GenVec‘s experimental drug to treat pancreatic cancer has been granted orphan drug status by the U.S. Food and Drug Administration (FDA). The drug candidate TNFerade stimulates the production of an immune system protein known for having anti-cancer effects. Shares in GenVec rose 25 percent following the announcement.
Last summer, Gaithersburg, Maryland-based GenVec announced positive data from a Phase II/III clinical trial of TNFerade. The drug provided a 42.5% reduction in the risk of death when combined with standard treatment, when compared to standard treatment alone. TNFerade is also being explored as a candidate to treat esophageal cancer, rectal cancer, and head and neck cancer.
More good news for GenVec: The company has signed a $22 million development deal with Science Applications International to develop HIV and flu vaccines. GenVec will receive approximately $2.6 million over the next year.
The FDA grants orphan drug designation to drugs that may be significantly more effective than currently existing treatments, and target conditions that affect less than 200,000 U.S. patients per year. Upon approval, drugs granted orphan status enjoy seven years of marketing exclusivity in the United States. The National Cancer Institute estimates that over 42,000 U.S. patients will be diagnosed with pancreatic cancer in 2009. There are no early symptoms of pancreatic cancer, so it is particularly challenging to diagnose in its beginning stages. The disease is difficult to control once it has spread. Pancreatic cancer is typically treated with surgery, chemotherapy, or radiation therapy, sometimes in combination.
Some other companies developing treatments for pancreatic cancer are Nanobiotix, Inovio Biomedical Corporation, AmpliMed Corporation, Celldex Therapeutics, and Ganymed Pharmaceuticals.