Lipoxen in antiviral drug delivery development

A UK biopharma company specialising in the development of high value differentiated biologicals, vaccines and oncology drugs has teamed up with the University of Nottingham to develop enhanced formulations of antiviral drugs for the treatment of liver diseases.

Lipoxen and Nottingham University's 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.

They will use novel proprietary formulations based on liposome and nanoparticle delivery to achieve enhanced therapeutic effects by delivering the drugs directly to the liver. This approach is 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.

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 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.

The project is receiving funding from the East Midlands' bioKneX Industrial Partnership Scheme.

Lipoxen ceo M. Scott Maguire, 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 initial 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."