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news.Carrington Laboratories has announced that its wholly owned subsidiary, DelSite Biotechnologies, has successfully completed preclinical toxicology studies of GelVac nasal powder influenza vaccine under FDA-reviewed protocols.
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After administering one or two doses to test subjects at the highest dose tested, testing results showed the vaccine is safe and nontoxic and thus established the base for moving into the Phase I clinical study of the vaccine in humans subject to normal FDA regulatory procedures.
Successful toxicology studies in two animal models using the H5N1 (bird flu) antigen were required in order to proceed with a planned Phase I clinical trial later in 2008. The bird flu antigen used in these preclinical studies was from a non-egg-based source.
This vaccine candidate is believed to be the only nasal powder vaccine under development that, if approved, could be shipped without refrigeration to peoples’s homes and self-administered in the event of a pandemic outbreak of avian bird flu. The GelVac nasal powder formulation with the H5N1 vaccine antigen is planned to enter a Phase I study in 2008.