CARLSBAD, CA, USA I April 3, 2013 I Isis Pharmaceuticals, Inc. (ISIS) announced today that it has initiated a Phase 1 clinical study for ISIS-APOA, an antisense drug targeting apolipoprotein(a) for the treatment of atherosclerosis. Apolipoprotein(a) contributes to the formation of plaque in arteries through its attachment to an LDL-C particle in a complex termed lipoprotein(a), or Lp(a). High levels of Lp(a) are associated with an increased risk of atherosclerosis, coronary heart disease, heart attack and stroke. ISIS-APOARx is designed to reduce Lp(a) by inhibiting the production of apolipoprotein(a). Isis plans to develop ISIS-APOARx to treat patients with high Lp(a) levels who are at high risk of experiencing cardiovascular events.
“Lp(a) is an independent risk factor for coronary heart disease. Although Lp(a) can be measured during a routine lipid blood panel, the lack of drugs that effectively lower Lp(a) have made treating patients with high Lp(a) levels difficult. Because elevated Lp(a) is an inherited genetic condition, patients are unable to adequately control their Lp(a) levels through diet or lifestyle changes. By inhibiting the production of apolipoprotein(a), ISIS-APOARx is designed to reduce the levels of Lp(a), thereby offering a unique and specific approach to treating patients who have high cardiovascular risk due to high Lp(a) levels,” said Walter Singleton, M.D., vice president of development and chief medical officer at Isis. “ISIS-APOARx is part of Isis’ strategy to create a cardiovascular disease franchise comprised of drugs that target all the key components of cardiovascular disease, including various atherogenic lipids, inflammation and thrombosis.”
The Phase 1 study of ISIS-APOARx is a blinded, placebo-controlled, dose-escalation study in approximately 56 healthy volunteers. The study is designed to assess the safety, tolerability and pharmacokinetics of both single and multiple doses of ISIS-APOARx.
ABOUT Lp(a)
Lp(a) is considered an independent risk factor for cardiovascular disease due to its association with an increased risk of coronary heart disease and atherosclerotic plaque formation. Lp(a) is a lipoprotein particle that is assembled in the liver that consists of an LDL-C-like particle and apolipoprotein(a). Lp(a) levels in blood can vary greatly between individuals due primarily to genetic variations in the gene that encodes for apolipoprotein(a). As a result, Lp(a) levels are genetically determined, reached by the age of two and remain constant throughout the life of the individual. Diet and lifestyle changes have little impact on Lp(a) levels and currently therapies are not able to adequately reduce elevated levels of Lp(a) to acceptable levels in patients who have severely elevated Lp(a). As a general guideline for ideal Lp(a) levels, the European Atherosclerosis Society recommends that Lp(a) levels be less than or equal to 50 mg/dL. ISIS-APOARx is designed to selectively reduce levels of Lp(a) by inhibiting the production of apolipoprotein(a).
ABOUT ISIS PHARMACEUTICALS, INC.
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 28 drugs to treat a wide variety of diseases with an emphasis on cardiovascular, metabolic, severe and rare diseases, and cancer. Isis’ partner, Genzyme, is commercializing Isis’ lead product, KYNAMRO™, in the United States for the treatment of patients with HoFH. Genzyme is also pursuing marketing approval of KYNAMRO in other markets. Isis’ patents provide strong and extensive protection for its drugs and technology. Additional information about Isis is available at www.isispharm.com.
SOURCE: ISIS Pharmaceuticals
Post Views: 298
CARLSBAD, CA, USA I April 3, 2013 I Isis Pharmaceuticals, Inc. (ISIS) announced today that it has initiated a Phase 1 clinical study for ISIS-APOA, an antisense drug targeting apolipoprotein(a) for the treatment of atherosclerosis. Apolipoprotein(a) contributes to the formation of plaque in arteries through its attachment to an LDL-C particle in a complex termed lipoprotein(a), or Lp(a). High levels of Lp(a) are associated with an increased risk of atherosclerosis, coronary heart disease, heart attack and stroke. ISIS-APOARx is designed to reduce Lp(a) by inhibiting the production of apolipoprotein(a). Isis plans to develop ISIS-APOARx to treat patients with high Lp(a) levels who are at high risk of experiencing cardiovascular events.
“Lp(a) is an independent risk factor for coronary heart disease. Although Lp(a) can be measured during a routine lipid blood panel, the lack of drugs that effectively lower Lp(a) have made treating patients with high Lp(a) levels difficult. Because elevated Lp(a) is an inherited genetic condition, patients are unable to adequately control their Lp(a) levels through diet or lifestyle changes. By inhibiting the production of apolipoprotein(a), ISIS-APOARx is designed to reduce the levels of Lp(a), thereby offering a unique and specific approach to treating patients who have high cardiovascular risk due to high Lp(a) levels,” said Walter Singleton, M.D., vice president of development and chief medical officer at Isis. “ISIS-APOARx is part of Isis’ strategy to create a cardiovascular disease franchise comprised of drugs that target all the key components of cardiovascular disease, including various atherogenic lipids, inflammation and thrombosis.”
The Phase 1 study of ISIS-APOARx is a blinded, placebo-controlled, dose-escalation study in approximately 56 healthy volunteers. The study is designed to assess the safety, tolerability and pharmacokinetics of both single and multiple doses of ISIS-APOARx.
ABOUT Lp(a)
Lp(a) is considered an independent risk factor for cardiovascular disease due to its association with an increased risk of coronary heart disease and atherosclerotic plaque formation. Lp(a) is a lipoprotein particle that is assembled in the liver that consists of an LDL-C-like particle and apolipoprotein(a). Lp(a) levels in blood can vary greatly between individuals due primarily to genetic variations in the gene that encodes for apolipoprotein(a). As a result, Lp(a) levels are genetically determined, reached by the age of two and remain constant throughout the life of the individual. Diet and lifestyle changes have little impact on Lp(a) levels and currently therapies are not able to adequately reduce elevated levels of Lp(a) to acceptable levels in patients who have severely elevated Lp(a). As a general guideline for ideal Lp(a) levels, the European Atherosclerosis Society recommends that Lp(a) levels be less than or equal to 50 mg/dL. ISIS-APOARx is designed to selectively reduce levels of Lp(a) by inhibiting the production of apolipoprotein(a).
ABOUT ISIS PHARMACEUTICALS, INC.
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 28 drugs to treat a wide variety of diseases with an emphasis on cardiovascular, metabolic, severe and rare diseases, and cancer. Isis’ partner, Genzyme, is commercializing Isis’ lead product, KYNAMRO™, in the United States for the treatment of patients with HoFH. Genzyme is also pursuing marketing approval of KYNAMRO in other markets. Isis’ patents provide strong and extensive protection for its drugs and technology. Additional information about Isis is available at www.isispharm.com.
SOURCE: ISIS Pharmaceuticals
Post Views: 298
