VaxGen presents new smallpox vaccine data at biodefense research meeting

By Lisa Kerner

Erie, Pa., Feb. 15 - VaxGen, Inc. announced new non-clinical and clinical data from studies of its attenuated smallpox vaccine candidate, LC16m8, which indicate that the vaccine may represent a viable replacement for the conventional smallpox vaccine currently in the U.S. Strategic National Stockpile.

The data are being presented at this week's American Society of Microbiology Biodefense Research Meeting in Washington, D.C., according to a company news release.

VaxGen said it is developing LC16m8 for use in the United States and elsewhere in partnership with the Chemo-Sero-Therapeutic Research Institute of Kumamoto, Japan, the licensed manufacturer of LC16m8.

LC16m8 is a cloned virus vaccine produced in cell culture that has been shown to be less neurovirulent than unattenuated strains of vaccinia vaccines in preclinical models, the release stated.

"We are very pleased that LC16m8 was 100% protective in preclinical poxvirus challenge models. In our phase 2 clinical trial comparing a single dose of LC16m8 to a single dose of the nonattenuated vaccine, Dryvax, in 153 vaccinia-naive volunteers, LC16m8 appears to have an excellent safety profile and to be well-tolerated," chief medical officer Marc Gurwith said in the release.

The phase 2 study also demonstrated that 100% of LC16m8 recipients seroconverted and developed a lesion showing the vaccination is successful, compared to 86% among the Dryvax subjects, officials said.

VaxGen is a biopharmaceutical company which develops, manufactures and commercializes biologic products for the prevention and treatment of human infectious diseases, including anthrax, smallpox and Meningitis B. The company is located in Brisbane, Calif.

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