- Accelerating Phase 2 trial for the Prevention of Severe Oral Mucositis (SOM)
- Annual Global Market for SOM may be in the hundreds of millions of dollars
BEVERLY, MA – April 10, 2017 (GLOBE NEWSWIRE) Cellceutix Corporation (OTCQB: CTIX), a clinical stage biopharmaceutical company developing innovative therapies with dermatology, oncology, anti-inflammatory and antibiotic applications, is pleased to provide shareholders information on the development plan for Brilacidin. Brilacidin is the Company’s flagship defensin-mimetic compound that has successfully completed a Phase 2b trial for Acute Bacterial Skin and Skin Structure Infections (ABSSSI) and is currently in two separate Phase 2 trials, for Oral Mucositis (OM) and Inflammatory Bowel Disease (IBD) [Ulcerative Proctitis-Ulcerative Proctosigmoiditis (UP/UPS)].
Cellceutix has in recent weeks provided interim results from both studies showing safety and preliminary indications of clinical benefits that have exceeded the Company’s expectations. Interested parties are encouraged to read the news on the data on OM at http://bit.ly/2n4X4GO and UP/UPS at http://bit.ly/2oupABw.
Upon acquiring Brilacidin in 2014, Cellceutix followed the same course as the prior owners of the compound by focusing development on its antibiotic properties, ultimately successfully completing a Phase 2b study demonstrating similar efficacy and safety of Brilacidin (0.6mg/kg IV; single dose) to the blockbuster antibiotic daptomycin in treating ABSSSI. Lab research concurrent to antibiotic trials provided equally impressive data on the anti-inflammatory and immunomodulatory properties of Brilacidin. These data underscored broadening the scope of research to build the franchise, developing formulations and initiating mid-stage trials aimed at the indications of preventing radiation-induced OM in Head and Neck cancer patients and inducing remission in UP/UPS.
Cellceutix is encouraged by the interim data from the OM trial (a double blind, placebo controlled study), given the fact that there are no FDA-approved drugs for the prevention of OM in the study population. According to the preliminary interim results from the trial, only 2 of 9 patients (22.2%) on Brilacidin-OM therapy developed severe OM, defined as Grade 3 or Grade 4 on the World Health Organization (WHO) OM Grading Scale. Patients in the placebo-treated control arm developed severe OM at a much higher rate, with 7 of 10 patients (70%) progressing to that condition. There are now an additional 11 patients active in the trial and more are added weekly.
In recent months, the number of study sites in the OM trial has been increased and enrollment is accelerating. Cellceutix has moved through this trial methodically, waiting to increase trial sites to conserve capital until research provided additional support to the potential of the anti-inflammatory and immunomodulatory properties of the drug candidate. As we saw signs of patient benefits in our open label UP/UPS trial, we started increasing the number of sites in the OM trial to hasten progression. Now that supportive data have been collected, efforts to expedite enrollment even faster are being implemented. In 2015, Cellceutix’s Brilacidin was granted FDA Fast-Track designation for the OM indication. Should the study conclude with similar results to those of the preliminary interim, we intend to seek FDA Breakthrough Therapy designation. Cellceutix expects the OM trial to be completed in 2017.
The Phase 2 UP/UPS (Proof-of-Concept, open label) trial continues to progress quickly and produce outstanding data. The results of the first two cohorts showed the majority of patients treated with Brilacidin at the end of six weeks had notable improvement based on the Modified Mayo Disease Activity Index (MMDAI) scoring and that half of patients met criteria for clinical remission. The third and final cohort of patients is currently in progress with expectations of presenting topline data in July at the 2017 Drug Discovery and Therapy World Congress in Boston. The presentation at this scientific conference will provide the wider scientific community with a portrait of Brilacidin’s potential for treating IBD as well as OM. Cellceutix believes there is a great need for an alternative medicine to existing treatments to achieve remission of distal ulcerative colitis via enema. We are guided by FDA registration trials for UCERIS® which showed 2mg rectal foam (foam enema) achieved modest remission rates of distal ulcerative colitis at six weeks (42 days).
“Looking back, when we ran across the opportunity to acquire Brilacidin and learned about the diverse potential of the compound, we considered it a once in a lifetime opportunity,” commented Leo Ehrlich Chief Executive Officer at Cellceutix. “We’re working on accomplishing something in OM that has never been accomplished before and tapping into the massive broad anti-inflammatory market opportunity at the same time. We believe with Brilacidin-OM that there is the potential to a quick path to market because of the lack of effective options for people suffering from Head and Neck cancer that must undergo chemoradiation and face the very real risk of severe OM. The condition is well documented to cause a spike in medical care costs, patient suffering, and contributes to a higher morbidity rate, so we strongly believe Brilacidin-OM treatment can gain support from FDA for rapid development and full support from insurance companies, hospitals, and doctors should the treatment eventually be commercialized. Reports are the annual global market for preventing severe OM may be in the hundreds of millions of dollars.”
Cellceutix will be hosting a shareholder conference call next week to further discuss accomplishments to date and pipeline development going forward. More details will follow early next week.
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