Isis Initiates Phase 2 Study Of ISIS-FXIRX In Patients Undergoing Knee
CARLSBAD, Calif., Oct. 29, 2012
CARLSBAD, Calif., Oct. 29, 2012 /PRNewswire/ -- Isis Pharmaceuticals, Inc.
(NASDAQ: ISIS) announced the initiation of a Phase 2 comparator-controlled
study evaluating ISIS-FXI[Rx] in patients undergoing knee replacement surgery,
also referred to as total knee arthroplasty (TKA). ISIS-FXI[Rx] inhibits the
production of Factor XI, a coagulation factor produced in the liver that is
involved in the formation of clots. In this study, Isis will evaluate the
effectiveness of ISIS-FXI[Rx] in reducing the number of thrombotic events in
patients after TKA without increasing bleeding. The combination of robust
anti-thrombotic activity with an improved safety profile to currently
available anticoagulants could be broadly useful in many therapeutic settings
where thrombosis is a serious problem.
"Although there are a number of anti-coagulants on the market today that are
considered standard-of-care in multiple therapeutic settings, complications of
bleeding associated with these medications remain high and can lead to fatal
outcomes," said Harry Buller, Ph.D., M.D., professor of medicine at Academic
Medical Center in Netherlands. "Factor XI is an exciting target because it
plays a key role in the formation of clots but inhibiting it does not cause
bleeding. Humans who are deficient in Factor XI tend to have a lower
incidence of stroke and venous thrombosis with no evidence of spontaneous
The Phase 2 study is a global, multi-center, open-label, comparator-controlled
study in up to 400 patients who are undergoing TKA. The study will compare
ISIS-FXI[Rx] safety and activity to enoxaparin, a commonly used
anti-coagulant. In a Phase 1 study in healthy volunteers, ISIS-FXI[Rx]
produced robust dose-dependent, statistically significant reduction of greater
than 80 percent in Factor XI activity with no bleeding events observed.
"ISIS-FXI[Rx] is one of many maturing drugs in our pipeline and represents the
broad applicability of our technology to develop novel drugs for many
different diseases. We believe that the safety profile observed thus far
coupled with the robust activity we have seen for ISIS-FXI[Rx] in both our
Phase 1 study and preclinically, suggest that this drug could have a
significant benefit for patients at risk of a thrombotic event. Given the
mechanism of Factor XI inhibition, we believe that the drug could be used
broadly to prevent deep vein thrombosis or pulmonary embolism in many
different therapeutic settings, including stroke, myocardial infarction and
with surgeries such as knee or hip replacement, where additional safe and
effective anti-thrombotic drugs are needed. Our earlier work suggests that
ISIS-FXI[Rx] could be used in combination with existing therapies," said
Sanjay Bhanot, M.D., Ph.D., vice president, clinical development and
translational medicine at Isis.
"TKA is one of the leading surgeries performed worldwide each year and is
associated with a high incidence of venous thromboembolism," said Brett Monia,
Ph.D., senior vice president, antisense drug discovery at Isis. "By
evaluating our drug in these patients, we will be able to directly compare the
activity and safety of ISIS-FXI[Rx] to a commonly prescribed anti-coagulant,
enoxaparin. With this proof-of-value data in hand, we believe that we will
have a robust and comprehensive data package representing a significant
licensing opportunity for us."
ABOUT ISIS PHARMACEUTICALS, INC.
Isis is exploiting its leadership position in antisense technology to discover
and develop novel drugs for its product pipeline and for its partners. Isis'
broad pipeline consists of 25 drugs to treat a wide variety of diseases with
an emphasis on cardiovascular, metabolic, severe and rare diseases, and
cancer. Isis' partner, Genzyme, plans to commercialize Isis' lead product,
KYNAMRO™, following regulatory approval. Isis' patents provide strong and
extensive protection for its drugs and technology. Additional information
about Isis is available at www.isispharm.com.
ISIS PHARMACEUTICALS' FORWARD-LOOKING STATEMENT
This press release includes forward-looking statements regarding the
discovery, development, activity, therapeutic potential and safety of
ISIS-FXI[Rx]. Any statement describing Isis' goals, expectations, financial
or other projections, intentions or beliefs, including the planned
commercialization of KYNAMRO, is a forward-looking statement and should be
considered an at-risk statement. Such statements are subject to certain risks
and uncertainties, particularly those inherent in the process of discovering,
developing and commercializing drugs that are safe and effective for use as
human therapeutics, and in the endeavor of building a business around such
drugs. Isis' forward-looking statements also involve assumptions that, if
they never materialize or prove correct, could cause its results to differ
materially from those expressed or implied by such forward-looking
statements. Although Isis' forward-looking statements reflect the good faith
judgment of its management, these statements are based only on facts and
factors currently known by Isis. As a result, you are cautioned not to rely
on these forward-looking statements. These and other risks concerning Isis'
programs are described in additional detail in Isis' annual report on Form
10-K for the year ended December 31, 2011 and its most recent quarterly report
on Form 10-Q, which are on file with the SEC. Copies of these and other
documents are available from the Company.
In this press release, unless the context requires otherwise, "Isis,"
"Company," "we," "our," and "us" refers to Isis Pharmaceuticals and its
Isis Pharmaceuticals® is a registered trademark of Isis Pharmaceuticals, Inc.
KYNAMRO™ is a trademark of Genzyme Corporation.
SOURCE Isis Pharmaceuticals, Inc.
Contact: D. Wade Walke, Ph.D., Executive Director, Corporate Communications
and Investor Relations, +1-760-603-2741, or Amy Blackley, Ph.D., Associate
Director, Corporate Communications, +1-760-603-2772
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