Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

Antibody injection lowers LDL, adding to effectiveness of statin therapy

27.03.2012
New research shows SAR236553/REGN727 reduces LDL by up to 72 percent in patients

A novel monoclonal antibody identified in a new study dramatically lowered circulating LDL cholesterol by 40 percent to 72 percent, a development with potential to provide a new option for patients who are resistant to cholesterol-lowering drugs such as statins or to the current standard of care, according to research presented today at the American College of Cardiology's 61st Annual Scientific Session.

The Scientific Session, the premier cardiovascular medical meeting, brings cardiovascular professionals together to further advances in the field.

The traditional statin therapy used by millions of Americans lowers LDL cholesterol – the "bad" cholesterol that leads to plaque build-up in the arteries and subsequently heart disease – by inhibiting the production of cholesterol in liver cells, causing an increase in the number of LDL receptors on the cell surface. These receptors grab LDL circulating in the blood and deliver it into the liver, where it is subsequently processed and flushed out of the body. About one in five people with high low-density lipoprotein (LDL) are resistant to cholesterol-lowering drugs such as statins, and for many others the current standard of care does not lower cholesterol enough.

A recent discovery showed that statin therapy stimulates the production of PCSK9, an enzyme that leads to the destruction of LDL receptors. The present study tested SAR236553/REGN727, a monoclonal antibody that binds to PCSK9, blocking its effects and preventing the degradation of LDL receptors. More LDL receptors mean more LDL is brought out of the blood into the liver, and circulating levels of LDL cholesterol decrease.

"We've known for 30 years that lowering LDL cholesterol with statins lowers the risk of heart disease and that the more you can lower LDL cholesterol, the greater reduction in that risk," said James McKenney, PharmD, chief executive officer of National Clinical Research, and the study's lead investigator. "However, we know in some cases that even the best statin can't get LDL cholesterol as low as it should be."

This multi-center, randomized trial looked at 183 patients who had an LDL cholesterol reading of 100 mg/dL or higher. The patients had already been treated with atorvastatin for more than six weeks at stable doses of 10, 20 or 40 mg. The participants were divided into six groups: a placebo control; three groups who received a subcutaneous injection of SAR236553/REGN727 every two weeks (Q2W) at doses of either 50, 100, or 150 mg; and two groups who received an injection of SAR236553/REGN727 at 200 or 300 mg every 4 weeks (Q4W), alternating with placebo shots at two weeks. The study's primary endpoint was the percentage LDL cholesterol reduction from baseline to after 12 weeks.

Dr. McKenney reported a remarkable dose-response to SAR236553/REGN727 injections. Circulating LDL cholesterol was lowered by 40 percent, 64 percent, and 72 percent in patients assigned to 50, 100, or 150 mg Q2W doses, respectively. LDL cholesterol was reduced by 43 percent and 48 percent for patients who received 200 or 300 mg Q4W injections. The placebo group reported a 5 percent reduction of circulating LDL cholesterol.

"Our LDL cholesterol treatment goals were less than 100 or 70 mg/dL," Dr. McKenney said. "All of the participants receiving one of our doses met those goals."

Dr. McKenney said the results surprised him, "Statins are good medicines and getting a 70 percent reduction on top of them is remarkable."

The SAR236553/REGN727 antibody was discovered two years ago, and these are the first Phase II results for an anti-PCSK9 antibody to be presented. Dr. McKenney said a longer study is needed to establish the long-term safety of the antibody, but the results from this trial were promising, with only one adverse reaction reported.

"This is a very hopeful step in the treatment of heart disease in this country," said Dr. McKenney.

This study was funded by Sanofi US, Bridgewater, N.J., and Regeneron Pharmaceuticals, Tarrytown, N.Y. Dr. McKenney reports that he is an employee of a research company that has received research funding from Regeneron and Sanofi.

The study will be simultaneously published in the Journal of the American College of Cardiology and will be published online at the time of presentation.

Dr. McKenney will be available to the media on Monday, March 26 at 12:15 p.m. in Media Room 1, McCormick Place N, Level 1, Hall C1.

Dr. McKenney will present the study "A Randomized, Double-blind, Placebo-controlled Trial of the Safety and Efficacy of a Monoclonal Antibody to Proprotein Convertase Subtilisin/Kexin Type 9 Serine Protease, REGN727/SAR236553, in Patients with Primary Hypercholesterolemia" on Monday, March 26 at 10:30 a.m. in McCormick Place North: Main Tent.

