The Upcoming Pivotal Phase IIIb Clinical Trial

Vaccinogen plans to launch a randomized pivotal Phase IIIb clinical study of OncoVAX® in Stage II Colon Carcinoma under a Special Protocol Assessment ("SPA") in Q1 2009.

The study is a randomized, controlled trial in Stage II colon carcinoma in which OncoVAX®-treated patients will be compared with untreated control patients. A total of 560 patients will be enrolled at 32 centers in the USA and Europe. The primary endpoint, to be determined 3 years after full enrollment, is disease-free survival (the time from randomization to tumor progression or death due to any cause). The study is powered to detect a 50% reduction in disease progression assuming a 25% recurrence rate in the untreated patients, and will provide 90% power to detect a difference between treatment groups at a 0.005 level of significance. One interim analysis will be conducted 1 year after randomization of the last patient. Based upon discussions with the FDA at the time of the SPA, achievement of a robust p-value at the interim analysis will be sufficient for a BLA submission. Irrespective of the outcome of the interim analysis, all patients will continue to be monitored for recurrences for a median follow-up period of 5 years.