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

y of XL999. Secondary objectives were to assess progression-free survival, duration of response, and overall survival with XL999. Patients in the studies received a once-weekly, 4-hour intravenous infusion of XL999 dosed at 2.4 mg/kg.

"We believe this integrated report provides a clear basis for the further development of XL999 with an appropriate risk-benefit profile," said Gisela M. Schwab, MD, senior vice president and chief medical officer at Exelixis. "On the basis of these data, further clinical evaluation of XL999 is planned in patients with stage IIIB-IV NSCLC in a Phase I dose-escalation study."

Integrated results from 79 patients who participated in the Phase II trials show preliminary evidence of XL999 activity in patients with NSCLC or AML. Of nine patients in the trial with NSCLC, two had partial responses (6 months and 11+ months), and three had stable disease for at least three months. Fourteen AML patients participated in the trial, of which ten had circulating myeloblasts. Eight of these ten patients experienced at least a 50% reduction in circulating myeloblasts following administration of XL999, one of whom achieved a partial response. Three of the 14 AML patients were found to have activating mutations in FLT3, including the patient who achieved a partial response. All three of these patients experienced a greater than 98% reduction in circulating myeloblasts.

With respect to the safety of XL999, serious cardiac adverse events occurred in 11 of the 79 patients (14%). These events were associated with the dose rate of XL999 and generally were associated with the first dose. Cardiac adverse events varied in severity, ranging from asymptomatic ECG changes to cardiopulmonary failure, and usually improved with discontinuation of XL999. Nine other non-cardiac serious adverse events associated with XL999 were reported: diarrhea (1), asthenia (1), pyrexia (2), hypersensitivity (2), vena cava thrombosis (1), dehydration (1), and pulmo
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