About the American College of Cardiology

The American College of Cardiology (www.cardiosource.org) is a 40,000-member nonprofit medical society comprised of physicians, surgeons, nurses, physician assistants, pharmacists and practice managers. The College transforms cardiovascular care and improves heart health as it supports and advocates for quality improvement, patient-centered care, payment innovation and professionalism. The ACC bestows credentials upon cardiovascular specialists who meet its stringent qualifications and leads the formulation of health policy, standards and guidelines. It provides professional education, supports and disseminates cardiovascular research, and operates national registries to measure and promote quality.

The ACC's Annual Scientific Session brings together cardiologists and cardiovascular specialists from around the world each year to share the newest discoveries in treatment and prevention.

Beth Casteel | EurekAlert!
Further information:
http://www.acc.org

Further reports about: Cardiology LDL Sanofi heart disease monoclonal antibody statin therapy

More articles from Health and Medicine:

nachricht Study suggests possible new target for treating and preventing Alzheimer's
02.12.2016 | Oregon Health & Science University

nachricht The first analysis of Ewing's sarcoma methyloma opens doors to new treatments
01.12.2016 | IDIBELL-Bellvitge Biomedical Research Institute

All articles from Health and Medicine >>>

The most recent press releases about innovation >>>

Die letzten 5 Focus-News des innovations-reports im Überblick:

Im Focus: Shape matters when light meets atom

Mapping the interaction of a single atom with a single photon may inform design of quantum devices

Have you ever wondered how you see the world? Vision is about photons of light, which are packets of energy, interacting with the atoms or molecules in what...

Im Focus: Novel silicon etching technique crafts 3-D gradient refractive index micro-optics

A multi-institutional research collaboration has created a novel approach for fabricating three-dimensional micro-optics through the shape-defined formation of porous silicon (PSi), with broad impacts in integrated optoelectronics, imaging, and photovoltaics.

Working with colleagues at Stanford and The Dow Chemical Company, researchers at the University of Illinois at Urbana-Champaign fabricated 3-D birefringent...

Im Focus: Quantum Particles Form Droplets

In experiments with magnetic atoms conducted at extremely low temperatures, scientists have demonstrated a unique phase of matter: The atoms form a new type of quantum liquid or quantum droplet state. These so called quantum droplets may preserve their form in absence of external confinement because of quantum effects. The joint team of experimental physicists from Innsbruck and theoretical physicists from Hannover report on their findings in the journal Physical Review X.

“Our Quantum droplets are in the gas phase but they still drop like a rock,” explains experimental physicist Francesca Ferlaino when talking about the...

Im Focus: MADMAX: Max Planck Institute for Physics takes up axion research

The Max Planck Institute for Physics (MPP) is opening up a new research field. A workshop from November 21 - 22, 2016 will mark the start of activities for an innovative axion experiment. Axions are still only purely hypothetical particles. Their detection could solve two fundamental problems in particle physics: What dark matter consists of and why it has not yet been possible to directly observe a CP violation for the strong interaction.

The “MADMAX” project is the MPP’s commitment to axion research. Axions are so far only a theoretical prediction and are difficult to detect: on the one hand,...

Im Focus: Molecules change shape when wet

Broadband rotational spectroscopy unravels structural reshaping of isolated molecules in the gas phase to accommodate water

In two recent publications in the Journal of Chemical Physics and in the Journal of Physical Chemistry Letters, researchers around Melanie Schnell from the Max...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

Event News

ICTM Conference 2017: Production technology for turbomachine manufacturing of the future

16.11.2016 | Event News

Innovation Day Laser Technology – Laser Additive Manufacturing

01.11.2016 | Event News

#IC2S2: When Social Science meets Computer Science - GESIS will host the IC2S2 conference 2017

14.10.2016 | Event News

 
Latest News

NASA's AIM observes early noctilucent ice clouds over Antarctica

05.12.2016 | Earth Sciences

Shape matters when light meets atom

05.12.2016 | Physics and Astronomy

Researchers uncover protein-based “cancer signature”

05.12.2016 | Life Sciences

VideoLinks
B2B-VideoLinks
More VideoLinks >>>