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LPX Lipoxen

7.875
0.00 (0.00%)
29 Jul 2024 - Closed
Delayed by 15 minutes
Share Name Share Symbol Market Type Share ISIN Share Description
Lipoxen LSE:LPX London Ordinary Share GB00B08NWV55 ORD 0.5P
  Price Change % Change Share Price Bid Price Offer Price High Price Low Price Open Price Shares Traded Last Trade
  0.00 0.00% 7.875 0.00 01:00:00
Industry Sector Turnover Profit EPS - Basic PE Ratio Market Cap
0 0 N/A 0

Phase I Results

21/04/2008 8:00am

UK Regulatory


RNS Number:6713S
Lipoxen PLC
21 April 2008


  Lipoxen Announces Positive Phase I Results with its Long Acting EPO Product
                           Candidate - ErepoXen(R)

   First positive human clinical data demonstrates the potential of Lipoxen's
       PolyXen(R) technology to enhance the delivery of a broad range of
                                biotherapeutics


London, UK, 21 April 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 initial results from the
first Phase I trial of ErepoXen(R), a long-acting EPO. This trial, which was
conducted by Lipoxen's partner, Serum Institute of India, showed that the
product candidate was well tolerated and has the potential to be administered on
a once monthly basis. Current EPO therapies are generally administered between
once and three times a week and hence ErepoXen(R) could provide a much improved
dosing regime for patients. ErepoXen(R), which is being developed to treat
anaemia in patients receiving renal dialysis, has been formulated using
Lipoxen's proprietary PolyXen(R) delivery technology which is also being used in
the development of a series of other product candidates

The Phase I trial, which was carried out at the Veeda Clinical Research Pvt in
India, was a randomised double-blind placebo-controlled single dose study. The
trial was 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 recruited 32 healthy adult
males, 24 of whom received ErepoXen(R) while eight received placebo, via
subcutaneous injection. The patients who received ErepoXen(R) were assigned to
two groups one of which received 0.5 micrograms/kg (body weight) and the other
received 1.5 microgram/kg.

The initial results from the Phase I study show that ErepoXen(R) is safe and
well tolerated with no adverse events attributed to the product being
experienced in any of the treated patients. The trial also provided initial data
on the product candidate's pharmacokinetics. In the patients receiving the
higher dose of ErepoXen(R) there was a clear reticulocyte (immature red blood
cells) response which lasted for two weeks. In addition, there was a sustained
rise in haemoglobin levels which lasted for 28 days in these patients.

Commenting on the results, Dr. Mikhail Ashraf, Consultant Nephrologist and
Senior Medical Tutor, Swansea University, said, "These results from early
cohorts are very encouraging. The 28 day sustained haemoglobin rise and the
lasting reticulocyte response indicate that this preparation could be suitable
for once monthly administration. With most current erythropoietin therapies
administered between once and three times a week, ErepoXen(R) has the potential
to fulfill a large unmet medical need in anaemia management and I look forward
to following its development."

M. Scott Maguire, CEO of Lipoxen, said:

"We are extremely pleased that the initial results from the first Phase I trial
with ErepoXen(R) have been so positive. The study has shown the product
candidate to be safe and well tolerated, and also demonstrates that this
long-acting erythropoietin, which has been formulated using our proprietary
PolyXen(R) technology, has the potential to be administered on a once a month
basis. This could be a key competitive advantage for ErepoXen(R) as there is a
clear demand from patients for improved forms of EPO, which have, in particular,
less frequent dosing and more patient convenience. In 2007, the overall global
market for EPO was worth $9 billion.

Today's announcement is a major milestone for Lipoxen's business as it is the
first human data showing that we can use our PolyXen(R) technology to improve
the delivery of biological drugs, a growing and highly profitable segment of the
overall pharmaceutical market. We are currently conducting a Phase I study with
our long-acting insulin product SuliXen and I am confident that this study will
also produce a positive outcome. With two high-value differentiated biologicals
under development and a portfolio of delivery technologies which is attracting
interest from a growing list of potential partners, I believe that Lipoxen is
well positioned to generate significant shareholder value over the remainder of
2008."

                                    - ENDS -

Enquiries

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

Landsbanki Securities                                +44 (0)20 7426 9000
Shaun Dobson / Claes Spang

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.


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