Nanotechnology Now - Press Release: Lipoxen to Develop Improved Delivery of Antiviral Drugs for the Treatment of Liver Disease caused by Hepatitis C

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

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

London, UK | Posted on November 4th, 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 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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About Lipoxen PLC
Lipoxen Lipoxen PLC (AIM:LPX) is a biopharmaceutical company specializing in the development of high value differentiated biologicals, vaccines and oncology drugs. Products currently under development include improved formulations of important biologicals such as erythropoietin (EPO), G-CSF, insulin and Interferon-alpha. Lipoxen has two products in clinical development SuliXen, a long acting insulin and long-acting EPO. These novel products, which are based on Lipoxen's proprietary PolyXen® technology, each address markets in excess of US$1 billion.

Lipoxen's technology is designed to improve the stability, biological half-life and immunologic characteristics of therapeutic proteins naturally. Lipoxen has two further naturally-derived proprietary delivery technologies, ImuXen® and a related liposomal technology for the formulation of cytotoxic oncology drugs, which are being developed to enhance the efficacy and safety of various vaccines such as a multivalent Hepatitis B-E and pneumococcal vaccines, as well as a number of anti-cancer agents like paclitaxel. The Company's proprietary delivery technologies are attracting significant interest and Lipoxen is currently co-developing products with the Serum Institute of India Limited (one of the world's leading vaccine companies, India's largest biotech company and a major shareholder in Lipoxen) and has license agreements in place with Baxter International and InterVet, a leading animal health company.

Lipoxen was admitted to trading on the AIM Market of the London Stock Exchange in January 2006.

The University of Nottingham is ranked in the UK's Top 10 and the World's Top 100 universities by the Shanghai Jiao Tong (SJTU) and Times Higher (THE) World University Rankings.

It provides innovative and top quality teaching, undertakes world-changing research, and attracts talented staff and students from 150 nations. Described by The Times as Britain's "only truly global university", it has invested continuously in award-winning campuses in the United Kingdom, China and Malaysia. Twice since 2003 its research and teaching academics have won Nobel Prizes. The University has won the Queen's Award for Enterprise in both 2006 (International Trade) and 2007 (Innovation - School of Pharmacy), and was named 'Entrepreneurial University of the Year' at the 2008 Times Higher Education Awards.

Its students are much in demand from 'blue-chip' employers. Winners of Students in Free Enterprise for four years in succession, and current holder of UK Graduate of the Year, they are accomplished artists, scientists, engineers, entrepreneurs, innovators and fundraisers. Nottingham graduates consistently excel in business, the media, the arts and sport. Undergraduate and postgraduate degree completion rates are amongst the highest in the United Kingdom.

This announcement includes 'forward-looking statements' which include all statements other than statements of historical facts, including, without limitation, those regarding the Company's financial position, business strategy, plans and objectives of management for future operations (including development plans and objectives relating to the Company's products and services), and any statements preceded by, followed by or that include forward-looking terminology such as the words 'targets', 'believes', 'estimates', 'expects', 'aims', 'intends', 'will', 'can', 'may', 'anticipates', 'would', 'should', 'could' or similar expressions or the negative thereof. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors beyond the Company's control that could cause the actual results, performance or achievements of the Company to be materially different from future results, performance or achievements expressed or implied by such forward-looking statements. Such forward-looking statements are based on numerous assumptions regarding the Company's present and future business strategies and the environment in which the Company will operate in the future. Among the important factors that could cause the Company's actual results, performance or achievements to differ materially from those in forward-looking statements include those relating to The Company's funding requirements, regulatory approvals, clinical trials, reliance on third parties, intellectual property, key personnel and other factors. These forward-looking statements speak only as at the date of this announcement. The Company expressly disclaims any obligation or undertaking to disseminate any updates or revisions to any forward-looking statements contained in this announcement to reflect any change in the Company's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based. As a result of these factors, readers are cautioned not to rely on any forward-looking statement.

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Contacts:
M. Scott Maguire
Chief Executive Officer
+44 (0)20 7691 3583

Teathers (nominated adviser)
Shaun Dobson / Claes Spång
+44 (0)20 7426 9000

Citigate Dewe Rogerson
+44 (0)20 7638 9571
David Dible / Heather Keohane

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