IND Filed for XL820, a Novel Anticancer Compound
Apr 26, 2005 - 12:06:38 PM

Exelixis, Inc. (Nasdaq: EXEL - News) has submitted an investigational new drug application (IND) to the U.S. Food and Drug Administration (FDA) for XL820. This novel small molecule anticancer compound potently inhibits receptor tyrosine kinases (RTKs) implicated in tumor proliferation and vascularization. XL820 is the fifth compound to advance in clinical development from Exelixis' internal drug discovery capabilities. Pending clearance by the FDA, Exelixis intends to initiate a Phase I clinical trial for XL820.

"I am very enthusiastic about the continued productivity of our R&D groups. We filed three INDs last year, and XL820 is the first of three anticipated INDs for this year. We believe these compounds are high quality and have the potential to provide substantial therapeutic benefit to patients in need," said George A. Scangos, Ph.D., president and chief executive officer of Exelixis. "Before the end of 2005, we anticipate having eight compounds in clinical development, each of which potentially represents an important therapeutic advance."

XL820 inhibits the VEGF receptor, KIT and the PDGF receptor, which are clinically validated targets implicated in a variety of human cancers. XL820 exhibits dose-dependent growth inhibition in models of breast carcinoma, gliomas and leukemia. In an animal model of more advanced malignancy, significant tumor regression was seen. In non-clinical studies, XL820 has shown good oral bioavailability and sustained inhibition of target RTKs in vivo following a single oral dose.

Spectrum Selective Kinase Inhibitor(TM) (SSKI) Program

Exelixis' SSKI Program is focused on the development of compounds that are optimized to specifically target kinases implicated in tumor cell proliferation and angiogenesis thereby providing the potential for more potent therapeutic effects. The company currently has three compounds in active Phase I trials, which are XL647, XL999 and XL880, that came out of this program. Exelixis anticipates that it will complete the Phase I trials for XL647 and XL999 in the second half of 2005 and to initiate broad Phase II trial programs for these compounds as soon as practicable thereafter. The Phase I trial for XL880 was initiated in March and is actively enrolling patients. Exelixis is continuing to expand its SSKI Program by advancing additional diverse, high-quality compounds into clinical development, including XL844 and XL184 for which IND filings are anticipated in the first half of 2005, and has also made progress on earlier-stage compounds that are part of the SSKI Program.

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