Exelixis, Inc. (ticker: EXEL, exchange: NASDAQ Global Market (.O))
News Release -
Exelixis Files IND Application for Anticancer Compound XL999
SOUTH SAN FRANCISCO, Calif., June 29 /PRNewswire-FirstCall/ -- Exelixis,
Inc. (Nasdaq: EXEL) has submitted an investigational new drug application
(IND) to the U.S. Food and Drug Administration (FDA) for XL999, a proprietary
novel anticancer compound. Preclinical studies with XL999 have demonstrated
potent inhibition in vivo against multiple receptor tyrosine kinases (RTKs)
that are implicated in tumor angiogenesis, or the development and maintenance
of tumor vasculature. Pending clearance by the FDA, the company intends to
initiate a Phase 1 clinical trial.
XL999 is one of several Spectrum Selective Kinase Inhibitors(TM) (SSKI) in
Exelixis' product pipeline. Each SSKI has a different RTK inhibition spectrum,
and each has the potential to achieve efficacy through simultaneous inhibition
of multiple RTKs. Preclinical studies have shown that XL999 simultaneously
inhibits the FGFR, VEGFR, PDGFR and Flt3 RTKs with high levels of potency and
demonstrates excellent activity in target-specific cellular functional assays.
XL999 has demonstrated potent anti-tumor activity in a variety of preclinical
models of solid tumors as well as a Flt3-driven model of leukemia.
"This IND application is the second we have filed this year, which is the
direct result of the productivity of our R&D groups," said George A. Scangos,
Ph.D., president and chief executive officer. "Together with XL119, which
recently began a pivotal Phase 3 study, XL784, which has successfully
completed a Phase 1 study, XL647, which has begun a Phase 1 study, and a rich
portfolio of pre-clinical development compounds, XL999 is part of a growing,
high-quality pipeline of compounds that we intend to advance rapidly into and
through clinical trials. Our goal is to leverage our significant expertise in
biology, drug discovery, and development to generate a diverse portfolio of
anti-cancer compounds with substantial therapeutic and commercial potential.
This IND application is one more sign that we are executing on our vision of
becoming a major cancer therapeutics company."
The Phase 1 clinical trial of XL999 will be an open-label, dose escalation
study conducted in cancer patients. The study is designed to measure the
safety, tolerability, pharmacokinetics, pharmacodynamics and biological
activity of XL999 following a single intravenous administration. The study
will be conducted at a major medical center in the United States.
Pursuant to a product development and commercialization agreement between
Exelixis and GlaxoSmithKline (GSK), GSK has the option, after completion of
Phase 2a clinical trials, to elect to develop a certain number of the cancer
compounds in Exelixis' product pipeline (other than the company's cancer
compound XL119), which may include XL999, thus potentially triggering
milestone payments and royalties from GSK and co-promotion rights by Exelixis.
Exelixis, Inc. is a leading genomics-based drug discovery company
dedicated to the discovery and development of novel therapeutics. The company
is leveraging its fully integrated gene-to-drug platform to fuel the growth of
its proprietary drug pipeline. Exelixis' development pipeline includes:
XL119 (becatecarin), for which a Phase 3 clinical trial has been initiated in
patients with bile duct tumors; XL784, which has completed a Phase 1 clinical
trial; XL647, which is currently in a Phase 1 clinical trial; XL999 for which
an IND has been filed; XL844, XL820 and XL880, anticancer compounds that are
potential IND candidates; and multiple compounds in preclinical development.
Exelixis has established broad corporate alliances with major pharmaceutical
and biotechnology companies, including GSK and Bristol-Myers Squibb Company.
The company has also established agricultural research collaborations with
Bayer CropScience, Dow AgroSciences and Renessen LLC. Other partners include
Merck & Co., Inc., Schering-Plough Research Institute, Inc., Cytokinetics,
Inc., Elan Pharmaceuticals, Inc. and Scios Inc. For more information, please
visit the company's web site at www.exelixis.com.
This press release contains forward-looking statements, including without
limitation all statements related to plans to advance XL999 into clinical
development, and the therapeutic and commercial potential of XL647, XL119,
XL999, XL844, XL820, XL880 and other compounds in Exelixis preclinical
pipeline. Words such as "believes," "anticipates," "plans," "expects,"
"intend," "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 ability of the company to
successfully advance and develop XL999 and other preclinical compounds, the
ability of the company to successfully conduct the Phase 1 clinical trial of
XL647 and the Phase 3 clinical trial of XL119, and to initiate the Phase 1
clinical trial of XL999 later in 2004, and the uncertainty of the FDA approval
process with respect to and commercial value of these and other compounds in
the company's pipeline. These and other risk factors are discussed under "Risk
Factors" and elsewhere in our quarterly report on Form 10-Q for the quarter
ended March 31, 2004 and other filings with the Securities and Exchange
Commission. The company 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 the company's expectations with
regard thereto or any change in events, conditions or circumstances on which
any such statements are based.
NOTE: Exelixis and the Exelixis logo are registered U.S. trademarks.
Spectrum Selective Kinase Inhibitor is a trademark of Exelixis, Inc.
SOURCE Exelixis, Inc.
/CONTACT: Jane M. Green, Ph.D., VP, Corporate Communications of Exelixis,
Inc., +1-650-837-7579, or firstname.lastname@example.org/
/Web site: http://www.exelixis.com /
CO: Exelixis, Inc.; U.S. Food and Drug Administration
IN: BIO MTC HEA
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9612 06/29/2004 06:00 EDT http://www.prnewswire.com