Cellceutix
January 23, 2017
Cellceutix’s Brilacidin Demonstrates Promise in Treating Ulcerative Colitis Supported by Endoscopic Assessment, Patient-Reported Outcomes
Brilacidin
BEVERLY, MA – January 23, 2017 (GLOBE NEWSWIRE) Cellceutix Corporation, (OTCQB: CTIX) (“the Company”), a clinical stage biopharmaceutical company developing innovative therapies with dermatology, oncology, anti-inflammatory, and antibiotic applications, is pleased to update shareholders following its recent monthly conference call with the three clinical sites conducting Brilacidin’s Phase 2 Proof-of-Concept (PoC) study as a new treatment for ulcerative proctitis/ulcerative proctosigmoiditis (UP/UPS), limited forms of ulcerative colitis (UC).
Site investigators report enthusiastic feedback from patients currently receiving treatment in the second cohort with Brilacidin at 100 mg daily (by retention enema) for six weeks —comments included how the treatment already has greatly improved or eliminated their symptomatic complaints, daily functioning and overall quality of life. There is significant interest by new patients wishing to participate in the third (final) cohort once enrollment opens.
All six patients in the completed first cohort were treated with 50 mg of Brilacidin, once daily for six consecutive weeks (42 days), as a retention enema. The initial data showed Brilacidin to be well-tolerated with no severe adverse events reported and no detection of measurable systemic absorption. Preliminary review of endoscopic images and video from Screening and Day 42 in patients in the first cohort showed meaningful improvements for 5 of the 6 patients, including noticeable reductions in ulceration and bleeding. Such endoscopic data reflect the ability of Brilacidin to help clear Gastrointestinal (GI) tract mucosa in patients suffering from UC. The Food and Drug Administration (FDA), in 2016 draft guidance for UC, has conveyed the “ideal primary efficacy assessment tool” would include an “endoscopic and histological assessment scale,” in addition to a “patient-reported outcome instrument.” This guidance reinforces the importance of endoscopic remission as a critical efficacy measure toward gaining drug approval.
Endoscopic assessments, pharmacokinetic profiles, as well as patient/physician-reported outcomes, collectively, suggest that, even at the lowest dosing level (50 mg), Brilacidin offers potential to deliver a clinically meaningful, safe, and expedient therapeutic response among trial participants. These are the positive signals one looks for in a Proof-of-Concept study, to attract partnering companies. Registration trials for filing a New Drug Application (NDA) will require a final formulation and statistically powered studies with a control arm, which are not part of this PoC trial. The Company believes that while additional clinical data are needed to further corroborate findings, should future data remain consistent across the entire trial, Brilacidin could potentially emerge as a treatment for a wide range of Inflammatory Bowel Disease (IBD) indications. Moreover, as costly biologic therapies account for approximately 10 percent of overall pharmacy spending in the U.S., the need for less expensive treatments—an attribute Brilacidin can potentially offer the marketplace due to its lower cost of production—is becoming a real economic imperative.
Leo Ehrlich, Chief Executive Officer at Cellceutix, commented, “We unequivocally believe that Brilacidin can emerge as a novel drug in treating Ulcerative Colitis and other debilitating IBD conditions, which affect millions of people worldwide. Endoscopic assessments from the first cohort are particularly telling. We excitedly anticipate finishing the next two cohorts and sharing complete trial findings in the first half of 2017. Simply put, I believe that Brilacidin shows the potential to become one of the most sought after IBD drugs.”
Cellceutix looks forward to continuing to share data from the ongoing Proof-of-Concept trial and plans to present complete findings at a future Scientific Conference.
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Cellceutix is a publicly traded biopharmaceutical company dedicated to discovering and advancing innovative medical therapies with dermatology, oncology, anti-inflammatory and antibiotic applications.
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