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Exelixis Reports Positive Clinical Pharmacodynamics Data for PI3K/mTOR Inhibitor XL765 at ASCO
Date:5/31/2008

from preclinical studies, and suggests that XL765 inhibits PI3K and both mTOR/raptor and mTOR/rictor in patients.

XL765 administration also resulted in the augmentation of food-induced changes in plasma insulin in an exposure-dependent fashion, but generally had no effect on plasma glucose levels. PI3K is known to play a key role in insulin signaling, and PI3K inhibition has been shown to increase insulin levels in preclinical models.

Five patients with various cancers have experienced stable disease for at least three months, including two patients (colon adenocarcinoma and mesothelioma) with stable disease lasting six months or longer.

Administration of XL765 at doses up to 60 mg BID has been generally well-tolerated, with no dose-limiting toxicities reported. At the maximum administered dose of 120 mg BID, dose-limiting toxicities included anorexia, hypophosphatemia, and reversible increases in liver enzyme levels. The preliminary maximum tolerated dose (MTD) is 60 mg BID, and dose ranging is ongoing to establish the MTD for both twice-daily and once-daily dosing regimens.

"The encouraging pharmacodynamic results in this trial are consistent with the target profile of XL765, and clearly demonstrate that XL765 inhibits both PI3K and mTOR in patients at doses that are well-tolerated," said Michael M. Morrissey, PhD, President of Research and Development at Exelixis. "We are very encouraged by these data, and believe they support the development of this compound both as a single agent and in combination with other anti-cancer agents."

"These positive data set the stage for possibly major advances toward the development of treatments for the many different cancers that involve the PI3K pathway," said Dr. Papadopoulos. "For perhaps the first time, we have seen inhibition of the PI3K pathway in humans, with good tolerability. The data suggest that XL765 has potential both alone and in combination with other therapies."

Phase 1b
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SOURCE Exelixis, Inc.
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