TIDMLPX
RNS Number : 5049U
Lipoxen PLC
18 October 2010
For Immediate Release 18 October 2010
LIPOXEN
LATEST RESULTS ON PROPRIETARY INFLUENZA VACCINE
-- Project results validate positive Efficacy findings for
Proprietary Influenza Vaccine candidate
-- Company advancing plans to take product candidate into Phase
1 clinical trials within 24 months.
-- Initiation of search for commercial collaboration to
accelerate product development.
Lipoxen plc (AIM: LPX), ('Lipoxen' or 'the Company') a
bio-pharmaceutical company specialising in the development of
high-value differentiated biologicals, vaccines and siRNA delivery,
announces positive efficacy results for its novel influenza vaccine
using its liposomal co-delivery technology "ImuXen" and is
advancing plans to capitalise on this pre-clinical success in order
to accelerate the candidate into the clinic within 24 months.
While Lipoxen has provided interim updates to the market on this
Technology Strategy Board part-funded project, the agreed project
plan has now been successfully concluded with the positive outcome
that the Lipoxen formulation induced protective immunity against
challenge with live virulent influenza virus after a single
vaccination in a mouse model. Importantly, the formulation did not
require the addition of an adjuvant and contained considerably less
protein antigen than current flu vaccines. Furthermore, a spray
dried version of the vaccine was still efficacious even after
storage at 37[deg]C for 6 weeks indicating that there is the
potential to create a formulation that can withstand storage
outside of the cold chain.
In April 2009 the Company announced positive pre-clinical data
in respect of this proprietary influenza vaccine candidate, noting
that:
1. The ImuXen technology platform, as applied to an influenza
vaccine had shown an increase in the effectiveness of influenza
vaccines of approximately 30-fold.
2. The technology has the potential to radically increase output
of vaccine doses from manufacturing facilities to confer an
advantage of up to 10 times existing vaccine production rates - a
major benefit when addressing the challenges to human health in
situation of both pandemic and seasonal outbreaks.
3. The technology avoids the need for "cold chain" storage and
distribution as in its dried form it is stable for long periods at
high temperatures
Lipoxen stated at that time that it was necessary to undertake
further studies to specifically validate the significant advantages
that a novel influenza vaccine produced using the ImuXen platform
technology could deliver. These were focused on three key
areas:
(a) Economies of production through the use of less antigen.
(b) The ability to confer single-shot immunity
(c) The ability to deliver a cost effective and storage and
handling stable product able to be effectively dosed in tropical
and sub-tropical climates.
In short, these latest project results have validated all of the
major benefits announced 18 months ago and, based on them, the
Company has moved directly to seek EU grant funding to assist in
meeting the costs of undertaking a full GMP manufacturing and GLP
toxicity, safety and efficacy programme ahead of the Company's
planned route to Phase I (safety) studies in man.
Subject to the availability of capital - whether internally,
from EU grant funding or through commercial partnering Lipoxen has
targeted submitting its clinical trial application in Q4 2012.
Commenting on the announcement, Scott Maguire, CEO said:
"While the vaccine used in this project was designed to mimic
current single-strain pandemic vaccines, the ImuXen platform allows
the development of multi-valent vaccines with the potential to
address the combined demands of therapeutic efficacy and cost
effectiveness, the latter being in the light of the continuing
demands of governments and other health care payers to reduce the
cost of public healthcare.
These trial results have underpinned our belief in the long term
viability of the ImuXen platform for the development and efficient
production of a broad spectrum of vaccine therapies, and have
wholly vindicated our early optimism for both the ImuXen technology
in general and the influenza vaccine candidate in particular. We
are now actively taking steps to commercialise this opportunity in
parallel with seeking EU grant funding to take this important
proprietary product into the clinic as soon as possible.
While a specific influenza product may yet be some years away
from any market launch - and by no means taking lightly the
challenges of clearing the many clinical hurdles to be overcome
along the way - the Company has now put a clear line in the sand
over the real commercial potential vested in the ImuXen platform
which can now look to sit alongside our PolyXen technology which
has already shown such great promise in both clinical trials and
with our leading commercial collaborator, Baxter Healthcare.
I believe that these results put Lipoxen firmly on the map as a
leading European platform technology company with the potential to
offer a full range of delivery solutions for both biologic and
vaccine therapies, be this for next generation drugs and vaccines
or for patent protected bio-superior products."
- Ends -
For further information, please contact:
Enquiries
Lipoxen plc +44 (0)20 7389 5015
M. Scott Maguire, Chief Executive Officer
Singer Capital Markets (nominated adviser) +44 (0)20 3205 7500
Jeff Keating / Claes Spang
Buchanan Communications +44 (0)20 7466 5000
Lisa Baderoon, Mark Court, Jessica Fontaine
About Lipoxen
Lipoxen plc is a biopharmaceutical company focused on the
development of new and improved biologic drugs and vaccines.
Lipoxen has three proprietary patented technology platforms:
1) PolyXen - for extending the efficacy and half life of
biologic drugs
2) ImuXen - for creating new vaccines and improving existing
vaccines
3) SiRNAblate - for the delivery of siRNA
Lipoxen's technology is designed to improve the efficacy,
safety, stability, biological half-life and immunologic
characteristics of its products.
Lipoxen has multiple drug and vaccine programmes in development.
Two products are in clinical development, SuliXen, a long acting
insulin and ErepoXen, a long-acting erythropoietin (EPO). Lipoxen's
preclinical pipeline includes vaccines against HIV, influenza and
malaria and an exclusive license deal with Baxter Healthcare for
blood coagulation drugs.
The Company has a low-risk business model and out-licenses its
proprietary technologies to biopharmaceutical companies that have
strong manufacturing and marketing capabilities. Lipoxen currently
has commercial agreements with some of the world's leading
biotechnology and pharmaceutical companies including Baxter,
Schering-Plough, the Serum Institute of India Limited, Genentech,
and Genzyme. Furthermore, Baxter, the Company's third largest
shareholder, and management led the GBP2.9 million fundraising that
the Company announced in May 2009. This fundraising was followed up
by a GBP1.2 million placing in April 2010 which was led by the
Company's management team.
Lipoxen, which was founded in 1997, trades on the AIM Market of
the London Stock Exchange under the ticker symbol LPX. More
information can be found at the Company's website:
www.lipoxen.com.
About the Technology Strategy Board
The Technology Strategy Board is a business-led executive
non-departmental public body, established by the government. Its
role is to promote and support research into, and development and
exploitation of, technology and innovation for the benefit of UK
business, in order to increase economic growth and improve the
quality of life. It is sponsored by the Department for Business,
Innovation and Skills (BIS). For further information please visit
www.innovateuk.org
This information is provided by RNS
The company news service from the London Stock Exchange
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