�Isis
Pharmaceuticals, Inc. (Nasdaq: ISIS) proclaimed it has initiated a
Phase 1 study of ISIS 353512, an antisense drug that inhibits the
production of C-reactive protein (CRP). CRP levels are frequently raised
in patients with a variety of diseases including cardiovascular disease,
Crohn's disease, rheumatoid arthritis and end-stage renal disease. The
Phase 1 sketch of ISIS 353512 is a blinded, randomized, placebo-controlled,
dose-escalation study designed to assess the safety and pharmacokinetic
profile of ISIS 353512 as well as to assess the initial effects of the drug
on baseline CRP levels in hefty volunteers. In addition, Isis is
design a blanket Phase 2 program to investigate multiple indications for
ISIS 353512.
"We consider that CRP plays an important causal role not only in
cardiovascular disease but likewise in renal and instigative diseases. Based
on our preclinical information, and the safety and pharmacological information we will
obtain from this cogitation, we plan to create a Phase 2 development plan that
evaluates several of the most scientifically and commercially attractive
indications for ISIS 353512," aforesaid Stanley Crooke, Chairman and Chief
Executive Officer of Isis. "CRP is an excellent illustration of the power of our
technology which enables us to efficiently develop drugs to any target and
to select targets that supply the most significant curative benefit in
disease areas where new treatment options are urgently needed."
ISIS 353512 Targets CRP
ISIS 353512 is an antisense dose that targets CRP. For many days, CRP
has been used as a clinical biomarker of diseases with an inflammatory
factor, such as cardiovascular disease, Crohn's disease, rheumatoid
arthritis 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 implicates CRP in cardiovascular disease progression.
Although CRP's active engagement 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 good to decrease
CRP levels in patients who ar at danger for coronary thrombosis events. In addition,
elevated CRP levels have been associated with a worsening of overall
outcome in conditions such as end-stage renal disease, suggesting that
lowering CRP in these patients would be good. In presymptomatic studies,
ISIS 353512 produced dramatic suppression of liver and serum CRP levels.
ABOUT ISIS PHARMACEUTICALS, INC.
Isis is exploiting its expertness in RNA to light upon and develop novel
drugs for its product line and for its partners. The Company has
successfully commercialized the world's number one antisense dose and has 18
drugs in development. Isis' dose development programs are focused on
treating cardiovascular and metabolic diseases. Isis' partners are
development antisense drugs invented by Isis to treat a wide variety of
diseases. Ibis Biosciences, Inc., Isis' majority-owned subsidiary company, is
development and commercializing the Ibis T5000(TM) Biosensor System, a
revolutionary system to identify infectious organisms. Isis is a joint
owner of Regulus Therapeutics LLC, a joint speculation focused on the
discovery, development and commercialization of microRNA therapeutics. As
an innovator in RNA-based do drugs discovery and development, Isis is the owner
or exclusive licensee of over 1,D issued patents worldwide. Additional
information about Isis is available at http://www.isispharm.com.
This press out release includes forward-looking statements regarding Isis'
discovery and development of drugs for cardiovascular diseases, and the
potential of the antisense drug ISIS 353512 to treat cardiovascular, renal
and inflammatory diseases. Any command describing Isis' goals,
expectations, financial or other projections, intentions or beliefs is a
modern statement and should be considered an at-risk statement,
including those statements that are described as Isis' goals. Such
statements ar subject to certain risks and uncertainties, particularly
those inherent in the serve of discovering, developing and
commercializing drugs that ar safe and effective for use as human
therapeutics, and in the effort of building a line around such
products. Isis' forward-looking statements also involve assumptions that,
if they never happen or evidence correct, could cause its results to
differ materially from those expressed or implied by such forth looking
statements. Although Isis' forward-looking statements reflect the good
religion judgment of its management, these statements are based only on facts
and factors currently known by Isis. As a answer, you ar cautioned non to
swear 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 yr ended December 31, 2007, and its quarterly report on
Form 10-Q for the quarter ended June 30, 2008, which are on file with the
SEC. Copies of these and early documents are available from the Company.
In this press waiver, unless the context requires otherwise, "Isis,"
"Company," "we," "our," and "us" refers to Isis Pharmaceuticals and its
subsidiaries.
Isis Pharmaceuticals is a registered trademark of Isis Pharmaceuticals,
Inc. Ibis Biosciences and Ibis T5000 are trademarks of Ibis Biosciences,
Inc. Regulus Therapeutics is a trademark of Regulus Therapeutics LLC.
Isis Pharmaceuticals, Inc.
http://www.isispharm.com
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