Cellceutix Corporation (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.
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 oncology, dermatology and antimicrobial applications. Cellceutix believes it has a world-class portfolio of compounds and is now engaged in advancing its compounds and seeking strategic partnerships. Cellceutix's anti-cancer drug Kevetrin is currently in a Phase 1 clinical trial at Harvard Cancer Centers' Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center. 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 anti-psoriasis drug Prurisol is in a Phase 2 trial. Prurisol is a small molecule that acts through immune modulation and PRINS reduction. Cellceutix's lead antibiotic, Brilacidin, has completed a Phase 2b trial for Acute Bacterial Skin and Skin Structure Infections, 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). 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.
