We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies. Cookie Policy.
Features Partner Sites Information LinkXpress
Sign In
Advertise with Us
RANDOX LABORATORIES

LDL-Lowering Monoclonal Antibody Shines in Early Clinical Trials

By BiotechDaily International staff writers
Posted on 17 Apr 2012
Print article
Results obtained in three phase 1 trials showed that a monoclonal antibody to the protein proprotein convertase subtilisin/kexin 9 (PCSK9) significantly reduced LDL (low-density lipoprotein) cholesterol levels in healthy volunteers and in subjects with familial or nonfamilial hypercholesterolemia.

PCSK9 is a serine protease, which binds to LDL receptors (LDLR), leading to their accelerated degradation, and to increased LDL cholesterol levels. The pharmaceutical company Regeneron (Tarrytown, NY, USA) is among several that have developed monoclonal antibodies specific for PCSK9 for clinical applications.

A paper published in the March 22, 2012, issue of the New England Journal of Medicine (NEJM) presented results of three clinical trials that were conducted to test the safety and effectiveness of REGN727 in human subjects.

The first set of trials comprised two randomized, single ascending-dose studies of REGN727 administered either intravenously (40 subjects) or subcutaneously (32 subjects), as compared with placebo. These studies were followed by a randomized, placebo-controlled, multiple-dose trial in adults with heterozygous familial hypercholesterolemia who were receiving atorvastatin (21 subjects) and those with nonfamilial hypercholesterolemia who were receiving treatment with atorvastatin (30 subjects). REGN727 doses of 50, 100, or 150 mg were administered subcutaneously on days 1, 29, and 43.

Results revealed that the drug was safe, since that among subjects receiving REGN727, there were no discontinuations because of adverse events. REGN727 significantly lowered LDL cholesterol levels in all the studies with up to a reduction of 60-65% in LDL cholesterol levels.

Regeneron employed their proprietary VelocImmune technology to derive a fully human monoclonal therapeutic antibody, which has shown excellent potential at this early stage of clinical trials.

Related Links:

Regeneron




Print article

Channels

Business

view channel

Collaborative Agreement to Aid in Setting Guidelines for Evaluating Potential Ebola Therapy

Cooperation between an Israeli biopharmaceutical company and medical branches of the US government is designed to set ground rules for continued evaluation of an experimental therapy for Ebola virus disease. RedHill Biopharma Ltd. (Tel Aviv, Israel), a biopharmaceutical company primarily focused on development and c... Read more
Copyright © 2000-2018 Globetech Media. All rights reserved.