Press Releases
Isis Pharmaceuticals Initiates Phase 3 Study of ISIS-APOCIII Rx in Patients with FCS
CARLSBAD, Calif.,
"FCS is a rare and very serious genetic disorder that is often associated with triglyceride levels higher than 2,000 mg/dL. Because of their extremely high triglyceride levels, FCS patients are at significant risk of many serious health conditions, including frequent episodes of pancreatitis, which can require hospitalization and can be life-threatening. Current treatment options do not reduce triglyceride levels enough to reduce the risk of serious illness in patients with FCS," said
In a Phase 2 study, FCS patients treated with ISIS-APOCIIIRx experienced decreases in triglycerides of up to more than 1,500 mg/dL. Isis has also evaluated ISIS-APOCIIIRx in a broad Phase 2 program. In these studies in patients with very high to extremely high triglyceride levels, patients treated with ISIS-APOCIIIRx achieved substantial lowering of triglycerides (mean percent reductions of up to 71%) and apoC-III (mean percent reductions of up to 88%) and increasing of HDL-cholesterol (mean percent increases of up to 78%).
"Our focus is to bring ISIS-APOCIIIRx to the market for patients with severely elevated triglycerides. These patients are at significant health risk because they cannot reduce their triglycerides to safe levels with currently available medicines. We are pleased with the data from our Phase 2 program in which substantial triglyceride lowering was achieved when ISIS-APOCIIIRx was dosed as a single agent or in combination with fibrates in patients with a wide range of incoming triglycerides, including FCS patients," said
ISIS-APOCIIIRx is designed to target apoC-III, a protein produced in the liver that plays a central role in the regulation of serum triglycerides. ApoC-III is a genetically validated target for lowering triglycerides. Independent studies have demonstrated a link between lower apoC-III activity, which results in lower triglyceride levels, and reduced cardiovascular disease.
In addition to developing ISIS-APOCIIIRx for patients with FCS, Isis is also developing ISIS-APOCIIIRx for patients with severely elevated triglycerides, greater than 880 mg/dL, a condition that affects an estimated 50,000 patients in
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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 discovery, development, and potential of drugs for cardiovascular diseases, and the development, activity, therapeutic potential and safety of ISIS-APOCIIIRx. 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
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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