News

Lipoxen to Develop Improved Delivery of Antiviral Drugs for the Treatment of Liver Disease caused by Hepatitis C

04 November 2008

Lipoxen joins with Nottingham University to deliver antiviral drugs direct to the liver by means of nanoparticles for the treatment of viral hepatitis

London, UK, 4 November 2008 - Lipoxen PLC (AIM:LPX), 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 antihepatitis
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."