Exelixis begins phase 2 trials for cancer drug XL999

By Angela McDaniels

Seattle, Dec. 20 - Exelixis Inc. said it has begun a six-trial, phase 2 clinical development program for its XL999 compound in several cancer indications.

Four solid-tumor clinical trials (renal cell carcinoma, colon, ovarian and non-small cell lung cancer) are open for patient enrollment at several centers in the United States. Two additional trials, in acute myelogenous leukemia and multiple myeloma, are expected to begin soon.

"We are very pleased to initiate the first phase 2 clinical trial for an internally discovered compound, and we are on track to have two additional internally generated compounds in phase 2 trials in the first quarter of 2006," president and chief executive officer George A. Scangos said in a company news release.

"We believe the initiation of these trials reinforces our position as a product development company, and we are confident that we are pursuing the most effective development strategy to support successful later-stage clinical development efforts."

The phase 2 trials of XL999 will evaluate the compound as a single agent, looking for responses in patients who have failed prior therapies. Some of the studies are also designed to evaluate single-agent activity of XL999 in previously untreated patients for whom conventional therapy is not appropriate, the company said.

Additionally, Exelixis said it is considering trials of XL999 either in combination with other anti-angiogenic compounds or with cytotoxic chemotherapy.

XL999, a spectrum selective kinase inhibitor, is a potent small molecule inhibitor of key receptor tyrosine kinases implicated in the development and maintenance of tumor vasculature and in the proliferation of some tumor cells, the company said.

Data from the phase 1 trial of XL999 in patients with advanced solid showed that of 22 patients who had been followed for eight weeks or more, two had partial responses, one had a minor response and four patients experienced stable disease for three to seven months.

Exelixis is a biotechnology company based in South San Francisco that develops therapeutics for cancer and other serious diseases.

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