From rxpgnews.com

Influenza
Novel DNA-Based H5N1(Avian) influenza vaccine
By PowderMed
Jul 10, 2006, 19:26

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”.

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