Atherosclerosis vaccine
The results of a preliminary clinical trial involving healthy volunteers showed that the new drug reduces the level of low-density lipoproteins ("bad" cholesterol) in the blood by an average of 64% more effectively than placebo.
The active ingredient of AMG145 is human monoclonal antibodies synthesized by specialists of the California company Amgen, binding to the cholesterol concentration regulator PCSK9 (proprotein convertase subtilisin/kexin type 9). This protein reduces the ability of liver cells to remove low-density lipoproteins from the bloodstream, so its inactivation leads to a significant improvement in the levels of bad cholesterol in the blood.
The study involved 54 men and 2 women aged 18 to 45 years. All participants were practically healthy, did not smoke and did not take any other medications at the time of the study. Each of them received a single injection containing one of five dosages of AMG145 or placebo. Sixteen participants were injected intravenously, the rest – subcutaneously.
After administration of the drug, the cholesterol content in the blood of the participants, as well as the levels of other laboratory markers of the state of the cardiovascular system, were regularly assessed for 85-113 days.
Analysis of laboratory data showed that an increase in the dosage of AMG145 was accompanied by a decrease in the level of the active form of PCSK9 protein; a decrease in the blood content of low–density lipoproteins, total cholesterol and apolipoprotein B (Apo B) - the main protein component of "bad" cholesterol.
At the same time, the change in the activity of the PCSK9 regulator did not affect the content of triglycerides, high-density lipoproteins ("good" cholesterol) and associated proteins in the blood. In other words, all blood lipid parameters remained at the same levels.
All study participants tolerated the drug administration well; the number of adverse reactions they had was comparable to the corresponding indicator obtained for the control group.
Currently, the company is already conducting a similar study, in which adult patients taking statin-class drugs to reduce cholesterol in the blood are repeatedly injected with different dosages of AMG145. If the results of this and subsequent clinical studies demonstrate the safety and effectiveness of the drug, it will become a solution to the problem for people who are not helped by existing methods of lowering cholesterol levels in the blood. In addition, the resulting decrease in the level of "bad" cholesterol in vaccinated (albeit healthy) subjects compared to the control group is about 2 times higher than the same indicator obtained when comparing the effect of taking statins and placebo in patients with elevated cholesterol levels.
Evgeniya Ryabtseva
Portal "Eternal youth" http://vechnayamolodost.ru based on the materials of the American Heart Association:
Injection lowers cholesterol in preliminary human trial.
16.11.2011