Cellceutix secures preliminary approval for 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."