�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 ar 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 study 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 goodish volunteers. In addition, Isis is
design a unspecific Phase 2 program to investigate multiple indications for
ISIS 353512.
"We conceive that CRP plays an important causal role not only in
cardiovascular disease but likewise in renal and inflammatory diseases. Based
on our preclinical data, and the safety and pharmacological information we will
obtain from this study, we plan to create a Phase 2 development plan that
evaluates various 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 exercise of the power of our
applied science which enables us to efficiently develop drugs to any fair game and
to select targets that provide the most significant therapeutical benefit in
disease areas where new treatment options are desperately needed."
ISIS 353512 Targets CRP
ISIS 353512 is an antisense do drugs that targets CRP. For many eld, CRP
has been used as a clinical biomarker of diseases with an inflammatory
component, 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 involvement in these diseases stiff to be
determined, several lines of evidence support a causal role of CRP in
disease, suggesting that it may be therapeutically beneficial to decrement
CRP levels in patients who are at risk of exposure for coronary events. In addition,
elevated CRP levels have been associated with a worsening of boilers suit
outcome in conditions such as end-stage renal disease, suggesting that
lowering CRP in these patients would be beneficial. In presymptomatic studies,
ISIS 353512 produced dramatic crushing of liver and blood serum CRP levels.
ABOUT ISIS PHARMACEUTICALS, INC.
Isis is exploiting its expertise in RNA to happen upon and acquire novel
drugs for its product pipeline and for its partners. The Company has
successfully commercialized the world's first antisense drug and has 18
drugs in development. Isis' drug development programs are focused on
treating cardiovascular and metabolic diseases. Isis' partners are
developing antisense drugs invented by Isis to treat a wide mixed bag of
diseases. Ibis Biosciences, Inc., Isis' majority-owned foot soldier, 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 venture focused on the
find, 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 all over 1,five hundred issued patents worldwide. Additional
information around 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 affirmation describing Isis' goals,
expectations, financial or other projections, intentions or beliefs is a
forward-looking statement and should be considered an at-risk affirmation,
including those statements that are described as Isis' goals. Such
statements are subject to certain risks and uncertainties, particularly
those inherent in the march of discovering, developing and
commercializing drugs that are safe and effective for use as human
therapeutics, and in the enterprise of building a business sector around such
products. Isis' forward-looking statements also imply assumptions that,
if they never materialize or prove correct, could cause its results to
differ materially from those expressed or implied by such fore looking
statements. Although Isis' forward-looking statements reflect the good
faith judgment of its management, these statements are based only on facts
and factors presently known by Isis. As a resultant role, you are cautioned not to
trust on these forward-looking statements. These and other risks concerning
Isis' programs are described in additional detail in Isis' annual story on
Form 10-K for the class ended December 31, 2007, and its quarterly account on
Form 10-Q for the quarter ended June 30, 2008, which ar on file with the
SEC. Copies of these and early 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
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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