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

osphorylation of MET following administration of XL880. These decreases resulted in predicted downstream effects, including reduction of phosphorylated AKT levels and markedly increased tumor cell death. These effects were not observed in control samples of normal tissue obtained from the same patients. Pharmacokinetic analyses showed that peak and average concentrations over 28 days were higher with intermittent compared with daily dosing of XL880, reflecting the higher dose administered with the intermittent schedule, and the compound's long half life.

The data indicate that XL880 was generally well tolerated, and that the reported side effects were treatable and reversible. Dose limiting toxicities included hypertension, dehydration, hand-foot syndrome, tumor hemorrhage, and elevation of liver enzymes and lipase. Most of the common reported side effects are consistent with previously identified effects associated with inhibition of VEGF signaling, such as hypertension and proteinuria. Elevations in liver function tests also were observed and considered possibly related to XL880.

"We believe these results clearly demonstrate that XL880 simultaneously inhibits both MET and VEGFR2 in this clinical setting," said Michael M. Morrissey, Ph.D., president of research and development at Exelixis. "Inhibition of both MET and VEGFR2 abrogates two major mechanisms tumors use to survive in hypoxic conditions. The clinical data with XL880 suggest that dual MET/VEGFR2 inhibition has the potential to translate into meaningful anti-tumor activity in patients with advanced cancer."

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About XL880

XL880 has attractive pharmaceutical properties, with high solubility and oral bioavailability. In preclinical studies, XL880 inhibited its targets with nanomolar potency, and retained potent activity against mutationally activated forms of MET found in hereditary papillary renal cell carcinomas. The compound also demonstrated dose-dependent tu
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