- 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
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. Alerts: Sign-up for Cellceutix email alerts is available at: www.cellceutix.com/email-alerts 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 first-in-class lead drug candidates and is now advancing them toward market approval, while actively seeking strategic partnerships. Cellceutix's psoriasis drug candidate Prurisol completed a Phase 2 trial and Cellceutix recently launched a Phase 2b study. Prurisol is a small molecule that acts through immune modulation and PRINS reduction. Cellceutix's anti-cancer drug Kevetrin successfully concluded a Phase 1 clinical trial at Harvard Cancer Centers' Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center, and Cellceutix has commenced a Phase 2 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 lead antibiotic, Brilacidin, has completed a Phase 2b trial for Acute Bacterial Skin and Skin Structure Infection, 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"). In an ongoing Phase 2 open label Proof-of-Concept trial, favorable interim results have been observed in the first two cohorts of patients treated with Brilacidin for Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS), two types of Inflammatory Bowel Disease (IBD). 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 including statements concerning projected timelines for the initiation and completion of clinical trials, our future drug development plans, other statements regarding future product developments, including with respect to specific indications, and any other statements which are other than statements of historical fact. These statements 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. 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. 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INVESTOR AND MEDIA CONTACTCellceutix CorporationLeo Ehrlichinfo@cellceutix.com