BIOSANTE ANNOUNCES SAFETY OF BIRD FLU VACCINE ADJUVANT

BioSante Pharmaceuticals has announced positive results from a dose-ranging preclinical study demonstrating that its calcium phosphate nanoparticle-based vaccine adjuvant, BioVant, may serve as a vaccine adjuvant for the development of an effective vaccine against H5N1 avian flu.

The study's objective was to determine the optimal formulation of BioVant with a very low dose of H5N1 antigen. At the start of the 16-week trial, mice received either the H5N1 antigen alone or in one of several formulations with BioVant. A booster immunization was administered after two and 10 weeks. Results showed that the administration of a BioVant/H5N1 formulation stimulated a significantly higher production of titers of H5N1-specific antibodies than H5N1 alone. Further, the anti-influenza antibody levels continued to increase over the entire study period, suggesting good duration of immunity.

"A vaccine with an adjuvant included may allow for better efficacy and lower doses per vaccination, which may help to prevent shortages," Stephen Simes, president and CEO of BioSante, said. "We hope to move into additional pre-clinical trials and attract a vaccine manufacturer to use BioVant in a new flu vaccine."

BioVant is composed of specially formulated calcium phosphate. In multiple studies, BioVant has been shown to be safe and cause minimal dose-dependent inflammation at the injection site. As opposed to the conventional vaccine adjuvant alum, BioVant induces insignificant immunoglobulin E and higher serum IgG2a levels, a reaction that is widely recognized as a precursor to a Th1 CD4 T-cell response, according to the company. Th1-type responses are known to promote immunity against intracellular pathogens.