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Lipoxen PLC (XEN)

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Thursday 29 May, 2008

Lipoxen PLC

Phase I Results

RNS Number : 4565V
Lipoxen PLC
29 May 2008

Lipoxen PLC

('Lipoxen' or 'the Company')

Lipoxen announces positive Phase I data with its long-acting insulin

candidate, SuliXen

London, UK, 29 May 2008 - 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 a Phase I trial of SuliXen[R], its long-acting insulin candidate for Type 1 and Type 2 diabetes. The data have shown the candidate to be safe and well tolerated with no adverse events attributed to the product being reported in the treated patients.

The Phase I study, which is taking place at the Federal State Center of Endocrinology in Moscow, Russia, involves 12 healthy volunteers, each receiving two doses of SuliXen (0.1IU/kg and 0.3IU/kg) in comparison with a long-acting, insulin analogue - insulin glargine (Lantus, Sanofi-Aventis) dosed at 0.2IU/kg. The first data set reported here has been extracted from the first cohort of four patients with the next cohort to include eight patients. 

The trial also provided initial data on the product candidate's pharmacodynamics. In cohort 1 (which involved 12 euglycemic hyperinsulinemic clamps), those who received SuliXen dosing of 0.1 IU\kg or 0.3 IU\kg showed a clear pharmacodynamic responseas demonstrated by the increased glucose infusion rate (GIR), while insulin glargine at 0.2IU/kg failed to increase the GIR in some patients. The patients' individual pharmacodynamic responses both for SuliXen 0.1 IU\kg and 0.3 IU\Kg doses were greater than for 0.2 IU\kg of insulin glargineThese data demonstrate that Lipoxen is progressing towards the goal of having a superior formulation to Lantus, the world'most-prescribed insulin which generated sales of over $3 billion in 20071.

SuliXen, long-acting insulin, is formulated using Lipoxen's proprietary PolyXen[R] technology. This platform technology, which has the potential to be applied to hundreds of drugs, is based on polysialic acid (PSA), 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[R] 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 data announced today demonstrate that, with SuliXen, we are on our way to achieving our goal of developing a more efficacious insulin formulation with reduced dosing regime, with which we could become a recognised competitor in the $12 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 alternative insulin formulations such as SuliXen.' 

'These data build upon the recently announced positive Phase I results from our long-acting erythropoietin (EPO) candidate, ErepoXen[R], which demonstrated that the therapy could be suitable for once-monthly administration and competing in the $9 billion EPO market.' 

'With these data further confirming the validity of the Company's technology, this is a very exciting time for Lipoxen and we look forward to further positive results from our high value differentiated biologicals in the clinic'.


1. Sanofi-aventis Annual Report 2007


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

+44 (0)20 7638 9571

David Dible / Heather Keohane

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[R], long-acting EPO. These novel products, which are based on Lipoxen's proprietary PolyXen[R] 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[R] 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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