VaxGen’s Smallpox Program Highlights
LC16m8 – cold adapted, attenuated, cell culture produced smallpox vaccine
LC16m8 already licensed / stockpiled in Japan
Safety and potency shown in ~ 50,000 children pre-licensure; approximately 100,000 doses administered to date
Developing partnership with Japanese manufacturer, Kaketsuken
- U.S. cGMP compliance program in place
- 1 MM doses manufactured for VaxGen
- U.S. animal efficacy studies Q4 ’03 – 2004
- U.S. clinical trials planned in 2004
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- Commercial supply terms under negotiation