Project Lead(s): Aldar Bourinbayar
Cardiovascular diseases (CVD) are the leading cause of death in the world, being responsible for a third of all fatalities.
Coronary heart disease (CHD) accounts for the greatest proportion of CVDs, with atherosclerosis and obesity both being risk factors.
Conventional methods for controlling abnormal lipid metabolism involve controlling dietary intake of fats or treatment with cholesterol-reducing drugs, such as statins.
However, dietary change is often ineffective and drugs have been associated with unwanted side effects, meaning alternative means to prevent and/or treat atherosclerotic and metabolic disease are needed.
The goal of this project was to conduct an efficacy study of V6, a proprietary oral formulation developed by Immunitor and derived from porcine adipose tissue for atherosclerosis immunotherapy.
Some studies suggest that atherosclerosis and obesity are caused by a self-directed immune reaction against adipose tissue. If this is the case, then oral administration of auto antigens may produce the desired immune tolerance, which could counteract the inflammatory process.
Earlier work of the team has shown that oral administration of pooled antigens from adipose tissue (V6) is safe and can favourably affect the abnormal lipid metabolism in humans.
This study aimed to further validate initial findings through a 240-patient, placebo-controlled, randomized, double-blinded, clinical trial in overweight males and females in Mongolia and Ukraine. The only inclusion criteria for study entry were baseline waist circumference corresponding to ≤100 cm for males and ≤80 cm for females – the cut-off numbers for obese individuals.
Patients were enrolled and randomized into V6 (N=121) and placebo (N=119) arms and received one tablet of V6 or placebo daily for 30 days.
Results produced in the V6 trials support the immune nature of seemingly unrelated metabolic diseases, such as obesity, atherosclerosis, diabetes and even hypertension.
The magnitude of clinical response to V6 in this and other trials was comparable to the results obtained in clinical trials of cholesterol and obesity drugs, but without adverse side-effects.
Practically every endpoint evaluated showed V6 had a statistically significant advantage over placebo. However, the effect of V6 was less prominent than in prior Thai studies, which were two or three months long and had a higher dosing regimen of two pills/twice daily.
In the current study, after one month, levels of high-density lipoprotein (HDL) – the ‘good cholesterol’ – increased by 9.3%, compared to a 5.2% increase in the placebo arm.
In cholesterol-reducing drug trials it has been established that, for every 1% increase in HDL, there was a 3% reduction in death or myocardial infarction. Using this calculation, it could be hypothesized that V6 could reduce the risk of heart attack or death by 27.9%.
This is the first observation whereby all major cardiovascular risk factors were affected by a single immune intervention.
Researchers are currently negotiating with several potential partners to license-out, sell and/or expand V6 in additional countries, especially in China and Russia.
As a patent application is being prepared, no public disclosure is available at this time.