BioSante releases positive data on vaccine enhancer CaP

By Elaine Rigoli

Tampa, Fla., May 8 - BioSante Pharmaceuticals, Inc. released positive results of several preclinical studies, demonstrating that its calcium phosphate (CaP) nanoparticle-based vaccine adjuvant, BioVant, may serve as an adjuvant for the development of an effective flu virus vaccine, including the potentially pandemic H5N1 bird flu.

"As the potential danger of a bird flu pandemic rises, the need for a safe and effective vaccine grows increasingly urgent," president and chief executive officer Stephen M. Simes said in a news release.

"A vaccine with an adjuvant included may allow for better efficacy and lower doses per vaccination, which may help prevent shortages. More importantly, addition of an adjuvant may enable more people to produce an immune response that would offer protection from disease."

The BioVant-adjuvanted flu vaccine preclinical studies used the M1 protein, H3N1 and H5N1 (known as bird flu) virus strains. These vaccine candidates were delivered via injection and non-injection (needle-free). The cumulative results confirm that:

• BioVant can enhance flu-specific immunity;

• BioVant - M1 Protein Flu vaccine protected animals from live H1N1 flu virus;

• BioVant elicits high titers of bird flu-specific antibodies (1:6,400);

• BioVant may be a good mucosal adjuvant for the H5N1 vaccine.

Lincolnshire, Ill.-based BioSante is developing its CaP for novel vaccines, including avian flu and biodefense vaccines for toxins such as anthrax and ricin, and drug-delivery systems.

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