Carrington says 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 (bird flu) vaccine in late 2007.
The toxicology studies are being conducted at a contract research organization, using study protocols that have been reviewed by FDA. The GLP vaccine test articles were prepared and shipped to the study site according to the schedule established after receipt of the H5N1 antigen.
GelVac nasal powder platform is a novel, in-situ gelling powder formulation based on its GelSite polymer technologies. A Phase I human safety study on this platform (without an antigen) has been completed and found the platform safe and well tolerated.
DelSite says preclinical studies with influenza antigen have shown that the nasal powder influenza vaccine is not only effective, but also provides distinct logistic advantages including room temperature stability and refrigeration-free distribution that are critical to pandemic preparedness.
The company anticipates the filing of IND paperwork before the end of 2007.
The development of GelVac nasal powder bird flu vaccine is partially funded by two grants from NIAID (national institute of allergy and infectious diseases) of NIH (national institute of health), under the department of health and human services.