Oxford, UK, 1st August 2005
- PowderMed, the immunotherapeutics company focused on the development and
manufacture of DNA-based vaccines for viral diseases and cancer, has
announced that it has progressed its H5N1 Avian Influenza Vaccine
programme into the final stages of preclinical development. PowderMed has
produced an H5N1 vaccine by cloning the H5 gene from the current
circulating avian flu strain (“the gene cassette”) into the company’s
proprietary DNA vaccine backbone and the vaccine is now ready for
development. Manufacturing and toxicology studies are now in progress, and
it is anticipated that this vaccine will enter clinical trials by the
middle of 2006.
Commenting on the
programme, Dr Clive Dix, CEO of PowderMed said:
“We are very excited by
the potential for our flu vaccine technology to address the major
healthcare challenge that influenza presents, in particular in the event
of an avian flu or other pandemic outbreak. Our technology has significant
advantages over current flu vaccine technology particularly in terms of
the speed of response in the event of a pandemic. As soon as a new
influenza strain becomes known, our “plug and play” system would enable us
to rapidly insert the relevant DNA gene cassette into our standard DNA
backbone. A PowderMed manufacturing facility will be capable of
delivering the vaccine requirements of an entire country within 3 months.
This is not possible for other technologies.”
Just 1.2kg of vaccine
DNA would be sufficient to vaccinate the entire population of the US twice
- an initial dose and a booster dose. PowderMed has carried out a detailed
feasibility study with contract manufacturing partners, which concludes
that it could establish a manufacturing capability with a surge capacity
of 150 million influenza vaccine doses in a three-month period. Dr Dix
points out that this is critical since, “No other vaccine technology
offers this speed of response. In the event of a pandemic, most deaths and
illness will occur in the first six months of an outbreak. We believe that
our technology offers the best potential to save lives and minimise the
economic impact of a flu pandemic.”
The Avian flu vaccine
uses the same standard DNA vaccine backbone as PowderMed’s annual flu
vaccine, which has already successfully completed a Phase I clinical trial
(www.powdermed.com/media.htm)
and will enter Phase IIb trials in 2006.
-ends-
NOTES FOR EDITORS
About PowderMed Ltd –
www.powdermed.com
PowderMed is a private immunotherapeutic
company based in Oxford, UK. The Company is focused on the clinical
development and manufacture of therapeutic and prophylactic DNA-based
vaccines for viral diseases and cancer. The company has 4 clinical and 3
pre-clinical stage projects. The lead clinical programme has shown
positive Phase I results in the treatment and prevention of human
influenza. This technology is uniquely and easily adaptable to treat avian
flu and to address the pandemic threat. PowderMed also has a product for
the treatment of genital herpes in Phase I trials, and two partnered Phase
I programmes in Cancer (Ludwig Institute) and HIV/AIDS (Glaxo SmithKline).
PowderMed vaccines are delivered using PMEDTM (Particle
mediated epidermal delivery), a needle-free, painless delivery system that
requires minimal medical training, allows self-administration and requires
no refrigeration for stockpiling. Specifically, PowderMed’s technology
delivers DNA to the epidermal layer of the skin where it is presented to
the cells of the immune network, thereby creating immunity and thus
facilitating both treatment and prevention of disease.
PowderMed has adopted a flexible and cost
effective business strategy: company resources are used for discovery
research and drug design with outsourced partners being used for its drug
development and manufacturing requirements. The Company has a highly
experienced management team that has a combined 160 years of experience,
with Rolf Stahel as the chair of the board. The Company has sufficient
funds through to the end of 2006 having raised £20 million in venture
financing to date, with an additional £5 million available from its
existing investor syndicate that comprises Abingworth Management, Advent
Venture Partners, Isis College Fund, Oxford Bioscience Partners and SV
Life Sciences.
PowderMed’s pandemic
influenza vaccine
PowderMed DNA vaccines are made up of two
components – the vaccine-specific DNA and the delivery device. The DNA
vaccine consists of the standard DNA backbone with an immunologically
active gene specific to each viral strain – the gene cassette. The
delivery device is a fully developed and patented system, called Particle
Mediated Epidermal Delivery (PMED™), whereby gold particles coated in the
vaccine DNA are propelled into the skin using high-pressure helium. In
this way, vaccine DNA is delivered directly to cells of the immune network
in the skin, thereby stimulating immunity. This approach provides a rapid
route to vaccine development that can be applied to existing and emerging
flu strains including, for example, the threat of the emergence of a
pandemic flu strain.
