BOULDER, Colo., April 22 Clovis Oncology, Inc. and Ventana Medical Systems, Inc. announced today 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 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.
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 U.S., E.U., 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.
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. Published research has also suggested that hENT1 levels predict outcome in lung cancer patients treated with gemcitabine-containing chemotherapy. 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.
CO-101 Clinical Trial
CO-101 will shortly be directly compared to gemcitabine in an international, randomized, controlled trial in patients newly diagnosed with metastatic pancreatic cancer. The study will enroll approximately 250 patients, randomized between gemcitabine and CO-101, and measures overall survival (OS) in prospectively-defined hENT1-low patients as the primary endpoint. Expression of hENT1 in tumor tissue will be measured during the trial and patients categorized into hENT1-high or hENT1-low groups prior to final analysis. This study is a prospective test of two hypotheses: (1) that low pancreatic tumor hENT1 expression is associated with poor outcome after gemcitabine therapy, and (2) that CO-101 has superior efficacy (measured by OS) in hENT1-low patients compared with gemcitabine. This trial will commence enrollment in the second quarter of 2010, and data from this trial are expected in the first half of 2012.
About Clovis Oncology, Inc.
Clovis Oncology, Inc. is a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-cancer agents in the U.S., Europe and additional international markets. Clovis intends to target development programs at specific subsets of cancer populations, and will simultaneously develop diagnostic tools that direct a compound in development to the population that is most likely to benefit from its use. The Company is headquartered in Boulder, Colorado, and has additional offices in San Francisco and London.
About Ventana Medical Systems, Inc.
Ventana develops, manufactures, and markets instrument/reagent systems that automate tissue preparation and slide staining in clinical histology and drug discovery laboratories worldwide. The Company's clinical systems are important tools used in the diagnosis and treatment of cancer and infectious diseases. Ventana's drug discovery systems are used to accelerate the discovery of new drug targets and evaluate the safety of new drug compounds. In addition, the Company offers premier workflow solutions designed to improve laboratory efficiency, providing safeguards to enhance the quality of healthcare. Ventana is a wholly owned member of the Roche Group. For more information on Ventana Medical Systems, Inc. visit www.ventanamed.com.
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