NEW YORK (GenomeWeb) – Interleukin Genetics today said that it will provide its genetic testing services to Isis Pharmaceuticals for a Phase II clinical study evaluating the novel therapeutic ISIS-APO(a)Rx in patients with high levels of lipoprotein(a), or Lp(a), an independent risk factor for cardiovascular disease.
Interleukin's genetic test panels for inflammatory and metabolic diseases will be used to investigate genetic factors that may add value to the clinical trial, Interleukin CEO Kenneth Kornman said in a statement, adding that in a recent study, the company, using its assays, was able to identify patients with elevated Lp(a) levels who also overproduced interleukin-1.
Patients with elevated levels of Lp(a) are at an increased risk for atherosclerosis, coronary heart disease, aortic stenosis, heart attack, and stroke. Isis is developing ISIS-APO(a)Rx to inhibit the production of the apolipoprotein(a) component of Lp(a) and to treat patients with high levels of the lipoprotein who are at risk for life-threatening cardiovascular events.
According to Isis, the Phase II study will evaluate the safety and efficacy of ISIS-APO(a)Rx. The 12-week study will evaluate 100 mg, 200 mg, and 300 mg doses of the drug in about 60 patients with Lp(a) levels of at least 50 mg/dL. An average level of 30mg/dL is considered normal, Interleukin said, citing the National Institutes of Health.