Exelixis, Inc. (Nasdaq: EXEL) has been notified that the U.S. Food and Drug
Administration (FDA) has completed its review of a clinical trial protocol
for XL999 in patients with non-small cell lung cancer (NSCLC) and has
agreed that the trial may be initiated.
This clinical trial will evaluate XL999 in patients with NSCLC who have
failed at least one previous therapy. The trial will have a dose-escalation
format starting at 0.4 mg/kg dosed weekly, while monitoring patients for
potential cardiovascular events. Results from this Phase 1 clinical trial
could provide Exelixis with the opportunity to move directly into a late
stage clinical trial if XL999 demonstrates anti-tumor activity with an
acceptable side-effect profile in this well-defined NSCLC patient
population.
"We have worked closely with the FDA to reinitiate the clinical
development of XL999 and believe that the approved protocol will enable us
to assess both safety and preliminary anti-tumor activity of the compound
in patients with NSCLC," said George A. Scangos, PhD, president and chief
executive officer of Exelixis. "In the previous Phase 2 clinical trial of
XL999 in NSCLC patients, nine patients participated, of whom two had
partial responses and one had prolonged stable disease. We believe that
these data warrant further evaluation of XL999 in this patient population,
and we expect to begin enrolling patients in the new clinical trial this
summer."
About XL999
XL999 is a potent inhibitor of key receptor tyrosine kinases (RTKs)
implicated in the development and maintenance of tumor vasculature and in
the proliferation of some tumor cells. It inhibits the FGFR, VEGFR and
PDGFR RTKs and also is a potent inhibitor of FLT3, an important driver of
leukemia cell proliferation in some patients with acute myelogenous
leukemia (AML). Additional data from XL999 Phase 2 clinical trials will be
presented in a poster at the 43rd Annual Meeting of the American Society of
Clinical Oncology (ASCO). The conference is taking place June 1-5, 2007 in
Chicago.
XL999 was previously evaluated in Phase 1 and 2 clinical trials in
which cardiovascular adverse events were observed. These observations
caused Exelixis to suspend new patient enrollment in the ongoing XL999
clinical trials in November 2006. The FDA subsequently placed the clinical
program on partial clinical hold in December 2006. The previous Phase 1 and
2 clinical trials will not be re-initiated at this time. Given acceptance
by the FDA of the new clinical trial protocol for XL999 in patients with
NSCLC, the XL999 development program will now focus on this indication.
About Exelixis
Exelixis, Inc. is 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. The company is
leveraging its fully integrated drug discovery platform to fuel the growth
of its development pipeline, which is primarily focused on cancer.
Currently, Exelixis' broad product pipeline includes investigational
compounds in Phase 2 and Phase 1 clinical development for cancer and renal
disease. Exelixis has established strategic corporate alliances with major
pharmaceutical and biotechnology companies, including GlaxoSmithKline,
Bristol-Myers Squibb Company, Genentech, Wyeth Pharmaceuticals and Sankyo.
For more information, please visit the company's web site at
exelixis.
This press release contains forward-looking statements, including
without limitation statements related to the future development and
potential efficacy of XL999 and the expected timing of the initiation of
the clinical trial of XL999. Words such as "believes," "anticipates,"
"plans," "expects," "intends," "will," "slated," "goal" and similar
expressions are intended to identify forward-looking statements. These
forward-looking statements are based upon Exelixis' current expectations.
Forward-looking statements involve risks and uncertainties. Exelixis'
actual results and the timing of events could differ materially from those
anticipated in such forward-looking statements as a result of these risks
and uncertainties, which include, without limitation, risks related to the
lengthy, costly and uncertain process of clinical testing of XL999 and the
potential failure to demonstrate safety and efficacy and the therapeutic
and commercial potential of XL999. These and other risk factors are
discussed under "Risk Factors" and elsewhere in Exelixis' Annual Report on
Form 10-K for the year ended December 29, 2006 and other filings with the
Securities and Exchange Commission. Exelixis expressly disclaims any
obligation or undertaking to release publicly any updates or revisions to
any forward-looking statements contained herein to reflect any change in
Exelixis' expectations with regard thereto or any change in events,
conditions or circumstances on which any such statements are based.
Exelixis, Inc.
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