Cellceutix Receives FDA Orphan Drug Designation for Kevetrin for the Treatment of Retinoblastoma

Company’s Phase 2 Study of Plaque Psoriasis Completes Goal of Randomizing Subjects

BEVERLY, MA–(Marketwired – November 23, 2015) - 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 the U.S. Food and Drug Administration, or FDA, has granted Orphan Drug Designation to Kevetrin for the treatment of retinoblastoma, a rare form of eye cancer that begins in the retina, the light sensitive nerve tissue that lines the back of the eye. Retinoblastoma is most generally found in children, usually before the age of three, and rarely found in adults. It is sight threatening and potentially fatal if not diagnosed early.

The FDA’s Orphan Drug Designation program allows special incentives for sponsors planning to test a product for use in a rare disease or condition, defined as affecting fewer than 200,000 people in the United States. These incentives include federal grants, tax credits, and reduced filing fees during development or at the time of application for marketing approval. If approved for commercialization by the FDA, the product may qualify for seven years of marketing exclusivity in the United States.

Phase 2 trial of Prurisol – Plaque Psoriasis

In addition, Cellceutix is pleased to announce that we have completed our goal of randomizing 100 subjects into the study, one month ahead of projections. Prurisol is an orally administered small molecule for the treatment of plaque psoriasis. This is a double-blind, placebo controlled study using three different dosages of Prurisol. Patients are required to receive double-blind therapy for 12 weeks and then return to the clinic four weeks later for a total duration in the study of 16 weeks.