FDA Approves Investigational New Drug Application for Ceramide NanoLiposome

The FDA has approved the investigational new drug application from Keystone Nano for Ceramide NanoLiposome to assess the product as a form of treatment for solid tumors. It will be tested in a phase 1 trial at the University of Maryland, University of Virginia, and the Medical University of South Carolina.

Through testing, the goal is to determine a safe dose level, as well as the efficacy of the drug as a treatment for cancer. In the past, ceramide has shown efficacy when used for liver, pancreatic, and breast cancer, as well as leukemia. Research tests indicate that Ceramide NanoLiposome can kill cancer cells without negatively impacting normal cells.

"The anti-cancer activity of ceramide has long been known in the laboratory," Dr. Mylisa Parette, Keystone Nano's Vice President of Research, said in a press release. "The proprietary formulation we are evaluating uses ceramide integrated into the membrane of a nanoliposome to overcome these barriers and allow us to exploit the novel properties of ceramide as an anti-cancer therapy."

In the phase 1 portion of the upcoming trial, patients with solid tumors will be recruited to determine dosing and safety for Ceramide NanoLiposome. A phase 2 portion will focus on liver cancer.

"This approval represents the conclusion of 1 phase of developing Ceramide, a truly novel anti-cancer agent, and the beginning of the very important human testing phase," Jeff Davidson, Keystone Nano's CEO, said in a press release. "This is a significant step forward in the development of Ceramide NanoLiposome for the treatment of cancer."