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Jill Stone  |  by www.tradingmarkets.com. All rights reserved. 10.11 | 17:09

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(RTTNews) - Wednesday morning, Exelixis, Inc. ( | | | ), a development-stage biotechnology company dedicated to the discovery and development of novel small molecule therapeutics for the treatment of cancer and other serious diseases, released updated data from a Phase I trial of XL999, an investigational cancer therapy, administered weekly or every two weeks by intravenous or IV infusion. The company said that XL999 showed preliminary evidence of antitumor activity, consistent with the previous results of the study.

However, further enrollment for the Phase II trial has been suspended following reports of adverse cardiovascular events. Headquartered in South San Francisco, California, Exelixis stated that the Phase I trial had 45 patients and were evaluable for safety and tumor response assessments. Based on the three dosing regimens - weight based bi-weekly, weight based weekly, and fixed dose weekly dosing, the company grouped the 45 patients.

23 received weight-based dosing of XL999 administered every 2 weeks, 15 patients received weekly weight-based dosing of XL999 and seven patients received a weekly fixed dose of 200 mg XL999. Analyzing the outcome, the company observed that the weight-based and fixed dose dosing safety characteristics of XL999 have been similar in nature but less severe at lower doses than previously reported for the bi-weekly dosing regimen. The reported dose-limiting toxicity at 6.

4 mg/kg for the bi-weekly dosing regimen was fatal cardiac failure and elevated transaminases. At weekly 200 mg fixed dosing, serious adverse events considered included grade 3 hypotension, grade 3 ECG changes, and grade 3 increased troponin. All cardiac events occurred with the first dose of XL999.

The Phase II program for XL999 initiated in December 2005 is underway but the enrollment for the phase II has been suspended pending further review of data relating to cardiovascular adverse events. Gisela M. Schwab, M.

D., senior vice president and chief medical officer of Exelixis commented "We continue to believe in the potential of XL999 as a novel cancer therapy. We are placing patients' safety first and are diligently analyzing the clinical data available for XL999 to determine the appropriate next steps in the development of this novel cancer therapy.

" EXEL is currently trading at $8.93, down $0.21 or 2.

30%, on a volume of 473,238 shares.

Read more on by www.tradingmarkets.com. All rights reserved.
Keywords: Phase Ii, Phase i
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