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Novel DNA-Based H5N1(Avian) influenza vaccine
Jul 10, 2006 - 7:26:00 PM, Reviewed by: Dr. Priya Saxena
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�Our approach provides a rapid route to vaccine development that can be applied to existing and emerging flu strains including, for example, the threat posed by a pandemic flu strain."
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By PowderMed,
PowderMed Ltd today announced that it has submitted regulatory documentation to the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for permission to conduct a clinical trial to test their proprietary H5N1 or avian influenza (bird flu) vaccine. It is planned that the trial will be conducted at a clinical research unit in London.
This new vaccine is based upon PowderMed�s proprietary system for delivering DNA vaccines � it is a needle-free injection device that fires gold particles coated with DNA (encoding genes specific to the flu strain) at supersonic speed into the immune cells of the skin. This first-time-in-man clinical trial will examine the ability of a vaccine based upon the Vietnam H5N1 avian influenza strain to protect against a potential pandemic form of flu.
A previous study, conducted by PowderMed in the United States, demonstrated that this vaccine technology was able to produce 100% protective immune responses in adult volunteers to a vaccine which encoded an annual influenza strain [Ref 1]. Using bird flu strains this vaccine has also shown 100% protection in various experimental models. Dr Beadle, PowderMed�s Chief Medical Officer, stated that �This is an exciting opportunity for PowderMed to conduct the first clinical trial on a vaccine which may have a very important role in the event of a future pandemic. We have selected this particular clinical unit in London to conduct the study because they are currently building up a database of volunteers for future influenza studies. This will allow us to conduct the study and get the results as quickly as possible once we have regulatory approval.� Full details of this clinical study and directions for potential volunteers can be found at www.clinicaltrials.gov
Dr Clive Dix, CEO of PowderMed also added: �Our approach provides a rapid route to vaccine development that can be applied to existing and emerging flu strains including, for example, the threat posed by a pandemic flu strain. DNA vaccines have a huge potential to limit the burden of disease and can be manufactured very rapidly, in large amounts: enough to vaccinate the whole of the UK population twice over (prime and boost) requires just 1Kg of DNA and can be manufactured and available in just three months from the point a strain is identified. We are very excited to see both our annual and pandemic influenza programmes progress through clinical development�. 
- PowderMed Limited
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, virtually 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�s influenza vaccines
PowderMed�s DNA vaccines are made up of two components � the vaccine-specific DNA and the
delivery device. 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.
PowderMed has two flu vaccines in development for annual and avian flu (H3 and H5 strains).
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.
The DNA vaccine consists of the standard DNA backbone with an immunologically active gene
specific to each viral strain � the gene cassette.
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