harvard Cancer Centers' Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center, and Cellceutix is now preparing its FDA application for a Phase 2 ovarian cancer study. In the laboratory, Kevetrin has shown to induce activation of p53, often referred to as the "Guardian Angel Gene" due to its crucial role in controlling cell mutations. Cellceutix is in a Phase 2 clinical trial with its novel compound Brilacidin-OM for the prevention of Oral Mucositis in patients with head and neck cancer. Brilacidin-OM, a defensin mimetic compound, has shown in an animal model to reduce the occurrence of severe ulcerative oral mucositis by more than 94% compared to placebo. Cellceutix's anti-psoriasis drug Prurisol completed a Phase 2 trial. Prurisol is a small molecule that acts through immune modulation and PRINS reduction. Cellceutix's lead antibiotic, Brilacidin, has completed a Phase 2b trial for Acute Bacterial Skin and Skin Structure Infections, or ABSSSI. Top-line data have shown a single dose of Brilacidin to deliver comparable clinical outcomes to the FDA-approved seven-day dosing regimen of daptomycin. Brilacidin has the potential to be a single-dose therapy for certain multi-drug resistant bacteria (Superbugs). Brilacidin is also being evaluated in a Phase 2 Proof-of-Concept trial as a novel treatment for Ulcerative Proctitis. Cellceutix has formed research collaborations with world-renowned research institutions in the United States and Europe, including MD Anderson Cancer Center, Beth Israel Deaconess Medical Center, and the University of Bologna. More information is available on the Cellceutix web site at www.cellceutix.com.

Forward-Looking Statements
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 that involve risks, uncertainties and assumptions that could cause Cellceutix's actual results and experience to differ materially from anticipated results and expectations expressed in these forward looking statements. Cellceutix has in some cases identified forward-looking statements by using words such as "anticipates," "believes," "hopes," "estimates," "looks," "expects," "plans," "intends," "goal," "potential," "may," "suggest," and similar expressions. Such forward- looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are Cellceutix's need for, and the availability of, substantial capital in the future to fund its operations and research and development; including the amount and timing of the sale of shares of common stock to Aspire Capital; the fact that Cellceutix's compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in Cellceutix's filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. Cellceutix undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.

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