WASHINGTON and CARLSBAD, Calif., May 1 /PRNewswire-FirstCall/ -- Isis
Pharmaceuticals, Inc. (Nasdaq: ISIS) announced today that Isis and
collaborators presented data on numerous advanced programs from Isis'
cardiovascular franchise. The data were presented during the
Arteriosclerosis, Thrombosis and Vascular Biology's (ATVB) Annual Conference.
The presentations included data from a post-hoc analysis of a recently
completed clinical study of mipomersen in which treatment with mipomersen
resulted in a decrease in apoC-III. In addition, Isis presented preclinical
data from two late-stage research programs, one on a direct antisense
inhibitor of apoC-III, which may provide a promising new drug to lower
triglycerides, and a second on an antisense inhibitor to Factor XI, which has
the potential to create a drug to decrease clotting without increasing
bleeding. Both of these programs are expected to produce near-term clinical
development candidates that have the potential to provide unique treatments
for cardiovascular disease. Isis and collaborators also presented data on
antisense inhibitors against 11 beta-HSD1 and apoF, potential new
cardiovascular targets. The research presented at this year's ATVB in
Washington D.C. showcases Isis' prolific antisense drug discovery capabilities
and supports the continued expansion of Isis' cardiovascular franchise.
At ATVB, Isis collaborator, Dr. Frank Sacks, Professor of Cardiovascular
Disease Prevention at the Harvard School of Public Health, presented a
post-hoc analysis on a Phase 2 study in patients with high cholesterol who
were treated with mipomersen as a single agent. Dr. Sacks' analysis showed
that treatment with mipomersen reduced circulating apoC-III. ApoC-III is an
apolipoprotein that transports triglycerides in the blood. Patients with
cardiovascular disease frequently have elevated levels of triglycerides and
apoC-III.
Isis scientist, J. Crosby, presented new research titled "Antisense
oligonucleotide-mediated depletion of Factor XI results in effective
anticoagulation with a favorable risk/benefit profile in mice" demonstrating
that antisense drugs that inhibit Factor XI can prevent thrombus formation in
models of stroke without causing an increase in bleeding, the most common side
effect observed with currently available antithrombotic agents. The Isis
antisense drug inhibiting Factor XI is in advanced research and representative
of significant advances in creating antisense drugs that can more safely
reduce undesired clotting.
"Factor XI is the first representative drug candidate for development from
our new thrombosis effort. It is another example of the power of our
antisense technology to develop new drugs to nearly any genomic target," said
Brett Monia, Ph.D., Vice President of Drug Discovery and Corporate Development
at Isis Pharmaceuticals. "After rapidly and efficiently evaluating individual
clotting factors produced in the liver, we selected Factor XI as the optimal
target to inhibit thrombosis without causing bleeding. In addition to Factor
XI, we will have drugs that inhibit other individual clotting factors that
demonstrate potential therapeutic benefit and represent other novel approaches
to treating cardiovascular disease."
Isis scientist, A. Mullick, also presented new research titled "Antisense
inhibition of apolipoproteinC-III mitigated features of metabolic syndrome and
reduced atherosclerosis in LDL receptor knockout mice" showing the ability of
antisense drugs in a late-stage research program targeting apoC-III to
selectively reduce triglycerides in both liver and blood. Antisense drugs
that selectively reduced levels of apoC-III dramatically reduced triglycerides
and atherosclerosis in animal models.
"The potential to add an apoC-III inhibitor in the near-term to our
cardiovascular pipeline, which already includes mipomersen, a CRP inhibitor
and a PCSK9 inhibitor is quite exciting," said Richard Geary, Ph.D., Senior
Vice President of Development at Isis Pharmaceuticals. "Inhibiting apoC-III
is a promising new way to lower triglycerides to treat a potential independent
risk factor for cardiovascular disease. Futhermore, the anti-atherotic effect
of lowering apoC-III, which we have seen in animals, suggests that lowering
apoC-III could produce reductions in atherosclerosis in man as well."
