Phase I Data for Exelixis' Kit Inhibitor XL820 Presented at EORTC
Wednesday November 8, 6:05 am ET
PRAGUE, Czech Republic, Nov. 8 /PRNewswire-FirstCall/ -- Exelixis, Inc. (Nasdaq: EXEL - News) announces that preliminary Phase I results were reported today from an ongoing trial of XL820, an oral small molecule compound which inhibits KIT, PDGF and VEGF and is designed to inhibit tumor growth and angiogenesis. Results show that dosing of XL820 for five consecutive days every two weeks was generally well tolerated, and a maximum tolerated dose (MTD) has not yet been identified. Dr. Alain Mita and Dr. Kyriakos P. Papadopolous of the Institute for Drug Development, Cancer Therapy and Research Center in San Antonio and an investigator on the study presented the data in a poster (Abstract #97) at the 18th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics, which is being held November 7-10 in Prague, Czech Republic.
As of September 22, 2006, 23 patients had been enrolled in the trial. Patients received XL820 orally on an intermittent schedule with 5 daily doses given every 2 weeks. Twenty-two were evaluable for safety assessments and 19 were evaluable for tumor response. As reported by the investigators, four patients have had stable disease for 3.5+ to 11+ months (one each with gastrointestinal stromal tumor [GIST], renal cell carcinoma, testicular cancer and thyroid cancer). One instance of dose-limiting toxicity has been reported (grade 3 elevation of aspartate aminotransferase); no grade 4 adverse events considered related to XL820 have been reported to date.
"We are encouraged by the favorable safety profile observed to date in this initial trial of XL820," said Gisela M. Schwab, M.D., senior vice president and chief medical officer of Exelixis. A daily dosing regimen of XL820 is currently under evaluation in a separate Phase I study." |
