The research was conducted in collaboration with researchers from the Johns Hopkins Bloomberg School of Public Health and the University of Texas School of Public Health.
Iomai plans to begin a Phase 3 program for the needle-free vaccine patch vaccine in 2008.
"We are moving this product ahead as quickly as possible," said Chief Executive Officer Stanley C. Erck. "This is a pressing, unmet medical need. Travelers' diarrhea is the most common travel ailment in the world, yet there are no effective vaccines available for the condition. A recently completed market study suggests that there is a $750 million market for effective protection against travelers' diarrhea, an opportunity that we are well-positioned to target."
About the Phase 2 Trek Study
The Trek Study followed 170 travelers to Mexico and Guatemala. Each volunteer received either two doses of the Iomai vaccine patch or a placebo, 2 to 3 weeks apart, with the last dose administered a week before travel. Travelers kept detailed diaries and received in-country checkups. The study met its primary endpoints, which were designed to evaluate the safety of the vaccine and the incidence of enterotoxigenic E. coli (ETEC) bacteria -- the most common cause of travelers' diarrhea. No vaccine-related serious adverse events were reported.
Of the few vaccinated patients who were sickened, the diarrhea lasted
only half a day on average, while those in the placebo group endured two
days of illness and more than twice as many loose stools. Although not
statistically significant, the fre
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