Finally, Isis and collaborators reported on the effects of antisense drugs
targeting 11 beta-HSD1 and apoF. In a presentation titled "Antisense-mediated
inhibition of 11 beta-HSD1 significantly decreases hepatic lipogenesis,
triglyceride content and triglyceride secretion" Isis collaborator, G. Li from
Columbia University, showed that antisense inhibition of 11 beta-HSD1 reduced
triglycerides in both liver and blood, while also reducing body fat in animal
models. 11 beta-HSD1 is an enzyme that inactivates steroids and may
contribute to metabolic disease, suggesting the potential therapeutic benefit
of antisense drugs inhibiting 11 beta-HSD1 to treat high triglycerides and
diabetes. In a presentation titled "In vivo knock down of apolipoprotein F
decreases liver triglyceride levels" S. Khetarpal from University of
Pennsylvania presented research demonstrating that antisense drugs that
selectively inhibit apoF reduced triglycerides in blood and liver. ApoF is
another protein that carries triglycerides in blood and could offer potential
therapeutic benefit in patients with diseases associated with elevated
triglycerides including cardiovascular disease.
"The efficiency of our drug discovery platform offers us virtually
unlimited opportunities to expand the scope of diseases we can treat with
antisense drugs. We have shown that antisense inhibition of a number of new
disease targets could have potential therapeutic benefits across a wide range
of cardiovascular diseases," said C. Frank Bennett, Ph.D., Senior Vice
President of Research at Isis Pharmaceuticals. "The work we presented at this
year's ATVB conference demonstrates the broad applicability of our technology
and how we can take advantage of the growing number of genetically identified
therapeutic targets, especially targets associated with cardiovascular
disease. Of course, we see similar efficiency and equally exciting advances
in therapeutic areas outside of cardiovascular disease, including severe
neurodegenerative and metabolic diseases, and cancer."
ABOUT ISIS PHARMACEUTICALS, INC.
Isis is exploiting its expertise in RNA to discover and develop novel
drugs for its product pipeline and for its partners. The Company has
successfully commercialized the world's first antisense drug and has 19 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 variety of diseases. Isis
and Alnylam Pharmaceuticals are joint owners of Regulus Therapeutics Inc., a
company focused on the discovery, development and commercialization of
microRNA therapeutics. Isis also has made significant innovations beyond
human therapeutics resulting in products that other companies, including
Abbott, are commercializing. As an innovator in RNA-based drug discovery and
development, Isis is the owner or exclusive licensee of over 1,600 issued
patents worldwide. Additional information about Isis is available at
www.isispharm.com.
This press release includes forward-looking statements regarding Isis'
business, its drug discovery and development pipeline, and the therapeutic
potential of antisense drugs for the treatment of cardiovascular disease. Any
statement describing Isis' goals, expectations, financial or other
projections, intentions or beliefs 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 products. 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, 2008, which is on file with the SEC.
Copies of this 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
subsidiaries, including Regulus Therapeutics Inc.
Isis Pharmaceuticals is a registered trademark of Isis Pharmaceuticals,
Inc. Regulus Therapeutics is a trademark of Regulus Therapeutics Inc.
SOURCE Isis Pharmaceuticals, Inc.
-0- 05/01/2009
/CONTACT: Kristina Lemonidis, Director, Investor Relations,
+1-760-603-2490, or Amy Blackley, Ph.D., Assistant Director, Corporate
Communications, +1-760-603-2772, both of Isis Pharmaceuticals, Inc./
/Web Site: http://www.isispharm.com /
(ISIS)
CO: Isis Pharmaceuticals, Inc.
ST: District of Columbia, California
IN: HEA MTC PHA
SU: TDS TRI
PR
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2354 05/01/2009 09:00 EDT http://www.prnewswire.com
