Using Nanoparticles to Treat Viral Hepatitis

Lipoxen PLC, a bio-pharmaceutical company specialising in the development of high value differentiated biologicals, vaccines and oncology drugs, announces today that it has entered into a research agreement with the University of Nottingham to develop new enhanced fomulations of antiviral drugs for the treatment of important liver diseases such as viral hepatitis which is caused by hepatitis C (HCV). The two parties will use novel proprietary formulations based on liposome and nanoparticle delivery in order to achieve enhanced therapeutic effects by delivering the drugs directly to the liver. This approach is also expected to reduce the toxicity of anitviral drugs used to treat liver disease by limiting their uptake by other tissues and by red blood cells (erythrocytes). This project is receiving funding from the East Midlands' bioKneX Industrial Partnership Scheme. Other financial details were not disclosed.

Hepatitis, due to hepatitis C virus infection, is a growing problem already affecting 150-200 million people worldwide. In recent years the pharmaceutical industry has invested considerable sums in attempts to develop new drugs for hepatitis C, but unfortunately nearly all of these drugs have failed in clinical development, or have met with only limited commercial success, mainly due to systemic toxicity.

Lipoxen and Nottingham University's present project is designed to address the systemic toxicity of anti-hepatitis C drugs, which limits the dose at which they can be administered and thereby compromises their efficacy, by engineering their selective delivery to the liver using nanoparticles. By improving delivery of the drug to the affected organ, the project seeks to greatly improve the efficacy of anti-hepatitis C drugs by allowing them to be given at higher (i.e. more effective) doses by limiting their systemic toxicity.

The two parties will initially work on developing a new proprietary "super generic" formulation of ribavirin, the most commonly used antiviral drug to treat viral hepatitis. This commercially attractive product, which will be based on liposome or nanoparticle delivery, will be able to be used in combination with PEG-IFN (pegylated - interferon). Ribavirin, in combination with PEG-IFN, is the most commonly used treatment regime for viral hepatitis globally.

Once this has been achieved the two parties intend to look at improving the delivery of other antiviral drugs for the treatment of hepatitis C that have failed to reach the market due to problems which could potentially be resolved by this novel formulation technology. Failed anti-hepatitis C drugs include development candidates from, amongst others, GlaxoSmithKline Boehringer Ingelheim and Wyeth.

M. Scott Maguire, CEO of Lipoxen, said: "We are very excited to be working with the University of Nottingham on this project as we believe that by combining our expertise in liposomal and nanoparticle drug formulation with their tissue engineering and molecular virology expertise, we can develop a new "direct to liver" delivery solution to improve the effectiveness of hepatitis C drugs. Our intial target will be to demonstrate the value of this new delivery approach using ribavirin the most widely used drug globally to treat viral hepatitis."

"Once we have developed this new formulation we believe we can significantly extend its commercial potential in the field drug delivery to the liver by taking advantage of the opportunity to resurrect several 'near-miss' new drug candidates from major pharma companies that were being developed for the treatment of HCV infection."

Will Irving, Professor of Virology at the University of Nottingham, said: "We are delighted to be involved in this exciting project. If we can succeed in delivering increased doses of ribavirin to the infected liver through our novel delivery systems, it is highly likely we will improve treatment response rates, which are currently limited mostly by the amount of ribavirin an individual patient can tolerate. In addition, such a 'proof of principle' would open up other opportunities for the use of powerful antiviral drugs that are also limited by their systemic toxicities.

"We have a long-term research programme into many aspects of hepatitis C virus infection in the University of Nottingham, and have developed systems in the laboratory for testing drug activity which will underpin our experiments in this project. Lipoxen have an established track record of production of liposomal formulations, so this is an ideal partnership. In addition, we are planning to test and compare polymer nanoparticle delivery vehicles with liposomes, taking advantage of the considerable expertise in nanoparticle technology that exists within the University of Nottingham."

Hepatitis C Hepatitis-C is particularly serious in HIV-infected patients who are now surviving longer due to the effectiveness of combination drug therapies against HIV. Existing treatments for hepatitis C virus are only partially effective. Even patients who do not have a HIV co-infection and who receive "best standard of care" generally have only a 50-80% chance of being cured by drug treatments. Patients who do not achieve cure are liable to develop fibrosis, cirrhosis, cancer and failure of the liver, and may require liver transplantation.

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