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Clinical Data Reported on Vidaza in Hematologic Malignancies and,Advanced Solid Tumors

rstCall/ -- Exelixis, Inc. (Nasdaq: EXEL) reported data from the Phase I clinical trial program for XL880, a novel small molecule compound that simultaneously inhibits MET and VEGFR2, targets implicated in tumor growth, tumor cell migration, and angiogenesis. Patricia M. LoRusso, D.O., Director of the Phase I Clinical Trials Program at the Barbara Ann Karmanos Cancer Institute, Professor of Hematology and Oncology at Wayne State University, and a lead investigator in the trial, presented the data in the Developmental Therapeutics: Molecular Therapeutics oral abstract session (Abstract #3526) at the 43rd Annual Meeting of the American Society of Clinical Oncology (ASCO).

The data presented were taken from two Phase I studies of XL880 in patients with advanced solid tumors. One study evaluated an intermittent, weight-based dosing regimen and the other evaluated fixed daily dosing. Both studies included pharmacokinetic, pharmacodynamic, and tumor response analyses.

Five partial responses (>30% tumor regression by RECIST) were observed, including three in papillary renal cell cancer, one in medullary thyroid cancer, and one in hurthle cell thyroid cancer. Tumor shrinkage of less than 30% or prolonged stable disease of greater than 3 months was observed in an additional 20 patients. Additionally, in a best response evaluation as determined by RECIST criteria, investigators reported that 39 of 45 patients in the combined phase 1 studies had either tumor regression or stable disease.

"We consider the number of patients with responses or disease stabilization in these studies to be quite striking, particularly in light of these patients' advanced disease," said Dr. LoRusso. "We believe XL880 has significant potential as a novel cancer therapy, and the ongoing Phase II trials should provide important insight into the late stage development plans for the compound."

Histological analyses of tumor samples from four patients showed decreases in the ph
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