Positive Flu Vaccine Data
April 30 2009 - 2:01AM
UK Regulatory
TIDMLPX
RNS Number : 4268R
Lipoxen PLC
30 April 2009
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| For immediate release | 30 April 2009 |
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Lipoxen plc and Cambridge Biostability Ltd
Positive Data for Revolutionary Influenza Vaccine
Suitability for stockpiling in preparation for H1N1 flu pandemic
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, and Cambridge Biostability Ltd (CBL), the developer
of temperature stable vaccines and biopharmaceuticals, are pleased to announce
that they have achieved positive preclinical results for the delivery of a novel
and enhanced influenza vaccine based on the combination of Lipoxen's novel
vaccine delivery system 'ImuXen' and CBL's proprietary VitRIS stabilisation
platform.
The study results show that ImuXen increases the effectiveness of influenza
vaccine materials by approximately 30-fold. In addition, the VitRIS formulation
enhances the efficacy of the vaccine a further 4-fold. As a combined product,
the VitRIS-preserved ImuXen formulation has the potential to achieve a
projected 10-fold advantage in vaccine production rates, addressing the greatest
potential need for seasonal and pandemic influenza vaccines for existing and
newly emerged flu viruses.
Highlights of the results:
* ImuXen shown to increase the effectiveness of influenza vaccines by
approximately 30-fold
* VitRIS formulation enhances the efficacy of the vaccine by a further 4-fold
* Potential to radically increase output of vaccine doses from existing
manufacturing facilities - projected 10-fold advantage in vaccine production
rates
* No requirement for 'cold-chain' of refrigerated trucks, warehouses and fridges
The study, which was undertaken by Lipoxen and CBL with analysis of blood
samples conducted by Retroscreen Virology Ltd in London, was set up to determine
the capability of Lipoxen's ImuXen technology, in combination with CBL's VitRIS
stabilisation technology, to create a stable vaccine formulation that would
increase antibody production against an H1N1 Influenza virus which was supplied
by the UK National Institute for Biological Standards and Control (NIBSC), the
Government body responsible for safeguarding and advancing public health by
assuring the quality and safety of biologicals. Data from the study was
independently reviewed by Professor Will Irving, a Consultant Virologist at
Nottingham University's Queen's Medical Centre and a leading UK virologist who
has worked on influenza for over 15 years.
Lipoxen, in association with CBL and with funding from the Technology Strategy
Board (formerly the DTI), have created a novel water-free influenza vaccine
formulation, that will be heat and freeze stable and will not require
refrigeration during transport, storage and distribution.
Lipoxen's ImuXen technology entraps regular flu vaccine material (killed virus
particles) into the Company's proprietary liposomes to provide an enhanced
antibody response compared to a regular vaccine formulation. CBL's VitRIS
technology enables the liposomes to be dried and stabilised within microscopic
particles of sugar glass which can then be suspended in a user-friendly
biocompatible oil. The thermostable liquid vaccine is then ready for immediate
injection and has the added advantage that it can be used for long term
stockpiling.
The results of the study give clear indication that Lipoxen's vaccine technology
coupled with CBL's formulation techniques, not only provide a significantly
enhanced vaccine response but also a dramatic advantage in increased vaccine
production rates.This advantage addresses the greatest need of seasonal and
pandemic influenza vaccines based on newly emerged flu viruses, such as the
recent swine flu outbreak..
Following the study results, Lipoxen have selected a lead vaccine candidate and
are currently conducting stability studies at elevated temperature in
partnership with CBL.
Lipoxen and CBL are also in discussion with major vaccine manufacturers with a
view to licensing the new technology package for pandemic and seasonal influenza
vaccines.
Commenting on the announcement, M. Scott Maguire, CEO of Lipoxen, said:
"This new very positive data on a novel flu vaccine candidate comes at a
critical time for the World particularly in light of the current potential for
a swine flu outbreak where the death toll is climbing daily and the spread of
disease is an enormous current global threat. These results show that we have
the technology to develop a novel flu vaccine candidate suitable for pandemic
planning. Our vaccine candidate offers the advantages of enhanced immune
response, fast and high volume production as well as no requirement for a
cold-chain, all ideal characteristics in planning for further pandemic
situations. Based on the results we are encouraged to believe that it would also
work for the new swine flu 2009 strain since an earlier human derived H1N1
strain was used in the studies reported today. We look forward to working with
CBL to maximise the commercial potential of this flu vaccine candidate."
Also commenting on this announcement, Dr David Moss, Director of Research
at Cambridge Biostability, said:
"We are delighted that our VitRIS technology has allowed the development of a
thermo-stable, instantly injectable vaccine against influenza. Thermostability,
the removal of reliance upon the cold chain, coupled with the fact that the
vaccine needs no reconstitution prior to injection are two major steps forward
in the development of the next generation of vaccines and other biologics aimed
at both the developing and developed world markets."
Adding to this, Professor of Virology Will Irving, an independent Consultant
Virologist at Nottingham University's Queens Medical Centre, said:
"This new influenza vaccine formulation has generated some very exciting data.
