Assay Identifies Patients with Low Tumor Expression of hENT1

A human equilibrative nucleoside transporter 1 (hENT1) immunohistochemistry (IHC) assay will be used in clinical trials of a new drug to identify pancreatic cancer patients with a low-level tumor expression of hENT1 protein.

The new drug, CO-101 is an investigational, lipid-conjugated derivative of gemcitabine, currently in clinical trials. It is designed to improve upon the efficacy of gemcitabine by enabling the drug to enter cancer cells without requiring membrane expression of transporter proteins.

As a hydrophilic molecule, the entry of gemcitabine into tumor cells is dependent upon the expression of specific membrane transporter proteins, particularly hENT1. Gemcitabine is the current standard treatment for advanced pancreatic cancer, and is also used in combination with other chemotherapy agents for the treatment of other cancers, including ovarian, non-small-cell lung cancer, and breast cancer.

Clovis Oncology, Inc. (Boulder, CO, USA) and Ventana Medical Systems, Inc (Tucson, AZ, USA), a fully owned member of the Roche Group, announced that they have entered into a collaboration agreement for the development of the hENT1 assay. If the CO-101 is successfully developed, Clovis Oncology will submit new drug applications in the U.S., E.U., and other international markets and Ventana Medical Systems will submit the hENT1 assay for premarket approval as a Class III device.

"The collaboration with Clovis Oncology further underscores our commitment to personalized healthcare. This partnership is a great example of how our combined expertise in diagnostics and pharmaceuticals enable us to innovate healthcare, by developing tests that ultimately deliver the right treatment to the right patient," says Hany Massarany, president of Ventana Medical Systems, Inc.

Approximately 50% of pancreatic cancer patients have been shown to have low tumor expression of hENT1. In a number of independent studies of patients with pancreatic cancer, low levels of tumor hENT1 expression have been shown to correlate with poor survival outcomes after gemcitabine therapy. These observations support the hypothesis that limited tumor uptake of gemcitabine in hENT1-low patients is responsible for a poor treatment effect in many patients. Since CO-101 has been shown to enter tumor cells in a transporter-independent manner, it may offer substantial therapeutic benefit to the large and potentially poorly served group of hENT1-low patients.

Clovis Oncology, Inc. is a biopharmaceutical company focused on acquiring, developing, and commercializing anticancer agents in the U.S., Europe, and additional international markets.

Ventana develops, manufactures, and markets instrument/reagent systems that automate tissue preparation and slide staining in clinical histology and drug discovery laboratories worldwide.

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Clovis Oncology, Inc.
Ventana Medical Systems, Inc