SUNDAY, SEPTEMBER 25, 2016

PaxVax will seek FDA approval of single-dose cholera vaccine

PaxVax, Inc. announced positive results today from a Phase 3 trial of its oral cholera vaccine candidate PXVX0200.

The trial evaluated the immunogenicity and safety of three lots of the PXVX0200 vaccine candidates. All of the lots induced immunological responses across the approximately 3,000 people enrolled as trial subjects in the United States and Australia.

PaxVax will soon submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration for the vaccine, which will have the brand name Vaxchora.

“U.S. travelers currently have limited options to protect themselves against cholera, and we are pleased with the progress we are making in bringing an effective single-dose cholera vaccine to travelers and potentially those suffering endemic disease in developing countries in the future,” PaxVax CEO Kenneth Kelley said. “These favorable lot-to-lot consistency results validate our manufacturing capabilities and provide us with the last critical data required to support our BLA submission for Vaxchora.”

Cholera is an acute intestinal infection that is usually transmitted via contaminated food and water. The World Health Organization said it affects 3 to 5 millon people each year, and results in 100,000 to 120,000 deaths annually.

A vaccine for cholera is unavailable in the United States and is only available in Europe as a two-dose regimen. If licensed by the FDA, Vaxchora would be the first single-dose vaccine.

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