Keystone Nano is pleased to announce that the National Cancer Institute (NCI) has awarded it a $2 million grant to support a Phase I clinical trial to determine the safety of Keystone’s Ceramide Nanoliposome (CNL) as a cancer therapy. The Small Business Investigational Research (SBIR) Grant is highly competitive and reflects a significant commitment from the NCI to support the development of this technology.
The grant supports a wide range of activities required to test the Ceramide Nanoliposome in humans at several leading cancer clinics. This first in human testing of the Company’s lead product will allow Keystone to learn more about the therapy’s effect in patients. The clinical trial is expected to begin in early 2016.
Dr. Mylisa Parette, Keystone Nano’s lead investigator on this project, remarked: “The CNL has a unique mechanism that selectively kills cancer cells while not affecting normal cells. It also delivers the drug in a NanoLiposome which provides further advantages. We are excited to take this next important step of determining the safety of this approach for cancer patients.”
Edward A. Sausville, M.D., Ph.D., co-investigator on this project as well as Deputy Director and Associate Director for Clinical Research at the University of Maryland Marlene and Stewart Greenebaum Cancer Center, noted: “CNL is a new strategy to deliver a drug ‘payload’ to cancer cells. It uses a “platform”—the Nanoliposome— to deliver Ceramide, a regulator of cancer cell behavior, to cause cancer cell death. What is exciting is that many other different types of payloads could possibly use the Nanoliposome platform.
CNL could pave the way for a new generation of drugs, each using the Nanoliposome platform to personalize a specific payload to a specific tumor type.” Mr. Jeff Davidson, Keystone Nano’s Chief Executive Officer, noted: “We are pleased to have NCI support to further develop and test this therapy. We look forward to determining if it can improve the treatments available for cancer patients.”
Testing is planned at three clinical centers: The University of Maryland Greenebaum Cancer Center, the University of Virginia and the Medical University of South Carolina. Ceramide Nanoliposomes have shown highly positive effects with no toxicity in multiple animal models of cancer including human liver cancer, breast cancer, melanoma, pancreatic cancer and leukemia.
Keystone Nano has been awarded several National Institute of Health (NIH) grants and a Pennsylvania Department of Health grant to develop nanoparticles for the treatment of cancer. Based in State College, PA, Keystone Nano is working at the interface between nanotechnology and the life sciences. Keystone Nano, which is building on technology licensed from Penn State University, is working to commercialize products for a variety of medical applications.
For more information about Keystone Nano, visit our website www.keystonenano.com, or contact Jeff Davidson.
For more information about the National Cancer Institute visit http://www.cancer.gov/about-nci.
For more information about the University of Maryland Greenebaum Cancer Center, visit www.umgcc.org .