THOUSAND OAKS, Calif., Nov. 12, 2013 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced that it will present new data on evolocumab (AMG 145), an investigational fully human monoclonal antibody that inhibits PCSK9, a protein that reduces the liver's ability to remove low-density lipoprotein cholesterol (LDL-C), or "bad" cholesterol, from the blood 1, at the upcoming American Heart Association (AHA) Scientific Sessions 2013, being held Nov. 16 – 20 in Dallas.
Data from the Phase 2 OSLER ( Open Label Study of Long T ERm Evaluation Against LDL-C Trial) study, which evaluates the safety, tolerability and sustained efficacy of long-term administration of evolocumab and standard of care in more than 1,100 patients with high cholesterol, will be featured during a Clinical Science: Special Reports session on Tuesday, Nov. 19, at 4:51 p.m. CST.
"The Phase 2 OSLER study provides the first long-term 52-week data for a PCSK9 inhibitor in diverse patient populations with high cholesterol," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "We hope the data we are accumulating from our Phase 3 clinical program for evolocumab will help advance care for patients who struggle to control high cholesterol and have an urgent unmet need."
Additionally, Amgen will highlight findings from long-term open-label data accumulated from patients in GAUSS ( Goal Achievement after Utilizing an anti-PCSK9 antibody in Statin intolerant Subjects) and MENDEL ( Monoclonal Antibody Against PCSK9 to Reduce Elevated LDL-C in Patients Currently Not Receiving Drug Therapy For Easing Lipid Levels), two Phase 2 studies that evaluated evolocumab in patients with hyperlipidemia who cannot tolerate statins and as a stand-alone treatment, respectively.Data presented on evolocumab will include:
- Randomized Comparison of the Safety, Tolerability, and Efficacy of Long-Term Administration of AMG 145 Versus Standard of Care in 1104 Patients: 52-Week Results from the OSLER Study CS.03, Clinical Science: Special Reports, Tuesday, Nov. 19, 4:51 - 5:01 p.m. CST (Ballrooms C1 & C2)
- Efficacy and Safety of Long-Term Treatment with AMG 145 Monotherapy Abstract 12191, Abstract Poster Session, Tuesday, Nov. 19, 3 - 4:30 p.m. CST (Hall F, Core 2, Poster Board: 2010)
- Efficacy and Tolerability of Long-Term Treatment With AMG 145 in Patients With Statin IntoleranceAbstract 12621, Abstract Poster Session, Tuesday, Nov. 19, 3 - 4:30 p.m. CST (Hall F, Core 2, Poster Board: 2009)