Cellceutix Phase 2 Trial of New Oral Treatment for Psoriasis Nearing Completion

BEVERLY, MA–(Marketwired – January 25, 2016) Cellceutix Corporation (OTC: CTIX) (the “Company”), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, is pleased to announce that approximately 75 percent of the subjects enrolled in the Company’s Phase 2 clinical trial of Prurisol for the treatment of chronic plaque psoriasis have completed dosing, defined as 84 days of daily treatments of Prurisol or placebo.  The subjects will now be followed for an additional 4 weeks, without taking any further study medication.

The four-arm multi-center Phase 2 trial, three arms with different dosing regimens of Prurisol and one armplacebo, is designed to assess the efficacy and safety of Prurisol given orally compared to placebo in a randomized, double-blind setting in patients with mild to moderate chronic plaque psoriasis. The trial was expected to enroll 100 subjects and actually enrolled 115 subjects. The primary efficacy endpoint will be the percentage of subjects with greater than or equal to a 2-point improvement in Investigator’s Global Assessment (IGA) rating as defined by visual inspections of patient lesions. The final study visit for the last subject is expected early in April 2016, with top-line data anticipated approximately four weeks later.

“The completion of this study of Prurisol will mark another important milestone for Cellceutix.  I am very eager to see the unblinded data, as we structured this trial to give us a broad view of the activity of Prurisol in humans,” commented Edward Walters, Head of Clinical Operations at Cellceutix.  “The goal is to show the compound is safe and effective, while pointing us to an optimal dosing regimen for a late-stage trial.  For the good of the millions of people suffering from psoriasis, we hope that Prurisol can one day provide a much-needed option to often-used biologics that are known to have side effects and contraindications, while eventually losing effectiveness in many patients.”

More of the Phase 2 study of Prurisol can be found at: https://clinicaltrials.gov/ct2/show/NCT02494479?term=cellceutix&rank=2