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Monoclonal antibody injection lowers bad cholesterol in trial

Kathleen Blanchard's picture
An injection may someday help patients lower their bad cholesterol levels.

Researchers are investigating an injection of a monoclonal antibody for treating high levels of so called bad LDL cholesterol, which is known to up the chances of having a heart attack. The antibody acts by targeting a recently discovered cholesterol regulator in the body called PCSK9.

PCSK9 is a gene that instructs the body to make a protein that regulates the amount of cholesterol in the bloodstream by controlling the number of LDL receptors.

When the cholesterol controlling gene is overactive, the result is high cholesterol that can be resistant to cholesterol lowering medications.

The injection is a man-made protein and is called AMG145.

In findings presented at the American Heart Association's Scientific Sessions 2011, lead researcher Clapton Dias, Ph.D., said, "PCSK9 is the first target in lipid metabolism to be inhibited using a monoclonal antibody, and it appears to be a promising way to lower bad cholesterol." Dias is also who medical sciences director of clinical pharmacology and early development at Amgen, Inc., in Thousand Oaks, Ca.

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In a clinical trial that included 54 healthy men and two women, 18 to 45 years old, AMG145 lowered LDL cholesterol –specifically apo-B – without affecting ‘good’ HDL cholesterol or triglycerides.

"The more PCSK9 was lowered, the more bad cholesterol levels went down," Dias said. "With higher doses, bad cholesterol stayed lower for a longer period."

In the trial, none of the individuals were on medications.

The next step is to see how well the cholesterol lowering shot works in adults who take statin medication to control their cholesterol.

If the shot lowers cholesterol in a larger group of people, it would provide a new treatment for patients unable to control cholesterol levels with statins.

In the trial, none of the participants experienced side effects of the monoclonal antibody. The study found injecting AMG145 lowered the activity of PCSK9, which in turn lowered ‘bad’ LDL cholesterol levels. Based on the research, it may be someday possible to give a shot to patients to lower LDL cholesterol levels, which in turn can thwart heart disease.

Image credit: Morguefile