A Phase I trial has found that PowderMed's monovalent influenza DNA vaccine successfully and safely delivered immunogenicity.
On the back of these results, published in the latest issue of the journal Vaccine (volume 24, issue 21), the UK firm will start Phase II studies using both annual and bird flu strains later this year.
The vaccine is delivered with the company's Particle Medicated Epidermal Delivery (PMED) needle-free injection system, which delivers DNA to the epidermal layer of the skin where it enters the cells of the immune network, creating immunity and facilitating both treatment and prevention of disease, said the firm.
"Recent years have seen a number of new influenza vaccine approaches tested in animal model systems and in the clinic, however, this study is the first successful demonstration of immunogenicity of an influenza DNA vaccine in humans," said Dr. Hansi Dean, from the International AIDS Vaccine Initiative.
"The relative immunogenicity of PowderMed's DNA vaccine compared to intramuscular DNA vaccination is likely attributable to the efficiency of intracellular DNA delivery by PMED."
According to the company, this delivery system is virtually painless, allows self-administration, requires no refrigeration for stockpiling, is uniquely and easily adaptable to treat avian flu and is an ideal vaccine to address the pandemic threat.
There is a surging demand for a widely available flu drug that is cheap to manufacture as worldwide governments prepare for a potential bird flu pandemic.
According to the World Health Organisation, approximately 200 people have caught the disease and 113 have died worldwide since its onset in Asia in 2003.
Recombinant DNA (rDNA) vaccine technology could be the answer as it represents a powerful tool for an innovative vaccine design process known as "genetic immunisation."
"DNA vaccines have the potential to significantly limit the burden of disease," Dr. Clive Dix, CEO of PowderMed.
"The advantage of a DNA-based approach is that the vaccines can be manufactured very rapidly and in large quantities, while yielding an efficacious immune response at low doses."
The flu vaccine is the first of a number of drugs delivered using the PMED technology coming through PowderMed's clinical pipeline.
The firm, focused on the clinical development and manufacture of therapeutic and prophylactic DNA-based vaccines for viral diseases and cancer, has three other Phase I clinical stage products in development - one for the treatment of genital herpes, one in cancer in partnership with the Ludwig Institute and one for HIV/AIDS in partnership with Glaxo SmithKline - as well as three pre-clinical stage products.