Reduction of effective dose of statins, by liver targeting delivery, could be a way to bring the drugs to the prevention market - proof-of-concept trial by Lycotec Ltd.

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reducing the effective dose of statins minimises their potential side-effects and expands their use not only for the treatment but also for the prevention of CHD

Reducing the effective dose of statins minimises their potential side-effects and expands their use not only for the treatment but also for the prevention of CHD, the dominating killer disease in the developed world.

Statins are one of the most successful drugs able to slow down the formation of cholesterol-rich atherosclerotic plaques on the arterial walls, and reduce the development of and mortality from coronary heart disease, CHD.

Although their efficacy in management of elevated LDL cholesterol and CHD is not questionable, recommendation of their use for preventative purposes for healthy people or even borderline conditions is a subject of an ongoing strong debate.

Statins like many other drugs have their own side-effects. The use of them for people with elevated cholesterol or with already established CHD overpowers these side-effects. However, the use of statins for preventative purposes with possibilities to develop, albeit not too frequent, but still negative reactions, remains controversial.

The main reason behind the side-effects is the distribution and accumulation of statins outside their main target, the liver, into skeletal muscles or other organs.

Lycotec Ltd., the Cambridge UK based biotech company has developed and patented liver targeting oral delivery technology, LycosomeTM -

Based on this technology, the company has created a prototype, LycoStatinTM.

In a double blind study 40 volunteers with elevated LDL cholesterol were randomised and distributed in 5 groups with 8 participants each. The first three groups received daily either 20, or 40 or 80 mg of Simvastatin. The fourth group received LycoStatinTM containing 20 mg of Simvastatin. and the fifth group received a control lycopene, the carotenoid with is used to make Lycosomes, in the same dose as in the fourth group.

After one month of the trial it was shown that the level of the reduction of LDL cholesterol in the fourth group was significantly stronger than in the groups taking 20 or 40 mg of Simvastatin, and was at the same level as in the group which was taking 80 mg of the drug. There were no changes in LDL level in the fifth group.

These preliminary results indicate that the liver targeting delivery could increase the efficacy of statins, by apparent reduction of their random distribution to other organs, which are not involved in LDL synthesis, hence potentially minimise the side-effects of these drugs.

Some results of this trial have now been published in a peer review journal as a State of the Art Paper:

Later this week the Lycotec team, Dr Ivan Petyaev and Dr Yuiry Bashmakov, will present the LycoStatinTM at the World Liver Targeting Conference in Malta:

The company believes that reducing the effective dose of statins, minimising their potential side-effects, would allow these drugs, which have already saved millions of lives of people with CHD, to expand their benefit to even more millions of healthy people to prevent the development of this dominating killer disease in the developed world.

Lycotec is now looking for pharmaceutical industry partnership to further develop LycoStatin and bring it, and its potential range, to the CHD preventative market.

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Ivan Petyaev
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