Cellceutix Corporation, a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, is pleased to announce that it received the letter from the U.S. Food and Drug Administration (FDA) granting Orphan Drug Designation to Kevetrin for the treatment of pancreatic cancer. The work underscoring the new designation was conducted by Cellceutix scientists in collaboration with pancreatic cancer specialists at a world renowned clinic headquartered in Rochester, Minnesota, in preparation for a recently filed grant application.
Last year, an estimated 48,960 adults (24,840 men and 24,120 women) in the United States were diagnosed with pancreatic cancer. It is estimated that 40,560 deaths (20,710 men and 19,850 women) from this disease occurred. Pancreatic cancer is the eighth most common cancer in women and the fourth leading cause of cancer death in men and women. A notoriously difficult disease to treat, pancreatic cancer has a five-year survival rate of only 7.2 percent.
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.
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