Phosphagenics Limited has completed an animal trial demonstrating that it's new patented drug, APA-01, can greatly slow or prevent the development of atherosclerosis, the leading cause of heart disease in the western world.
Atherosclerosis is a common and progressive disease of the arteries, especially the aorta, that leads to the formation of plaque and consequently to diseases such as angina, heart attack (myocardial infarction), stroke and dementia.
The findings in the animal study are a significant milestone in the development of the drug APA-01 as a treatment for heart disease. It is the first indication that the extremely positive results previously obtained by Phosphagenics in extensive in vitro trials can be duplicated in an animal model, the release said.
The multi-national animal trial comprises three arms.
The first arm of the multi-national study examined the ability of APA-01 to prevent the development of atherosclerosis in rabbits. Rabbits were divided into two groups and fed a very high cholesterol diet for four weeks.
Rabbits administered the Phosphagenics drug had about 60% fewer plaque lesions in their arteries compared to the rabbits that were not given the drug. Additionally the rabbits that were given APA-01 had a 30 % reduction in the expression of CD 36 receptors. These receptors are responsible for lipid uptake and deposition of cholesterol in arteries.
Dr Esra Ogru, VP, Research & Development, said, "The reduction in the expression of the CD 36 receptor is an important finding as it indicates that the drug may have application for many diseases that are caused by inflammation."
Dr Ogru added, "Good results achieved in in vitro studies, do not necessarily translate into similar results in animals. The fact that the results obtained in a well established animal model commonly used in atherosclerosis studies were so impressive bodes well for human studies that are aimed to commence later this year".
The second arm of the study is well underway. The third arm has also commenced.
In the US alone, an estimated 14 million people are diagnosed with heart disease, the majority of which suffer from atherosclerosis. Around a million of those die from heart attacks each year with annual costs associated with that disease estimated to be around US $100 billion.
In Australia, estimated costs of heart disease amount to $4 billion. There are no commercially available drugs that treat atherosclerosis directly, with most drugs designed to treat the risk factors associated with heart disease, such as lowering cholesterol or blood pressure, rather than the disease itself. APA-01, a unique anti-inflammatory agent, will treat atherosclerosis directly.