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Lipoxen PLC (XEN)

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Monday 09 March, 2009

Lipoxen PLC

Sulixen Phase I Results

RNS Number : 5191O
Lipoxen PLC
09 March 2009

Lipoxen PLC

('Lipoxen' or 'the Company')

Lipoxen announces positive final data from its completed Phase I study with its long-acting insulin candidate, SuliXen

Data suggests SuliXen may have advantages over currently marketed insulin formulations

London, UK, 9th March 2009 - Lipoxen PLC (AIM:LPX) a bio-pharmaceutical company specialising in the development of high value differentiated biologicals, vaccines and oncology drugs, announces today positive results from its completed Phase I trial of SuliXen®, its long-acting insulin candidate for Type 1 and Type 2 diabetes. The data have shown SuliXen to be safe and well tolerated with no adverse events attributed to the product candidate being reported in the treated volunteers.

The Phase I cross-over study, which took place at the Federal State Center of Endocrinology in Moscow, Russia, involved 12 healthy volunteers, each receiving two doses of SuliXen (0.1IU/kg and 0.3IU/kg) as well as one dose of insulin glargine (Lantus, Sanofi-Aventis) dosed at 0.2IU/kg. This dosing regime was designed to allow a comparison with this commercially successful long-acting, insulin analogue. The data set announced today covers all of the treatments received by the 12 healthy volunteers taking part in the study. 

The study showed that both Sulixen, at both dosing levels, and insulin glargine, were well tolerated with no adverse events being observed during the Phase I trial.

The trial also provided data on SuliXen's pharmacodynamics. In the study (which involved 36 euglycemic hyperinsulinemic clamps), those who received SuliXen dosing of 0.1 IU\kg or 0.3 IU\kg and insulin glargine dosed at 0.2IU/kg showed a clear pharmacodynamic response, as demonstrated by the increased glucose infusion rate (GIR). Importantly, the SuliXen treated patients showed no significant peaks in GIR within the observation period of the study suggesting a peak-less profile for Sulixen. 

The trial also showed that SuliXen both at 0.1 IU\kg or 0.3 IU\kg was more potent than Lantus at 0,2 IU\kg. SuliXen has favorable pharmacokinetic profile, reaching maximum blood concentrations within 3 hours after subcutaneous injection and remaining in circulation up to 20-30 hours, depending from the dose injected. This was confirmed using an insulin immunoassay to measure insulin serum levels. 

These data demonstrate that with SuliXen, Lipoxen is well placed to achieve is goal of developing a  superior formulation to Lantus, the world'most-prescribed insulin which generated sales of $2.45  billion  in 20081.

SuliXen, long-acting insulin, is formulated using Lipoxen's proprietary PolyXen® technology. This  platform delivery technology, which has the potential to be applied to hundreds of biotherapeutics, both marketed and under development, is based on polysialic acid (PSA). PSA is a naturally occurring polymer which is biodegradable, non-immunogenic and non-toxic, and is expected to avoid the toxicity attributed to polyethylene glycol in PEGylated protein drug candidates. Key benefits of PolyXen® for protein drug delivery include reduced frequency and amount of dosage, prolonged pharmacological action and reduced immunogenicity and antigenicity. 

M. Scott Maguire, CEO of Lipoxen, said:

'The SuliXen data announced today shows that we are well on our way to developing a safe and novel insulin formulation that may well be more efficacious and provide a reduced dosing regime to currently marketed insulin products. This would make SuliXen an important new entrant into the $13 billion insulin market. With the World Health Organization expecting there to be over 300 million diabetes sufferers worldwide by 2025, there is a clear market need for improved long acting insulin formulations such as SuliXen. I look forward to updating you on Phase II results as well as about novel applications of SuliXen in the field of reversal and/or prevention of Type I diabetes expecting through the research with the world renowned Barbara Davis Center for Childhood Diabetes later this year. ' 

1. Sanofi-aventis Annual Results Presentation 2008



Lipoxen PLC

M. Scott Maguire, Chief Executive Officer

+44 (0)20 7691 3583 

Teathers (nominated adviser)

Claes Spång 

+44 (0)20 7426 9000

Citigate Dewe Rogerson

+44 (0)20 7638 9571

David Dible / Heather Keohane

Notes to Editors

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.

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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