BEVERLY, Mass., Oct. 26, 2016 (GLOBE NEWSWIRE) -- Cellceutix Corporation, (CTIX) (“the Company”), a clinical stage biopharmaceutical company developing innovative therapies with dermatology, oncology, anti-inflammatory, and antibiotic applications, is pleased to announce today that the favorable pharmacokinetic profile of Brilacidin in Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS) supports Brilacidin’s potential in treating patients in our ongoing, FDA Fast Track-designated, Phase 2 study of Brilacidin-OM as an oral rinse to attenuate Oral Mucositis in patients with Head and Neck Cancer receiving chemoradiation.
As previously reported, initial interim results in UP/UPS, a type of Inflammatory Bowel Disease (IBD), revealed clinically meaningful improvements in the first cohort of four patients treated with Brilacidin at the lowest dose (50mg). Localized treatment with Brilacidin at 50mg by daily enema administration for 42 days produced clinical benefit without measurable plasma drug levels. More specifically, measurements of concentrations of Brilacidin in plasma showed all levels, across all time points, to be below the lower limit of quantification (i.e., <100 ng/mL), which is consistent with limited systemic exposure from administration per rectum by enema.
These data suggest that other inflammatory conditions may, likewise, be treated locally and efficaciously with Brilacidin without significant systemic absorption, better ensuring a safe and well-tolerated therapeutic profile. Given Brilacidin’s low level of systemic exposure, moderate-to-high dosing of the drug by topical application to the skin might also be supported in treating various dermatology disorders and conditions.
Additional reporting of results from the Phase 2 Proof-of-Concept (PoC) clinical trial of Brilacidin-UP/UPS is anticipated over the coming months, as is an interim analysis in the first half of 2017 of the Phase 2 clinical trial of Brilacidin-Oral Mucositis.
“Cellceutix is on the cusp of proving our drug candidates to be truly transformative medicines,” said Jane Harness, Cellceutix VP, Clinical Sciences and Portfolio Management. “The results that we’re already seeing in Inflammatory Bowel Disease are incredibly encouraging, leading us to believe that there is a solid clinical basis to extend Brilacidin into treating multiple indications.”
Other corporate news: The Company will soon be updating clinicaltrials.gov to reflect the planned start of its Phase 2b study of Prurisol, an oral compound for treating moderate-to-severe chronic plaque psoriasis. Prurisol will be tested at higher doses and evaluated using the Psoriasis Area and Severity Index (PASI) scoring method, enabling a direct comparison to approved psoriasis drugs. Regarding the planned Phase 2a study of Kevetrin, a p53-activating anti-cancer agent, in late-stage ovarian cancer, the protocol is undergoing a final internal review before submission to the FDA, a process expected to be completed next month. Communications also continue with the FDA on the Company’s Special Protocol Assessment (SPA) request for its planned Phase 3 clinical trial of single-dose Brilacidin in the treatment of Acute Bacterial Skin and Skin Structure Infection (ABSSSI) caused by Gram-positive bacteria.