Study in the Journal VACCINE Reports Positive Results of DNA-Based Flu
Vaccine in Humans
BIOWIRE2K
OXFORD, United Kingdom and FREDERICK, Md.--(BUSINESS WIRE)--May 31,
2006--PowderMed, Ltd. today announced the 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 Dr. 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 Dr. 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 Dr. 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."
VACCINE is the pre-eminent journal for those interested in vaccines
and vaccination. It serves as an interface between academics, those in
research and development, and workers in the field. Relevant topics
range from basic research through to applications, safety and
legislation.
About PowderMed
PowderMed (http://www.powdermed.com/) 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.
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 GBP 20 million in venture financing to date, with an
additional GBP 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.
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Positive Results of DNA-Based Flu Vaccine in Humans
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