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Exelixis Initiates Phase 1/2 Trial of XL184 in Patients With Non-Small Cell Lung Cancer
Date:1/7/2008

ore than six months.

To date, five dose-limiting toxicities (DLTs) have been reported, including Grade 3 palmar/plantar erythema (hand-foot syndrome), Grade 3 AST elevation, Grade 3 ALT elevation, and Grade 3 lipase elevation in patients dosed at 11.52 mg/kg (intermittent dosing schedule), as well as a DLT of Grade 2 mucositis in a patient dosed at 265 mg (daily dosing schedule). Serious adverse events (AEs) considered possibly or probably related to XL184 include one report each of Grade 3 fatigue and Grade 3 pulmonary embolism. Dose escalation continues in order to determine a maximum tolerated dose (MTD).

About XL184

XL184 is a novel, orally administered, small molecule anticancer compound that in preclinical models has demonstrated potent inhibition of both MET and VEGFR2. XL184 has also exhibited potent inhibition of other important receptor tyrosine kinases (RTKs) that have been implicated in various forms of cancer including RET, KIT, FLT3, and TIE2. In preclinical efficacy studies, XL184 has inhibited tumor growth and induced the regression of large tumors in a broad range of human tumor xenograft models including breast cancer, lung cancer and glioma. In laboratory studies, XL184 has demonstrated good oral bioavailability and pharmacokinetic properties.

About Exelixis

Exelixis, Inc. is a development-stage biotechnology company dedicated to the discovery and development of novel small molecule therapeutics for the treatment of cancer and other serious diseases. The company is leveraging its fully integrated drug discovery platform to fuel the growth of its development pipeline, which is primarily focused on cancer. Currently, Exelixis' broad product pipeline includes investigational compounds in phase 2 and phase 1 clinical development for cancer and renal disease. Exelixis has established strategic corporate alliances with major pharmaceutical and biotechnology companies, including GlaxoSmithKline, Bristol-Myers Squibb Com
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SOURCE Exelixis, Inc.
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