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Lipoxen PLC (XEN)

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Monday 16 June, 2008

Lipoxen PLC

Phase I Trial

RNS Number : 7369W
Lipoxen PLC
16 June 2008

Lipoxen PLC

('Lipoxen' or 'the Company')

Lipoxen has received approval to conduct the second Phase I trial 

of its long-acting erythropoietin (EPO), ErepoXen®, in Canada 


Novel product candidate for the treatment of anaemia in patients receiving renal dialysis is based on PolyXen® technology delivery technology 

London, UK, 16 June 2008 - Lipoxen PLC (AIM:LPX), a bio-pharmaceutical company specialising in the development of high value differentiated biologicals, vaccines and oncology drugs, announces today it has received approval along with its co-development partner company Serum Institute of India Ltd., to conduct a Phase I trial of ErepoXen®, its long-acting erythropoietin (EPO), in Canada. This trial, which is expected to start in July, is the second Phase I trial for this product. The first Phase I trial was conducted in India, and results showed the product to be well tolerated with the potential to be dosed once monthly thereby providing an improved dosing regime for patients. The global EPO market is currently worth $9 billion and existing EPO therapies are generally administered between once and three times a week.


The Phase I study, which is taking place at Anapharm's, the contract research organisation, clinical research facilities in Canada, is a randomised double-blind, placebo-controlled trial. The study is designed to assess the safety and tolerability of ErepoXen, formulated using Lipoxen's proprietary PolyXen® technology, at single doses of 1.0ug/kg, 2.0ug/kg, 4.0ug/kg or 6.0ug/kg. The trial will involve 32 healthy adult males, 24 of whom will receive the product candidate while eight will receive placebo, via subcutaneous injection. It is anticipated the results of this Phase I clinical trial will be available in Q4 08.


ErepoXen is formulated using Lipoxen's proprietary PolyXen technology. This technology is based on polysialic acid (PSA), a naturally occurring polymer which is biodegradable, non-immunogenic and non-toxic. Current EPO therapies are generally administered between once and three times a week and this trial aims to demonstrate the benefits of ErepoXen's sustained-release characteristics as compared to current EPO drug products. 


M. Scott Maguire, CEO of Lipoxen, said:

'We are extremely pleased that Lipoxen has received approval by the Canadian authorities to conduct this second Phase I trial of ErepoXen® for the US and Canadian market, our long-acting erythropoietin which has been formulated using our PolyXen® technology to have an extended duration of activity. We look forward to this trial strengthing the clinical data available on ErepoXen® and building upon the recently announced positive Phase I results which have shown the product candidate to be safe and well tolerated with the potential to be administered on a once a month basis and competing in the $9 billion EPO marketToday's announcement highlights the growing momentum of Lipoxen's business, and the key role our portfolio of proprietary delivery technologies is expected to play in the generation of further deals and R&D collaborations throughout 2008.'


- ENDS -


Lipoxen PLC

M. Scott Maguire, Chief Executive Officer

+44 (0)20 7691 3583 

Landsbanki Securities (UK) Limited (nominated adviser)

Shaun Dobson / Claes Spång 

+44 (0)20 7426 9000

Citigate Dewe Rogerson

David Dible / Heather Keohane

+44 (0)20 7638 9571

Notes to Editors

Further information on 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 human insulin and ErepoXen®, 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.


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.

This information is provided by RNS
The company news service from the London Stock Exchange