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Isis Reports That ISIS 301012 Is Well Tolerated In Patients Treated For Five Or More Months
Isis
Pharmaceuticals, Inc. (Nasdaq: ISIS) announced the first safety results
from its ongoing Phase 2 open-label extension (OLE) study of ISIS 301012 in
patients with familial hypercholesterolemia (FH) on stable maximally
tolerated lipid-lowering therapies. In addition, yesterday Isis announced
results from a placebo-controlled Phase 2 study of ISIS 301012 in patients
with heterozygous FH that were presented in a poster session at the
Drugs Affecting Lipid Metabolism (DALM) XVI International Symposium in New
York City. Collectively, these results will be presented by Dr. John J.P.
Kastelein in an oral session at DALM on Saturday at 3:45 p.m. E.T., and
Isis will host a conference call Monday morning at 8:00 a.m. E.T. to
discuss the results.
The ongoing Phase 2 OLE study includes 16 FH patients who had completed
one of Isis' initial Phase 2 studies in FH patients and who subsequently
enrolled in this open-label extension study. ISIS 301012 continues to be
well tolerated by these patients with extended exposures and in the
presence of continued maximally tolerated lipid-lowering therapies. As of
September 17, four patients had received more than six months of weekly
doses of ISIS 301012 over the course of both initial and OLE studies, and
12 of the 16 patients had total exposures of approximately five months or
more. No new types of adverse events were observed with extended dosing or
repeat exposures, no worsening of injection site reactions, and no increase
in the frequency or severity of liver transaminase elevations.
John J.P. Kastelein, M.D., Ph.D., Chairman, Department of Vascular
Medicine at the Academic Medical Center in Amsterdam, The Netherlands, also
a principal investigator for the studies, commented, "We are particularly
pleased to have had such an uneventful experience with patients in the
long-term study. Until now, the longest exposures to ISIS 301012 had been
three months, and now to have patients dosed for a total of more than six
months without any tolerability issues is quite reassuring. Of course, we
will all be eager to see more patients and longer exposure times to
strengthen our confidence that ISIS 301012 could truly be a
transformational new drug for the treatment of refractory high
cholesterol."
About ISIS 301012 and Cholesterol
ISIS 301012 is a second-generation antisense drug that reduces the
production of apoB-100, a protein critical to the synthesis and transport
of "bad" cholesterol and a target that has proved to be undruggable using
traditional, small-molecule approaches. Cholesterol can be carried in the
bloodstream in a variety of forms, with high-density lipoprotein, or HDL-C,
being the good form, and low-density lipoproteins, or LDL-C, and very
low-density lipoproteins, or VLDL-C, being bad forms directly involved in
heart disease. Collectively, LDL-C, VLDL-C, and other bad forms of
cholesterol are referred to as "non-HDL-C." The lowering of non-HDL-C is a
key component in the prevention and management of cardiovascular disease.
Isis plans to develop ISIS 301012 as the drug of choice for patients who
are unable to achieve target cholesterol levels with statins alone or who
are intolerant of statins. For future studies, including the registration
studies for FH and the long-term coadministration study planned for
patients with routine high cholesterol, both expected to begin this year,
Isis has selected 200 mg/week as its development dose.
About Familial Hypercholesterolemia
Familial hypercholesterolemia is a genetic condition that results in
markedly elevated LDL-C levels beginning at birth and heart attacks at an
early age. People with the disease have consistently high levels of LDL-C,
which leads to premature atherosclerosis of the coronary arteries. Current
therapies for FH are inadequate, and the most severely affected patients
may need apheresis, an expensive and time-consuming procedure that removes
the "bad" cholesterol from the blood. Homozygous FH is rare, affecting
about one in one million people, but heterozygous FH is much more common
with a prevalence of approximately one in every 500 people.
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 17
drugs in development. Isis' drug development programs are focused on
treating cardiovascular and metabolic diseases. Isis' partners are
developing drugs for a wide variety of diseases. Ibis Biosciences, Inc.,
Isis' wholly owned subsidiary, is developing and commercializing the Ibis
T5000(TM) Biosensor System, a revolutionary system to identify infectious
organisms. As an innovator in RNA-based drug discovery and development,
Isis is the owner or exclusive licensee of over 1,500 issued patents
worldwide. Additional information about Isis is available at
http://www.isispharm.com.
This press release includes forward-looking statements regarding the
development, activity, therapeutic potential and safety of ISIS 301012 in
treating patients with high cholesterol. 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, including those statements that are described as Isis' goals or
projections. 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, in developing and commercializing systems to identify
infectious organisms that are effective and commercially attractive, 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, 2006, and its quarterly report on Form
10-Q for the quarter ended June 30, 2007, which are 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.
Isis Pharmaceuticals, Ibis Biosciences and Ibis T5000 are registered
trademarks or trademarks of Isis Pharmaceuticals, Inc.
Isis Pharmaceuticals, Inc.
http://www.isispharm.com
Isis Rapoarte ISIS 301012 Asta este bine tolerat la pacienþii trataþi pentru cinci sau mai multe luni - Isis Reports That ISIS 301012 Is Well Tolerated In Patients Treated For Five Or More Months - articole medicale engleza - startsanatate