Information  X 
Enter a valid email address

Lipoxen PLC (XEN)

  Print      Mail a friend

Wednesday 13 February, 2008

Lipoxen PLC

Phase I EPO study initiated

Lipoxen PLC
13 February 2008

This announcement replaces RNS announcement 8702N issued on 13 Feb 2008


                                  Lipoxen PLC
                          ('Lipoxen' or 'the Company')

 Lipoxen announces that its partner Serum Institute of India has begun Phase I
               trials of long-acting erythropoietin (EPO)


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


London, UK, 13 February 2008 - Lipoxen PLC, (AIM:LPX) a bio-pharmaceutical
company specialising in the development of high-value differentiated
biologicals, vaccines and oncology drugs, announces today that its partner,
Serum Institute of India, has began dosing patients in a Phase I trial of
ErepoXen(R), a long-acting EPO. This product candidate, which will be used to
treat anaemia in patients receiving renal dialysis, has been formulated using
Lipoxen's proprietary PolyXen(R) delivery technology. Current EPO therapies are
generally administered between once and three times a week. The aim of this
trial is to demonstrate the benefits of ErepoXen's sustained-release
characteristics as compared to current EPO drug products.

The Phase I trial, which is taking place at Veeda Clinical Research Pvt in
India, is a randomised double-blind placebo-controlled single dose study. The
trial is designed to assess the safety, tolerability and efficacy of EPO
formulated using Lipoxen's proprietary PolyXen(R) technology. This technology is
based on polysialic acid (PSA), a naturally occurring polymer which extends a
protein's active life, is biodegradable, non-immunogenic and non-toxic, and
which is also expected to avoid the toxicity attributed to polyethylene glycol
in PEGylated protein drug candidates. 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 that the results of this Phase I clinical trial will be
available in April 2008.  Lipoxen's development partner, the Serum Institute of
India, is the world's largest producer of vaccines. It is estimated that two out
of every three children immunised in the world are vaccinated with a Serum
Institute vaccine.

M. Scott Maguire, CEO of Lipoxen, said:

'We are pleased that our partner Serum Institute has initiated this Phase I
trial of long-acting erythropoietin which has been formulated using our PolyXen
(R) technology to have an extended duration of activity. This is an important
milestone in the development of Lipoxen's overall product pipeline as it is the
first clinical trial that Serum Institute has undertaken using a product based
on our proprietary delivery technology. In 2007, the overall global market for
EPO was worth $9 billion. However, there is a clear demand from patients for
improved forms of EPO, which have in particular less frequent dosing and more
patient convenience. Today's announcement highlights the growing momentum of
Lipoxen's business with the first clinical data for our two most advanced
high-value differentiated biologicals expected before mid 2008. In addition, the
potential benefits of our portfolio of delivery technologies are attracting
interest from a growing list of potential partners and we anticipate signing
further licensing deals with pharma and biotech companies who are in need of
improved delivery solutions for their biologics during the course of 2008.'





                                      Ends


Enquiries


Lipoxen PLC
M. Scott Maguire, Chief Executive Officer          +44 (0)20 7691 3583

Landsbanki Corporate Finance (nominated adviser)   +44 (0)20 7426 9000
Shaun Dobson / Claes Spang

Citigate Dewe Rogerson                             +44 (0)20 7638 9571
David Dible / Emma Palmer


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 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.





Further information on Serum Institute



Lipoxen's development partner, the Serum Institute of India, is the world's
largest producer of vaccines. It is estimated that two out of every three
children immunized in the world are vaccinated with a Serum Institute vaccine.
Serum Institute's products have been supplied to international health agencies
like the WHO, UNICEF and PAHO. Serum Institute's products are exported to more
than 140 countries across the globe. Under the terms of its product development
agreement with Lipoxen, Serum Institute is responsible for the clinical
development and commercialisation in the developing world for a number of
biologicals and vaccines that have been reformulated using Lipoxen's suite of
delivery technologies.



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