CARLSBAD, Calif., Feb. 9 /PRNewswire-FirstCall/ -- Isis Pharmaceuticals, Inc. today announced additional data from a clinical study of ISIS 301012 that supports an enhanced profile for the drug in treating patients with cardiovascular disease. In addition to previously reported significant reductions in both apoB-100 and LDL-C, ISIS 301012 also reduced serum triglycerides, achieving a median reduction of 46%. ISIS 301012, a second-generation antisense drug, inhibits apoB-100, a protein critical to the synthesis and transport of the "bad" cholesterol involved in heart disease -- low density lipoprotein cholesterol (LDL-C) and very low density lipoprotein (VLDL). Lowering cholesterol and triglyceride levels is a key component to the prevention and management of cardiovascular disease. These data will be presented at the Southwest Lipid Association Inaugural Meeting on February 11, 2006 in San Antonio, Texas by Mark Wedel, MD, JD, Senior Vice President of Development and Chief Medical Officer of Isis Pharmaceuticals.
As previously reported in the study, healthy volunteers with elevated cholesterol, who were treated with an average of 350 mg/week of ISIS 301012 for one month, achieved a median reduction of 60% in apoB-100 and median reduction of 54% in LDL-C. Importantly, ISIS 301012 also achieved a median reduction of 46% in serum triglycerides (reductions were statistically significant from placebo; p=0.005). These data are consistent with observations in other clinical studies conducted with ISIS 301012.
"Adding the reduction of triglycerides to the already strong profile of ISIS 301012 continues to enhance its potential value in treating patients with cardiovascular disease," Dr. Wedel said. "Having previously demonstrated statistically significant, dose-dependent reductions in LDL-C, we now have also reported significant and clinically important reductions in triglycerides in the same individuals. These results suggest that ISIS 301012 could be the first new lipid lowering drug with statin-like reductions in LDL-C that also significantly reduces triglyceride levels."
"High levels of triglycerides represent a risk factor for cardiovascular disease, especially in patients with type 2 diabetes," Dr. Wedel added. "Current drugs like statins reduce LDL-C, but have only a modest effect on triglyceride levels. Fibrates and niacin are more effective at lowering triglyceride levels but are less effective in lowering LDL-C. ISIS 301012 has shown the ability to reduce both LDL-C and triglyceride levels, which could further enhance the profile and add to the potential of ISIS 301012 as a new drug for treating patients with cardiovascular disease."
In September 2005, Isis initiated the Phase 2 development program of ISIS 301012. Phase 2 trials of ISIS 301012 are being conducted in patients with high cholesterol. Isis is conducting a Phase 2 single-agent trial designed to optimize dose and frequency of dosing, and to further evaluate the safety and efficacy of ISIS 301012 in patients with high cholesterol. Isis is also conducting a Phase 2 trial of ISIS 301012 in combination with statin therapy in patients with high cholesterol. Isis is also conducting Phase 2 studies of ISIS 301012 in patients with familial hypercholesterolemia (FH), a genetic disorder that causes extremely high cholesterol levels and results in the early onset of heart disease.
ABOUT CHOLESTEROL AND CARDIOVASCULAR DISEASE
According to the American Heart Association, an estimated 106.9 million American adults have total blood cholesterol values of 200 mg/dL and higher, and of these about 37.7 million American adults have levels of 240 or above. In adults, total cholesterol levels of 240 mg/dL or higher are considered "high risk". Levels from 200 to 239 mg/dL are considered "borderline-high risk". Low-density lipoprotein, or LDL, known as the "bad" cholesterol, can clog arteries, increasing the risk of heart attack and stroke.
According to the World Health Organization (WHO), heart disease and stroke kill 17 million people a year, which is almost one-third of all deaths globally. By 2020, the WHO projects that heart disease and stroke will become the leading cause of both death and disability worldwide, with the number of fatalities projected to increase to over 20 million a year and by 2030 to over 24 million a year.
Familial hypercholesterolemia is a dominantly inherited genetic condition that results in markedly elevated LDL (low-density lipoprotein) cholesterol levels beginning at birth, and resulting in heart attacks at an early age. Affected people have consistently high levels of low-density lipoprotein, which leads to premature atherosclerosis of the coronary arteries.
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 12 antisense drugs in development to treat metabolic, cardiovascular, ocular and inflammatory diseases, and cancer. In its Ibis division, Isis is developing and commercializing the TIGER 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 approximately 1,500 issued patents worldwide. Additional information about Isis is available at www.isispharm.com.
This press release includes forward-looking statements regarding the development, therapeutic potential and safety of ISIS 301012 to lower high cholesterol. Any statement describing Isis' goals, expectations, 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. 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, 2004, and its quarterly report on Form 10-Q for the quarter ended September 30, 2005, which are on file with the SEC. Copies of these and other documents are available from the Company.
Isis Pharmaceuticals, Inc.CONTACT: Navjot Rai, Investor Relations & Corporate Communications of IsisPharmaceuticals, Inc., +1-760-603-2331
Web site: http://www.isispharm.com/
