Irving-based Carrington’s subsidiary DelSite initiates toxicology studies of bird flu vaccine

by PegNews wire

IRVING — Carrington Laboratories, Inc. today announced its subsidiary DelSite Biotechnologies, Inc. has initiated the animal toxicology studies of its GelVac nasal powder influenza vaccine, incorporating an H5N1 (bird flu) antigen.

Photo not provided by Carrington

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The toxicology studies are a critical step during the vaccine development and will assess the vaccine safety in animals. Pending successful results of the toxicology studies and discussion with the antigen supplier, DelSite will file an IND for a phase I human safety study of the GelVac nasal powder H5N1 vaccine in late 2007. The toxicology studies are being conducted at a well-known contract research organization, using study protocols that have been reviewed by FDA.

Dr. Carlton Turner, CEO, commented, "With initiation of the animal toxicology studies, we have reached an important milestone for development of this first nasal powder influenza vaccine. Our team has done an outstanding job under a very tight schedule to produce the test materials and complete all logistic tasks for the study initiation. We anticipate the filing of IND paperwork before the end of 2007."

According to Carrington, a phase I human safety study on this platform (without an antigen) has been completed and found to be safe.

Source: Carrington Laboratories