BEVERLY, MA–(Marketwired – July 15, 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 ovarian cancer.
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. Once approved, the product may qualify for seven years of marketing exclusivity in the United States.
“This is an important regulatory milestone for our novel compound Kevetrin,” commented Leo Ehrlich, Chief Executive Officer at Cellceutix. “This is in line with our strategy to initiate a Phase 2/3 trial of Kevetrin against ovarian cancers. We wanted to inform shareholders immediately of this important news and will be updating shareholders shortly on all clinical developments.”