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Trial Underway Testing Pancreatic Cancer Immunotherapy

Listeria bacteria

Listeria bacteria (CDC.gov)

10 February 2014. Aduro BioTech Inc. in Berkeley, California started treating ist first patients in an intermediate-stage clinical trial of immunotherapies for pancreatic cancer. The trial is expected to enroll 240 patients at 20 sites in the U.S. and Canada, and is still recruiting participants.

Pancreatic cancer is often difficult to diagnose in its early stages, because of few unique symptoms associated with the disease, and because the pancreas is hidden among other organs in the body. As a result, it is often diagnosed in later, more advanced stages of the disease. According to National Cancer Institute, some 45,220 cases of pancreatic cancer were reported in the U.S. during 2013, with 38,460 deaths occurring from the disease.

The clinical trial is testing Aduro’s immunotherapy technology that creates a vaccine from an engineered form of listeria bacteria the company calls CRS-207, targeting specific tumor cells. Listeria, in its natural form, is a bacterium associated with food poisoning, but in the lab can be weakened and engineered to safely deliver antigens to stimulate an immune response. Aduro calls its cancer antigens GVAX, which in this case target tumors in the pancreas.

The trial is treating patients with metastatic (spreading) pancreatic cancer, randomly divided into three groups, each receiving for 16 weeks one of the following treatment regimens:

– A combination of CRS-207 and GVAX, with low doses of the immune-system suppressant cyclophosphamide
– CRS-207  alone
– Current state-of-care chemotherapies

The primary measure of effectiveness for the treatments is overall survival, with the patients followed over three years. The trial is also watching for adverse reactions to the treatments.

In January, researchers at Johns Hopkins University medical center reported findings from another intermediate-stage trial of CRS-207 and GVAX at a professional meeting on gastrointestinal cancers. The findings showed pancreatic cancer patients receiving the combination of CRS-207 and GVAX had a longer median overall survival time (6.1 months) compared to patients receiving only GVAX (3.9 months). The team was able to stop the trial earlier than anticipated because of the results.

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