Healthcare Industry News: Rochester Medical
News Release - October 2, 2006
PowderMed to Conduct U.S. Clinical Trial of DNA-Based Annual Influenza VaccineStudy Will Assess Immunogenicity, Safety and Tolerability of New, Needle-Free Vaccine
OXFORD, U.K. & FREDERICK, Md.--(HSMN NewsFeed)--PowderMed, Ltd., today announced that it will begin testing a DNA-based annual influenza vaccine in a U.S.-based Phase I clinical trial. The study will assess the efficacy of a trivalent influenza vaccine administered to healthy adults using PowderMed's Particle Mediated Epidermal Delivery (PMED(TM)), a needle-free injection device that fires gold particles coated with DNA (encoding influenza virus genes) at supersonic speed into the immune cells of the skin.
Dr. John Treanor, M.D., Professor of Medicine, and of Microbiology and Immunology at the University of Rochester Medical Center and scientific advisor for this study, said, "This is an important trial of a vaccine that could represent a significant step toward a prophylactic vaccine against seasonal, as well as pandemic, influenza. PowderMed's DNA-based vaccine holds a great deal of promise and may present some real advantages for annual and pandemic protection due to rapid production and immunogenicity at low dosing."
The randomized, double-blind, dose-ranging study will assess the safety and tolerability of PowderMed's DNA influenza vaccine containing three plasmids encoding the HA genes from two "A" strains and one "B" strain, which are representative of the composition typically recommended for a seasonal influenza vaccine. The study will also assess the immunogenicity of the trivalent vaccine at different dose levels in terms of serum and mucosal antibody responses and cell-mediated immune (CMI) response.
"We look forward to the results of this study and are pleased to see our annual and pandemic influenza programs continue to progress through clinical development at a rapid, yet measured, pace," added PowderMed Chief Medical Officer Dr. John Beadle, M.D. "The data available from other research to date indicate that the safety and tolerability profiles of PMED DNA vaccines are highly appropriate for a product used in mass vaccination campaigns."
The study will be conducted by Quintiles Transnational Corp at their Phase I clinical research unit in Lenexa, KS and at BioKinetics in Springfield, MO. Potential volunteers interested in participating in this study at Quintiles may contact the recruiting line at 913-894-5533 and those interested in participating at BioKinetics may contact Brendon Bourg at 417-831-0456 or email@example.com. Additionally, details and directions are available at http://www.clinicaltrials.gov.
PowderMed's DNA-based influenza vaccines, including H3 and pandemic H5 strains, have shown consistent and robust immune responses in humans at micro-gram doses in previous clinical testing. A previous study, conducted by PowderMed in the U.S., demonstrated that PMED system was able to elicit 100 percent protective immune responses in adults to a vaccine which encoded an annual influenza strain.
PowderMed is a private immunotherapeutic company based in Oxford, U.K. 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 four clinical and three pre-clinical stage projects. The lead clinical program 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 programs in Cancer (Ludwig Institute) and HIV/AIDS (Glaxo SmithKline). PowderMed vaccines are delivered using Particle Mediated Epidermal Delivery (PMED), 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. For more information, please visit: http://www.powdermed.com.
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