Clovis Oncology Inc and Ventana Medical Systems Inc announced that they have entered into a collaboration agreement for the development of a human equilibrative nucleoside transporter 1 (hENT1) immunohistochemistry (IHC) assay, which will be used in Clovis’ CO-101 clinical trials to identify patients with low level tumor expression of hENT1 protein.
If CO-101 is successfully developed, Clovis Oncology will submit new drug applications in the US, EU, and other international markets and Ventana Medical Systems will submit the hENT1 assay for Premarket Approval as a Class III device.
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, and breast cancer. CO-101 has been granted orphan drug status for the treatment of pancreatic cancer in the U.S. and E.U. Clovis licensed rights from Clavis Pharma for CO-101 in the US, EU, and select other countries in November 2009.
Patrick Mahaffy, Chief Executive Officer and President of Clovis Oncology, said, "Given Ventana’s proven record as a market leader in the development of companion diagnostics, we are very pleased to partner with them to substantiate and develop hENT1 protein expression as a companion diagnostic for CO-101. We are fully committed to the use of companion diagnostics to identify patients who may show superior benefit from our products, and believe this partnership is an important step in the focused development of CO-101."
"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.
Source: Clovis Oncology
