Cyto Pulse and the Center for Vaccine Development Received IRB Approval for Study of Easy Vax
News Feb 12, 2009
Cyto Pulse Sciences has announced ethical committee approval for the Phase I medical device study to investigate the safety and tolerability of the Easy Vax™ Clinical Epidermal Electroporation System in healthy volunteers.
The study, funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, will be conducted by investigators at the Center for Vaccine Development, University of Maryland School of Medicine.
“This is another step in the development of our DNA vaccine delivery system, Easy Vax™,” said Richard Walters, Cyto Pulse CEO. “The Easy Vax™ system is designed to be safe, effective for use in a broad range of environments and populations.”
“A major obstacle to the widespread use of DNA vaccines has been the availability of light-weight, portable and safe devices for vaccine delivery. DNA vaccines are well tolerated and can be readily manufactured at low cost for a wide variety of infectious diseases. This Phase I trial will allow us to test the safety and tolerability of the handheld, light-weight Easy Vax™,” said Samer El-Kamary, M.D., M.P.H., assistant professor of epidemiology and pediatrics at the University of Maryland School of Medicine and an associate member of its Center for Vaccine Development.