News | January 15, 2008

Nasal Powder Bird Flu Influenza Vaccine Passes Preclinical Toxicology Studies

January 16, 2008 - Carrington Laboratories Inc. today said its wholly owned DelSite Biotechnologies Inc. subsidiary successfully completed preclinical toxicology studies of its GelVac nasal powder influenza vaccine under FDA-reviewed protocols.

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.

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 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 platform (without an antigen) showed the delivery platform was safe and well tolerated. The GelVac nasal powder formulation with the H5N1 vaccine antigen is planned to enter a Phase I study in 2008.

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