In the case of the Avian flu vaccine, the H5
Vietnam gene cassette is used. This gene is specific to current Avian flu
and encodes part of the flu virus’ protein shell. When the vaccine is
administered, into the surface of the skin, the H5 gene is expressed to
produce the virus protein. This harnesses the individual’s immune system
to mount an immune response against the protein, such that, in the event
of later exposure to actual Avian flu virus, the immune system will be
able to destroy the flu virus and thus provide protection.
Results of previous preclinical and clinical
testing of PowderMed’s DNA-based influenza vaccines, including H3 and
pandemic H5 strains utilising PMED, show consistent and robust immune
responses in animals and humans at micro-gram doses.
Using PowderMed’s technology, vaccination is
needle free, virtually painless, can be easily administered without the
need for trained medical personnel and it can be stored at room
temperature making it ideal for large volume stockpiling and distribution.
The Company has developed a full clinical
trial and manufacturing strategy that anticipates the demands that
Governments may have for both annual influenza vaccine and a pandemic flu
vaccine.
Background to Influenza
Flu is an acute viral infection of the
respiratory tract caused by the Influenza virus. There are many different
subtypes or strains of Influenza viruses, differentiated by proteins on
the surface of the virus: the hemagglutinin or “HA” protein and the
neuraminidase or “NA” protein. So far, 15 H and 9 N subtypes have been
identified.
These viruses continually change over time
and every year small modifications (“antigenic drifts”) are responsible
for seasonal outbreaks or “epidemics” of Influenza. Worldwide, an
estimated 100,000 hospitalisations and about 20,000 deaths occur each year
from the flu or its complications (source: The National Institute of
Allergy and Infectious Diseases).
Abrupt genetic recombinations of HA and/or
NA proteins on the surface of the virus (“antigenic shifts”) result in the
emergence of a new virus, which is a key step towards a pandemic strain.
To date, there is little evidence that the H5N1 virus (associated with
Avian flu) is capable of spreading from human to human, a pre-requisite
for a pandemic strain, but should recombination (antigenic shift) of H5N1
occur, this strain could become responsible for a global outbreak of the
disease or pandemic, with high levels of illness and death. The WHO (World
Health Organization) has reported 97 human cases of avian flu since 26
December 2003. Since that date 53 deaths have been reported.
Previous Influenza pandemics:
–1918-1919 “Spanish flu” (H1N1) with up to
50 millions deaths worldwide.
–1957-1958 “Asian flu” (H2N2) caused about
70,000 deaths in the US
–1968-1969 “Hong Kong flu” (H3N2) caused
about 34,000 deaths in the US
Both the 1957-1958 and the 1968-1969
pandemics were caused by viruses containing combinations of human and
avian Influenza viruses.
PowderJect®
Particle Mediated Epidermal Delivery (PMED™) technology
Using the PowderJect device, DNA
precipitated onto microscopic gold particles is propelled by pressurised
helium gas at near supersonic speeds into the epidermis. The microscopic
gold particles (mean particle diameter 1 - 3 microns) are used as the
carrier because they have the appropriate size and density needed to
deliver the DNA directly into the immunologically active antigen
presenting cells (APCs) of the epidermis. These cells have a mean diameter
of 20 microns and thus the microscopic gold can easily enter the cell.
Studies have shown that once inside the nuclei of APCs, the DNA elutes off
the gold and becomes transcriptionally active, producing the encoded
protein that, when presented by the APCs to lymphocytes, triggers strong
T-cell mediated immune responses. It is this ability of PMED to produce a
robust and reproducible T-cell mediated immune response to a broad range
of viral and cancer antigens, that provides PowderMed with its unique
competitive advantage in the field of DNA-based vaccines.
For a high resolution
image please contact Adam Michael at Northbank Communications on:
Tel.: +44 (0) 20 7886 8150 or by email at
a.michael@northbankcommunications.com.
Further enquiries:
Northbank Communications
Ltd
Sue Charles, Adam
Michael, Dr Christelle Kerouedan
Tel:
+44 (0)20 7886 8150
s.charles@northbankcommunications.com,
a.michael@northbankcommunications.com,
c.kerouedan@northbankcommunications.com
PowderMed Ltd
Dr Clive Dix
Tel: +44 (0)1865
501 549
clive.dix@powdermed.com
