Home > Press > Keystone Nano Announces The US FDA Has Awarded Orphan Drug Designation For Ceramides For The Treatment Of Liver Cancer
Abstract:
Keystone Nano is pleased to announce that that it has received orphan drug status for the use of Ceramide to treat Liver Cancer from the 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.
Keystone Nano Announces The US FDA Has Awarded Orphan Drug Designation For Ceramides For The Treatment Of Liver Cancer
State College, PA | Posted on November 8th, 2016Evidence 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.
Keystone has a 90 second animation that describes its technology at: https://www.youtube.com/watch?v=2rjcx4G0Vl0 . The animation highlights a few key aspects of the technology. More detail can be found at the web site, including links to many published papers describing the science conducted to date.
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About Keystone Nano
Based in State College, PA, Keystone Nano is working at the interface between nanotechnology and the life sciences. The company is commercializing Ceramide NanoLiposome and additional products using NanoJackets, calcium phosphate nanoparticles that may be targeted to specific cell types, for a variety of medical applications. The Company's product pipeline is protected by a patent portfolio comprised of 11 patent families that has resulted in 14 issued patents and 8 pending applications to date.
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