Exelixis,
Inc. (Nasdaq: EXEL) today announced that it has suspended enrollment of new
patients in the XL999 clinical trial program until further data have been
collected and analyzed. The company currently anticipates that it will
incur a delay in the clinical program for XL999 of between two weeks and
three months. Exelixis suspended enrollment after a preliminary review of
patient data relating to cardiovascular adverse events for the month of
October. Through the end of September, 117 patients had been dosed with
XL999, of whom 12 (10.3%) experienced serious adverse cardiovascular
events. However, 4 of the 14 patients enrolled during October also
experienced such events, which raised a concern with the company's internal
safety monitoring committee. The company therefore decided to suspend
enrollment of new patients pending further review of the data. Because 115
of the 131 subjects enrolled in the XL999 clinical program to date have
received repeated doses of XL999 (every week or every other week) ranging
from 2 doses (2 weeks) to 53 doses (approximately 2 years) with no reported
cardiac toxicities, the company has elected to allow patients already
enrolled to continue to receive XL999.
"The apparent increase in the frequency of cardiovascular events during
October concerns us," said George A. Scangos, PhD, president and chief
executive officer of Exelixis. "These are recent observations, and we are
in the process of collecting and analyzing all of the relevant primary
data. Our primary responsibility is the safety of the patients in the
trial, and so we are suspending the enrollment of new patients until we
have had a chance to analyze the data. Since all but one of the events
occurred on first administration of XL999, we are continuing to treat those
patients presently enrolled in the trial. We will of course keep you
informed as we go forward analyzing the data."
Conference Call and Webcast
Exelixis' management will discuss recent developments involving the
XL999 clinical trial program and the company's third quarter 2006 financial
results as well as general business updates during a conference call
beginning at 2:00 p.m. PT/ 5:00 p.m. ET today, Thursday, November 2, 2006.
To listen to a webcast of the discussion, visit the Event Calendar page
under Investors at exelixis.
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 III (XL119, exclusively out-licensed to Helsinn
Healthcare S.A.), Phase II, and Phase I 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 anticipated two-week to
three-month delay with respect to the clinical program for XL999 and the
general clinical development plans for 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, the
potential failure to resume enrollment in the XL999 trial in a timely
manner; the potential failure of product candidates to demonstrate safety
and efficacy in clinical testing, which could prevent or significantly
delay regulatory approval; negative or inconclusive clinical trial results
may require Exelixis to conduct further testing, to modify clinical trial
protocols or to abandon trials; patient enrollment in the company's
clinical trials may be lower than anticipated, resulting in the delay or
cancellation of clinical testing; regulators or institutional review boards
may not authorize, delay, suspend or terminate clinical trials for various
reasons, including their determination that patients are being exposed to
unacceptable health risk; the degree of market acceptance of any of the
company's products in light of clinical trial results; the company's
ability to achieve milestone payments under its collaboration agreements;
the ability to conduct clinical trials sufficient to achieve a positive
completion; the uncertainty of the FDA approval process; and the
therapeutic and commercial value of the company's compounds. These and
other risk factors are discussed under "Risk Factors" and elsewhere in our
quarterly report on Form 10-Q for the quarter ended June 30, 2006 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.
Exelixis, Inc.
exelixis