The National Institute of Allergy and Infectious Diseases (NIAID), a branch of the NIH, has granted Vical accelerated access to $2.6 million in funding for further development of Vaxfectin, an avian influenza vaccine being developed under a grant awarded to Vical in September 2005, the company said.
The funds will be used to complete preclinical development of the vaccine and file an investigational new drug application with the FDA, which would allow initiation of a Phase I safety trial in human volunteers. Vical is seeking additional funding to support Phase I human testing, the company said.
In preclinical studies, Vaxfectin has shown complete protection of mice and ferrets against the H5N1 avian influenza virus, as well as the protection of mice against multiple human flu strains. Remaining preclinical work includes safety, toxicology and biodistribution testing of the vaccine in laboratory animals, as well as the manufacturing of human clinical trial supplies in compliance with current good manufacturing practices.