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

lasting from three months to up to 20 months, including nine patients with stable disease for more than six months.

Preliminary analyses of pharmacodynamic samples show changes in VEGF-A, sVEGFR2 and PIGF consistent with effects observed with other antiangiogenic agents. Preliminary pharmacokinetic analyses of nine dose levels (0.08-11.52 mg/kg) indicate a long half-life of XL184 of 59 to 136 hours.

"In this study of XL184, we observed partial responses in patients with medullary thyroid cancer and tumor shrinkage in a patient with papillary renal cell cancer, which frequently have mutational activation or overexpression of RET or MET, respectively," said George A. Scangos, Ph.D., president and chief executive officer of Exelixis. "We believe the data to date demonstrate the potential of simultaneous inhibition of MET, RET, and VEGFR, and validate our ability to discover and develop compounds that simultaneously inhibit critical pathways in cancer. We are excited about the potential of XL184 to provide effective therapy for patients with a variety of tumor types, and we intend to advance XL184 into a phase 2 program by the end of 2007."

To date, five dose-limiting toxicities (DLTs) have been reported, including Grade 3 palmar/plantar erythema, Grade 3 AST elevation, Grade 3 ALT elevation, and Grade 3 lipase elevation in patients dosed at 11.52 mg/kg, as well as a DLT of Grade 2 mucositis in a patient dosed at 265 mg. 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 the Trial

This phase 1, open-label, dose-finding trial is being conducted in patients aged 18 years or older with histologically confirmed advanced solid malignancy or lymphoma that is metastatic or unresectable and for which alternative therapies do not exist or are no longer effective. P
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SOURCE Exelixis, Inc.
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