Isis Pharmaceuticals Initiates Phase 2 Study Of ISIS-CRP Rx In Patients With
CARLSBAD, Calif., Feb. 26, 2013
CARLSBAD, Calif., Feb. 26, 2013 /PRNewswire/ --Isis Pharmaceuticals, Inc.
(NASDAQ: ISIS) announced the initiation of a Phase 2 study evaluating
ISIS-CRP[Rx] in patients with paroxysmal atrial fibrillation.Atrial
fibrillation (AF) involves an irregular and often rapid heart rate that
commonly causes poor blood flow to the body. Paroxysmal AF is a type of AF
characterized by unpredictable episodes of AF that can occur as frequently as
every day.Patients with AF can experience chest palpitations, chest pain,
weakness and decreased blood pressure during an event.While the cause of
paroxysmal AF is not known, elevated levels of CRP are associated with an
increase in the severity of AF episodes. ISIS-CRP[Rx] is being evaluated in
patients with AF to measure the effect of lowering CRP on the frequency and
duration of the episodes.
"CRP is elevated in many inflammatory disorders and can also be elevated in
diseases with inflammatory components, like AF. Elevation of CRP in these
diseases is usually associated with increased disease burden and worse disease
outcome. In this study, we will evaluate the effect of selectively lowering
CRP on the severity of AF in patients who are prone to frequent and
unpredictable AF events. By selectively lowering CRP with ISIS-CRP[Rx], we
hope to observe a decrease in the frequency and duration of AF events in these
patients," said Richard Geary, Ph.D., senior vice president of development at
Isis. "ISIS-CRP[Rx] is the first drug to be evaluated in clinical studies that
can selectively reduce CRP. In our Phase 1 studies, we observed selective,
dose-dependent reduction of CRP in healthy volunteers. Our Phase 2 program is
designed to provide us with proof-of-concept data in diseases where elevated
levels of CRP are predictive of severity of disease."
The Phase 2 study is a randomized, placebo-controlled, multiple-dose study
evaluating the safety and efficacy of ISIS-CRP[Rx] as a single agent in
approximately 20 patients with AF who have pacemakers.The study is designed
to evaluate the effects of ISIS-CRP[Rx] on the frequency and duration of AF
episodes. In addition to studying ISIS-CRP[Rx ]in AF, Isis is also currently
evaluating ISIS-CRP[Rx] in a Phase 2 study in patients with rheumatoid
arthritis (RA), where CRP is chronically elevated.Top-line data from the
Phase 2 RA study is planned for the middle of this year.
"ISIS-CRP[Rx] is the first drug to test the hypothesis that lowering CRP
levels could produce therapeutic benefit to patients.Although we are
currently only evaluating ISIS-CRP[Rx] in patients with rheumatoid arthritis
and AF, if we are successful in demonstrating a significant benefit to
lowering CRP in one or both of these diseases, there is a significant
potential for ISIS-CRP[Rx] to have broad application in numerous diseases with
large commercial opportunity," concluded Lynne Parshall, chief operating
officer at Isis.
]ISIS-CRP[Rx] is an antisense drug that is designed to inhibit the production
of C-reactive protein (CRP). For many years, CRP has been used as a clinical
biomarker of diseases with an inflammatory component, such as cardiovascular
disease, Crohn's disease, RA and end-stage renal disease. Elevated levels of
CRP have been linked to coronary artery disease and a growing body of evidence
from clinical trials implicated CRP in cardiovascular disease progression.
Although CRP's active participation in these diseases remains to be
determined, several lines of evidence support a causal role of CRP in disease,
suggesting that it may be therapeutically beneficial to decrease CRP levels.
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 28 drugs to treat a wide variety of diseases with
an emphasis on cardiovascular, metabolic, severe and rare diseases, and
cancer. Isis' partner, Genzyme, is commercializing Isis' lead product,
KYNAMRO™, in the United States for the treatment of patients with HoFH.
Genzyme is also pursuing marketing approval of KYNAMRO in other markets,
including Europe. Isis' patents provide strong and extensive protection for
its drugs and technology. Additional information about Isis is available at
ISIS PHARMACEUTICALS' FORWARD-LOOKING STATEMENT
This press release includes forward-looking statements regarding the
development, activity, therapeutic potential and safety of ISIS-CRP[Rx]. Any
statement describing Isis' goals, expectations, financial or other
projections, intentions or beliefs, including the commercial potential 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.
Regulus Therapeutics™ is a trademark of Regulus Therapeutics 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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