Keystone Nano, a company is working at the interface between nanotechnology and the life sciences, has received orphan drug status for the use of Ceramide to treat liver cancer from the US FDA.
This very important designation provides key benefits to the company including a period of market exclusivity upon product approval. “We are pleased to be granted orphan drug status as this helps Keystone Nano accelerate the development of Ceramide NanoLiposome (KN-001) for the patients battling liver cancer”, remarked Jeff Davidson, Keystone’s chief executive officer.
Evidence collected in a very large number of carefully conducted research tests (in vitro and in vivo) demonstrate that Ceramides can kill cancer cells while leaving normal cells alone, providing treatment without undo toxicity. Ceramides have not been previously tested as cancer therapies, and Keystone Nano has developed a highly unique NanoLiposome designed to deliver Ceramide effectively to cancer cells. Keystone Nano has conducted a large number of preclinical tests on the Ceramide NanoLiposome exploring its safety and is planning clinical testing in the near future.
Liver Cancer currently kills approximately 25,000 people in the United States, and kills approximately 700,000 worldwide. There is not currently an effective therapy for this disease.
