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Clinical Trial to Study Potential Drug Treatment for Liver Cancer and Advanced Solid Tumors

USC Norris Comprehensive Cancer Center has embarked on a phase 1 clinical trial to evaluate a new kind of treatment for cancers of the liver and advanced solid tumors that have spread to the liver.

The trial, backed by the National Cancer Institute, will study a drug known as AU409, which has been shown in preclinical trials to interrupt the cancer cell’s machinery, preventing it from using DNA code to produce proteins that it needs to grow.

Liver cancer is estimated to be the third most common cause of cancer-related deaths worldwide, and hepatocellular carcinoma (HCC) accounts for about 80% of all liver cancers.

Despite major improvements in treatment, patients with advanced HCC continue to have limited median overall survival due to primary or secondary resistance to existing therapies.

While chronic hepatitis B and C infections continue to be important risk factors for liver cancer, the rising prevalence of obesity, non-alcoholic steatohepatitis (NASH) and alcohol consumption are becoming the dominant risk factors for liver cancer in the United States as well as the rest of the world.

The trial will involve USC Norris patients with advanced primary liver cancers or with advanced solid tumors with liver predominant metastatic disease. Its principal investigator is Anthony El-Khoueiry, MD, director of the phase I program and associate director for clinical research at USC Norris.

El-Khoueiry is a leading expert in early drug development for solid tumors, particularly gastrointestinal cancers.

“AU409 has a unique mechanism of action that impacts gene expression in the tumor and may represent a novel therapeutic approach for these tumors with high unmet need,” El-Khoueiry said.

The AU409 trial is part of a broader approach by USC Norris’ Rosalie and Harold Rae Brown Center for Cancer Drug Development to develop novel and much-needed therapies for cancer patients.

“The Brown Center for Cancer Drug Development takes an integrated, academic-industry approach to achieve our mission of accelerating promising oncology therapeutics into the clinic through collaborative drug development,” said Caryn Lerman, PhD, director of USC Norris.

On this trial, USC Norris is collaborating with Auransa Inc., a clinical stage drug development company focused on identifying novel drug candidates for cancer and other diseases.