- LONDON (Dow Jones)--Phosphagenics
Limited said Friday that its new patented drug, APA-01, can greatly slow
or prevent the development of atherosclerosis, the successful completion
of an animal trial shows.
Atherosclerosis is the leading cause of heart disease in the western world,
the company said.
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,
said Phosphagenics.
It said 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 study forms the first arm of multi-national research collaboration
currently under way in Switzerland, USA, and Australia.
The multi-national animal trial comprises three arms.
The first arm, now completed, was designed to determine whether APA-01
could prevent the development of atherosclerosis.
The second will investigate whether the drug can reduce and treat existing
atherosclerotic plaques, initially in animals and then in humans.
The third arm of the animal study will focus on the ability of APA-01 to
improve the absorption and efficacy of statins.
Statins, which reduce cholesterol and thereby the risk of cardiac disease,
are the world's largest selling drugs with sales exceeding $26bn annually.
However, most statins are poorly absorbed by the body.
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.
One of the groups was administered APA-01 on a daily basis from the commencement
of the study while the second group did not receive the drug.
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, Vice President 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.
"We do not expect the various arms of the study to be completed before
the end of the third quarter of 2005. With the good results that we have
obtained, the trial has been extended several times to look at different
variables." said Dr Ogru.
The third arm of the study potentially has great commercial significance
for Phosphagenics. Several of the largest selling statins will shortly
be coming off patent. As such many of the drug companies are seeking extensions
of their patents and perceive that this may be achieved by combining them
with other drugs.
The combination of statins with APA-01 falls into this category. "Based
on the correlation between the laboratory results and the animal trial,
we are very optimistic about the third arm of our study", said Dr
Ogru.
"APA-01, when mixed with a well known statin produced laboratory in
vitro results that indicate a substantial enhancement of the effectiveness
of the statin."
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.
-
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