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
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
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
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.