PowderMed reports publication of positive results from a Phase I study evaluating its proprietary prophylactic DNA influenza vaccine in the latest issue (volume 24, issue 21) of the journal Vaccine
Based on these results, PowderMed will start phase II studies using both annual and bird flu strains later this year.
Authored by lead researcher Hansi Dean, the report in Vaccine documents the safety and immunogenicity of PowderMed's monovalent influenza DNA vaccine delivered with the company's Particle Medicated Epidermal Delivery (Pmed) needle-free injection system.
The trial examined three doses of a DNA plasmid encoding the H3 haemagglutinin (HA) gene for Panama flu (1, 2 and 4 micrograms) administered as a single dose to 36 healthy adult volunteers.
Immune response was assessed according to criteria set by the Committee for Proprietary Medicinal Products (CPMP) for the approval of annual flu vaccines in the European Union.
Key findings include:.
At the maximum dose tested (4 micrograms), all subjects achieved a seroprotective level of antibodies demonstrating that this DNA vaccine is a viable candidate for expanded clinical evaluation as a potentially powerful defense against influenza and pandemic flu.
The maximum dose (4 micrograms) passed the CPMP criteria at 21 days and was well tolerated.
All three doses passed the CPMP criteria at 56 days.
"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 Hansi Dean, now with 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".
"The publication of this study in the prestigious journal Vaccine adds to the growing body of scientific evidence that PowderMed's DNA vaccine and the PMED platform show promise to address the major healthcare challenge posed by influenza, particularly in the event of an avian flu or other pandemic outbreak," said Clive Dix, CEO of PowderMed.
"DNA vaccines have the potential to significantly limit the burden of disease.
"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."