The potential to generate protective antibody responses whilst using
surprisingly low doses of antigen is a major potential breakthrough - in the
H5N1 vaccine field, published data suggest that prohibitively large doses of
antigen may be needed in order to generate protective responses. The novel
delivery vehicle, showing stability at ambient temperatures, will also be a huge
benefit, allowing delivery of vaccine in situations which otherwise would
experience great difficulties in achieving successful transport and storage of
traditional vaccine preparations."
For further information:
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| Lipoxen plc | +44 (0)20 7691 3583 |
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| M. Scott Maguire, Chief Executive Officer | |
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| | |
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| Cambridge Biostability Ltd | +44 (0)1223 437400 |
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| Kiran Gulati, Director of Business Development | |
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| | |
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| Singer Capital Markets (nominated adviser) | +44 (0)20 3205 7500 |
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| Jeff Keating / Claes Spång | |
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| | |
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| Noble & Company | +44 (0) 20 7763 2200 |
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| John Llewellyn-Lloyd / Sam Reynolds | |
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| | |
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| Buchanan Communications | +44 (0)20 7466 5000 |
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| Mary-Jane Elliott, Lisa Baderoon, Rebecca Skye | |
| Dietrich, Catherine Breen | |
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Notes to Editors
About Influenza and reasons for the study
Influenza has been established as a serious human affliction that can cause
localised epidemics and global pandemics of acute respiratory infections. Each
year the Influenza virus is responsible for 20,000 to 40,000 deaths and up to
300,000 hospitalisation cases in the United States (Sandhu & Mossad, 2001). In
the pandemic of 1918 it is widely believed that in excess of 40 million people
died.
Although children and younger adults experience more cases of infection,
severe illness is more common in the elderly, immunocompromised individuals, or
those with chronic illnesses such as asthma, diabetes, kidney failure and heart
disease. (Stamboulian et al., 2000).
The annual epidemics run from November to March in the Northern Hemisphere,
and from April to September in the Southern Hemisphere (Cox & Subbarao,
2000). The impacts of these viruses have led to the search for alternative
compounds with which to minimize their effects within human populations.
Immunisation, with current inactivated vaccines given parentally, is effective
at reducing mortality, attenuating the symptoms of the disease, and minimising
the sequelae associated with Influenza. It has also been proposed that
immunisation of young children, identified as enhancing ongoing viral
transmission in communities (Reichert, 2002; Reichert et al., 2001), might
significantly reduce the spread of Influenza virus in the community. Therefore,
the development of an efficacious highly tolerable vaccine, suitable for all
members of a community would be of great benefit.
The majority of current vaccines have several limitations, including
non-biodegradability, a depot effect, inflammation and induration at the site of
injection, and either a weak, or no, cellular immune response. Attempts to
increase antibody response by increasing the antigen content per dose have not
always resulted in improved immunogenicity (Couch et al., 1997).
About Lipoxen
Lipoxen plc (AIM: LPX) is a biopharmaceutical company specializing in the
development of high value differentiated biologicals, vaccines and siRNA
delivery. 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 long-acting EPO. These novel products, which are based
on Lipoxen's proprietary PolyXen 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 and a
related liposomal technology to enhance the efficacy and safety of various
vaccines such as a multivalent Hepatitis B-E, HIV and pneumococcal vaccines. The
Company has a third technology, siRNAblate for the delivery of siRNA. The
Company's proprietary delivery technologies are attracting significant interest
from the world's largest biopharma companies 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 Schering-Plough and a grant for development of a novel HIV
vaccine candidate from International AIDS Vaccine Initiative (IAVI), the world's
leading AIDS vaccine organization.
Lipoxen was admitted to trading on the AIM Market of the London Stock Exchange
in January 2006. For more information please visit
www.lipoxen.com.www.lipoxen.com.
About Cambridge Biostability Ltd
Cambridge Biostability Ltd is a biotechnology company which has developed unique
expertise and technologies that enable the formulation of a wide range of
vaccines, both live and inactivated, and other biologics, including monoclonal
antibodies, nucleic acids, growth factors and hormones, into thermo-stable,
instantly injectable formats requiring no refrigeration or reconstitution.
CBL's technology is based on two main platforms - VitRISTM and HydRIS , both of
which use glass-forming excipients to enable the development and production of
"user-friendly" biopharmaceuticals.
Temperature stability offers significant benefits as it increases
shelf-life, reduces the cost of administration and storage, enables efficient
and economic stockpiling to meet sudden increases in demand and enables
treatment for patients in the field without the need for expensive and often
logistically difficult refrigeration.
The Company has filed several patent families worldwide and has a portfolio of
development programmes underway including a US Government (NIAID)-funded
study in collaboration with DynPort Vaccine Company to develop a stable,
multivalent vaccine against botulism and a collaborative research programme with
the University of Oxford, funded by the Bill and Melinda Gates Grand Challenge
Fund, aimed at creating safe, easy to administer, thermo-stable vaccines for
HIV, malaria and tuberculosis.
To learn more about CBL please visit our web site at www.biostability.com
This information is provided by RNS
The company news service from the London Stock Exchange
END
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