Cellceutix Requesting Meeting With FDA on Kevetrin for Pediatric Retinoblastoma

BEVERLY, MA--(Marketwired - August 24, 2015) - Cellceutix Corporation (OTC: CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, is requesting a meeting with the U.S. Food and Drug Administration (FDA) to discuss the advancement of the Company's anti-cancer drug candidate Kevetrin for the treatment of pediatric retinoblastoma.

Retinoblastoma is the most common eye cancer affecting children usually before age 3. It is sight threatening and potentially fatal if not caught early. Occurrence is 250-300 cases per year in the U.S. The tumors arise from the retina, the light sensitive nerve tissue which lines the back of the eye. If caught early and treated it may spare the child from having the eye removed (enucleated) which occurs in late stages to prevent metastasis.

The FDA recently released draft guidance on development of drugs intended to treat rare diseases (http://www.fdanews.com/ext/resources/files/08-15/08-17-15-rarediseases.pdf?1439565970). This guidance demonstrates the FDA's flexibility in drug discovery targeting rare disease and encourages sponsors to meet with the agency to design and implement clinical studies. The FDA also encourages development of drugs and biologics to prevent and treat rare pediatric diseases through its Pediatric Disease Priority Review Voucher (PPRV) incentive program. The program is set to expire in March 2016, but could be extended under a provision in the 21^stCentury Cures Act. Last week United Therapeutics Corporation agreed to sell its Priority Review Voucher to AbbVie for $350 Million. http://ir.unither.com/releasedetail.cfm?releaseid=928100

In 2013, Cellceutix conducted pre-clinical studies using human retinoblastoma cells (WERI-Rb-1) in nude mice that were implanted either subcutaneously or directly into the eye, intravitreally. Treatment with Kevetrin significantly reduced the tumor volume by more than half in the subcutaneous tumor model and showed a significant improvement in the clarity of the eye in mice treated with Kevetrin. Images from the research can be viewed at: http://cellceutix.com/kevetrin/#sthash.ODlFfr5M.HYqou6ox.dpuf.