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State College company receives FDA approval for cancer therapy trials

A State College company has taken another step in the fight against cancer.

Biopharmaceutical outfit Keystone Nano is testing a way to deliver a cancer-killing lipid, the company announced Wednesday, and received U.S. Food and Drug Administration approval to start investigating the therapy in humans at three universities.

The trials will occur at the University of Maryland, the University of Virginia and the Medical University of South Carolina.

The company’s product, called the Ceramide NanoLiposome, is a tiny assassin. At about 80 nanometers — one nanometer is one billionth of a meter — the liposomes infiltrate tumor cells and unleash their payloads, an anti-cancer brew that has shown some effectiveness in reducing liver tumors in mice besides fighting pancreatic and lung cancer.

“This approval represents the conclusion of one phase of developing Ceramide, a truly novel anti-cancer agent, and the beginning of the very important human testing phase,” Keystone Nano CEO Jeff Davidson said in a release. “We are excited by the efficacy and lack of toxicity Ceramide NanoLiposome has shown in preclinical testing, and we look forward to continuing to evaluate Ceramide NanoLiposome for human use. This is a significant step forward in the development of Ceramide NanoLiposome for the treatment of cancer.”

The key factor, the company says, is that the liposome kills cancer cells, while leaving normal cells unharmed. Mylisa Parette, Keystone Nano’s vice president of research, said an effective delivery method for ceramide previously hasn’t existed.

“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,” she said in a statement.

The trials will be completed in phases. Phase one will recruit patients. Phase two will target liver cancer. According to the CDC, liver cancer kills about 24,000 in the United States each year.

No effective treatments currently exist.

Keystone Nano received a $2 million Small Business Investigational Research Grant from the National Cancer Institute in October 2015, which is being used to fund part of the trial.

Roger Van Scyoc: 814-231-4698, @rogervanscy

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