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Clovis Oncology Announces Enrollment Of First Patient In First Human Study Of Oral EGFR Mutant-Selective Inhibitor CO-1686

About CO-1686

CO-1686 is a targeted covalent (irreversible) inhibitor of EGFR mutations. CO-1686 was designed to selectively target both the initial activating EGFR mutations as well as the T790M resistance mutation, while sparing wild-type, or “normal” EGFR at anticipated therapeutic doses. CO-1686 is being clinically developed in patients with NSCLC associated with mutations in EGFR and has the potential to cause a lower incidence of skin rash and diarrhea, the primary toxicities associated with other EGFR inhibitors. Preclinical data presented in late 2011 demonstrated that CO-1686 causes tumor shrinkage in T790M-driven NSCLC xenograft models, and resulted in significant tumor growth inhibition at a variety of doses.

About EGFR and Lung Cancer

Lung cancer is the most common cancer worldwide with 1.35 million new cases annually, with NSCLC accounting for almost 85 percent of all lung cancers. NSCLC progresses rapidly with a five-year survival rate in advanced NSCLC patients of less than five percent. EGFR activating mutations occur in approximately 10 to 15 percent of NSCLC cases in Caucasian patients and approximately 30 to 35 percent in East Asian patients. These patients experience significant tumor response to Tarceva and Iressa, which are first-generation EGFR inhibitors. However, most patients ultimately progress on Tarceva and Iressa therapy, with approximately 50 percent of patients developing acquired resistance from a second, or “gatekeeper” mutation, T790M.

About Clovis Oncology

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 Oncology targets development programs at specific subsets of cancer populations, and simultaneously develops diagnostic tools that direct a compound in development to the population that is most likely to benefit from its use. Clovis Oncology is headquartered in Boulder, Colorado, and has additional offices in San Francisco, California and Cambridge, UK.

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