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Updated Phase 1 Data for Exelixis' XL184 Demonstrate Pharmacodynamic and Clinical Anti-Tumor Activity
Date:10/23/2007

atients received two cycles of XL184 administered as a daily oral dose for 5 consecutive days with a 9-day observation period (0.08-11.52 mg/kg), or dosed daily (175 and 265 mg). Patients may remain on study in the absence of unacceptable toxicity or progressive disease. Primary endpoints of the trial are to evaluate the safety and tolerability of XL184, determine the MTD of XL184, and to evaluate the plasma pharmacokinetics of XL184 administered orally to patients with advanced malignancies. Secondary endpoints are to assess the preliminary anti-tumor activity after repeat administration of XL184, and to assess the effects of XL184 on vascular permeability in patients enrolled at the MTD. An evaluation of the pharmacodynamic effects of XL184 is being conducted as an exploratory endpoint.

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 ren
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