News

Lipoxen Announces Positive Data for its ImuXen ® Liposomal Technology

12 June 2006

New Hepatitis-E Vaccine Candidate Poised to Enter Clinical Development
 
London, UK, 12 June, 2006 – Lipoxen PLC (AIM: LPX) a biopharmaceutical company specialising in the development of high value differentiated biologicals, vaccines and oncology drugs, today announced positive results in a highly relevant pre-clinical model with its novel vaccine delivery technology, ImuXen®. This technology uses a proprietary liposomal formulation method to deliver vaccine materials to the immune system, in a manner which is designed to emulate the response of a natural encounter with the infectious agent. The key benefit of Lipoxen’s ImuXen® technology is that it gives rise to strong immunological responses, akin to that achieved by live attenuated vaccines, while avoiding completely the risk of infection as a result of vaccination which is a rare but significant consequence of some live attenuated vaccines.
 
The positive data, which has been announced today, is from a pre-clinical study of Lipoxen’s vaccine candidate for the prevention of hepatitis-E. The collaborative study to determine the vaccine’s safety and efficacy was conducted using Lipoxen’s proprietary ImuXen® formulation technology, coupled with manufacturing expertise of the Serum Institute of India Ltd. and the virology expertise of the National Institute of Virology, Pune, India. The new liposomal vaccine gave rise to a very strong antibody response against the vaccine immunogen. After vaccination, there was complete protection from liver disease, as demonstrated by measurement of liver enzymes, and the lack of virus shedding as a result of infection, measured by the sensitive technique of ‘nested PCR’, following exposure to the live virus. These results provide a high degree of confidence that the vaccine will be effective in man and clinical trials are planned for the first half of 2007.
 
Hepatitis-E is the most common form of acute hepatitis in developing countries. It is a debilitating disease picked up from contaminated water affecting travellers and people who live in parts of the world where rain or floodwater is liable to contaminate the water supply with human faecal matter. It is particularly liable to cause outbreaks of hepatitis in military personnel who have had no previous exposure to the virus. Hepatitis-E, although less serious than the chronic ‘B’ and ‘C’ forms of hepatitis, is potentially fatal, and is particularly dangerous in pregnant women. Currently there is no vaccine for hepatitis-E.
 
Sir Brian Richards, Chairman of Lipoxen, commented:
 
“We are very pleased with the pre-clinical results that we have announced today for our vaccine delivery technology ImuXen®. The fact that it has allowed us to develop a new hepatitis-E vaccine demonstrates our capability to create novel vaccine solutions in an area of unmet medical need. We look forward to moving this new vaccine candidate into the clinical phase and also to developing a series of new vaccines in collaboration with our partner the Serum Institute of India, based on our proprietary ImuXen® technology.
 
“In addition, we believe ImuXen® can be applied to improve upon some of the largest selling vaccines currently on the market, including Wyeth’s pneumococcal vaccine Prevnar®, which has a market in excess of $1 billion.”
 
 
Enquiries
 
Lipoxen PLC  
Peter Laing, Director of Business Development +44 (0)7990 523798
   
Citigate Dewe Rogerson +44 (0)20 7638 9571
David Dible/Yvonne Alexander   
 
 
Notes to Editor
 
Lipoxen PLC (LSE?) is a biopharmaceutical company specialising in the development of high value differentiated biologicals, vaccines and oncology drugs. Potential products, which address markets in excess of US$1 billion, currently under development include improved formulations of important biologicals including EPO, G-CSF, insulin and Interferon-alpha based on Lipoxen’s proprietary PolyXen® technology. This 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 Hepatitis B 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 already co-developing products with Serum Institute of India, one of the world’s leading vaccine companies. In addition, its technologies are being currently evaluated by leading biotechnology companies such as Baxter, Amgen, Genzyme and Genentech.
 
Lipoxen was admitted to trading on the AIM Market of the London Stock Exchange in January 2006.
 
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.