Cellceutix Receives Preliminary Approval for Clinical Trial of Brilacidin for Ulcerative Proctitis

BEVERLY, MA–(Marketwired – March 30, 2016) – Cellceutix Corporation (OTC: CTIX) (the “Company”), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, is pleased to announce that the Company has received initial approval for the planned Proof of Concept, Phase 2, clinical trial of Brilacidin for ulcerative proctitis.
The local ethics committee, responsible for oversight and allowance of the trial, granted this approval, so the trial can now move forward. Cellceutix is now awaiting the country’s Ministry of Health permission so it may begin exporting Brilacidin into the country and directly to the clinical sites. The location of the trial isn’t currently being disclosed for competitive reasons.
“The ethics committee approval was the first key step in initiating the next developmental stage of Brilacidin, evaluating it in patients with ulcerative proctitis disease,” commented Leo Ehrlich, Chief Executive Officer at Cellceutix. “We are optimistic that the various properties of Brilacidin will help relieve patient pain and discomfort tied to inflammation and ulcerations — common symptoms that characterize ulcerative proctitis. This clinical trial is the third indication for Brilacidin and will provide us with valuable data as we continue to expand the list of possible uses for our potent compound.”
GlobalData, a research and consulting firm, estimated the global ulcerative colitis market, including products for ulcerative proctitis and ulcerative proctosigmoiditis, to increase at an annual rate of 4.7 percent, from $4.2 billion in 2012 to $6.6 billion by 2022.
“We strongly believe that Brilacidin can improve clinical outcomes of ulcerative proctitis patients as a non-corticosteroid treatment with anti-inflammatory benefits,” commented Dr. Kirshna Menon, Chief Scientific Officer. “Furthermore, ulcerative proctitis may prove to be a gateway indication for the larger ulcerative colitis markets — potentially demonstrating Brilacidin as a viable treatment for various gastrointestinal diseases, including Crohn’s disease.”
The Company will next update the public on this trial once patient enrollment begins at the trial site.
Separately, Cellceutix would like to inform shareholders that its Chief Medical Officer, Dr. Daniel Jorgensen, will be leaving Cellceutix, effective March 31, 2016, in order to pursue a unique opportunity in his specialized field at a privately held company. “I thank Dan for all his hard work and his accomplishments bringing our ABSSSI studies this far. He has worked diligently with our CRO (for the planned Phase 3 ABSSSI study). They already have selected the first sites for the study that can start once we get the final protocol approval from the FDA. I wish him and his family well in his new endeavor,” said Mr. Ehrlich. “Our previous Chief Operating Officer, Dr. James Alexander, who still actively consults for Cellceutix, will help us on clinical matters previously handled by Dr. Jorgensen. We believe Cellceutix is now becoming so much more than an oncology or antibiotic drug company. And we expect to be a big part of the solution in developing better drugs for gastro-intestinal diseases and dermatology as well. A lot of good things are happening. The future is bright.”
About Ulcerative Proctitis
Ulcerative proctitis, a mild form of ulcerative colitis, is a mucosal inflammatory disease of unknown cause. 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 to 50 percent of patients going on to develop ulcerative colitis. There currently is no cure.
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, 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 is in 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). 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
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