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 IUkg or 0.3 IUkg showed a clear pharmacodynamic response, as
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 IUkg and 0.3 IUKg doses were greater than for 0.2 IUkg of insulin
glargine. These data demonstrate that Lipoxen is progressing towards the goal of having a superior formulation to Lantus, the world's
most-prescribed insulin which generated sales of over $3 billion in 20071.

    SuliXen, a 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 a 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".


    Ends
    1. Sanofi-aventis Annual Report 2007

    Enquiries 

 Lipoxen PLC
 M. Scott Maguire, Chief Executive Officer               [phone] 

 Landsbanki Securities (UK) Limited (nominated adviser)
 Shaun Dobson / Claes Spg                                [phone]

 Citigate Dewe Rogerson                                  [phone]
 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.

This information is provided by RNS
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