Press Releases
Drugs from Isis' Lipid Franchise Highlighted at European Society of Cardiology Congress 2014
- A retrospective analysis of data from a long-term extension study of KYNAMRO® (mipomersen sodium) injection. In this analysis patients with heterozygous familial hypercholesterolemia (HeFH) and homozygous familial hypercholesterolemia (HoFH) treated for one year with KYNAMRO experienced a reduction in Major Adverse Cardiovascular Events (MACE) from 25.72/1000 months (in the two years prior to KYNAMRO® treatments) to 4.85/1000 months.
- An overall summary of the Phase 2 program for ISIS-APOCIIIRx in which treatment with ISIS-APOCIIIRx produced consistent, robust and statistically significant reductions in triglycerides, apoC-III and non-HDL and increases in HDL-cholesterol in all patient populations evaluated.
- Data from the Phase 1 study of ISIS-APO(a)Rx in which treatment with ISIS-APO(a)Rx produced dose-dependent and significant reductions in Lp(a) levels in healthy volunteers.
In two invited presentations, Dr.
"The statistical significant decrease in rate of MACE in patients treated with KYNAMRO represents an important finding and complements the therapeutic profile of KYNAMRO," said Dr. Kastelein. "These results are encouraging and support the potential for therapeutic benefit in patients with homozygous FH, the most aggressive form of familial hypercholesterolemia."
In one of the invited presentations, Dr. Kastelein also provided an overview of the results from the Phase 2 program for ISIS-APOCIIIRx, a novel triglyceride-lowering drug. Isis is currently evaluating ISIS-APOCIIIRx in a Phase 3 study in patients with familial chylomicronemia syndrome (FCS) and plans to initiate additional Phase 3 studies in patients with severely elevated triglycerides, including patients with triglyceride levels greater than 880 mg/dL. In the Phase 2 program, in all patient groups studied, irrespective of their incoming triglyceride levels, treatment with ISIS-APOCIIIRx consistently reduced apoC-III by up to 88 percent, triglycerides by up to 71 percent, and increased HDL-cholesterol by up to 78 percent, with a positive effect on non-HDL. In all of the clinical studies, ISIS-APOCIIIRx had a tolerability profile supportive of continued development. In addition, the final data analysis from the Phase 2 study evaluating ISIS-APOCIIIRx as a single agent in patients with very high to severely high triglycerides was presented by Dr.
In a separate presentation, Dr.
ABOUT
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 32 drugs to treat a wide variety of diseases with an emphasis on cardiovascular, metabolic, severe and rare diseases, including neurological disorders, and cancer. Isis' partner, Genzyme, is commercializing Isis' lead product, KYNAMRO®, in
This press release includes forward-looking statements regarding the development, activity, therapeutic benefit, safety and commercial potential of KYNAMRO in treating patients with homozygous FH and the discovery, development, activity, therapeutic potential and safety of ISIS-APOCIIIRx and ISIS-APO(a)Rx. 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 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
In this press release, unless the context requires otherwise, "Isis," "Company," "we," "our," and "us" refers to
Isis Pharmaceuticals® is a registered trademark of
Logo - http://photos.prnewswire.com/prnh/20130807/LA60006LOGO
SOURCE
D. Wade Walke, Ph.D., Vice President, Corporate Communications and Investor Relations, 760-603-2741; Amy Blackley, Ph.D., Associate Director, Corporate Communications, 760-603-2772