* Key Step Towards Practical Pandemic Preparedness
* Conducted To FDA-Reviewed Protocol
* Clears Process For Phase I Clinical Later In Year
* Influenza Antigen Used Was Non-Egg-Based
* True Powder Formulation Using GelSite(R) Polymer
IRVING, Texas, Jan. 15 /PRNewswire-FirstCall/ -- Carrington Laboratories, Inc. (OTC Bulletin Board: CARN) today announced that its wholly owned DelSite Biotechnologies, Inc. subsidiary has successfully completed preclinical toxicology studies of its GelVac(TM) nasal powder influenza vaccine under FDA-reviewed protocols. 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 this year. 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' homes and self-administered in the event of a pandemic outbreak of avian bird flu.
The toxicology studies were conducted at Charles River Laboratories, Preclinical Services, Wilmington, MA, a contract research organization well known for its work in preclinical studies of viral antigens. 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.
Separately, DelSite successfully completed its second pre-IND meeting
with the FDA last November, which was held at the request of the FDA to
discuss and clarify protocols related to the use of the H5N1 antigen.
Previously, a Phase I human safety study on the GelVac(TM) platform
(without an antigen) showed the delivery platform was safe
|SOURCE Carrington Laboratories, Inc.|
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