PaxVax announces FDA acceptance of IND for PXVX-0200 cholera vaccine

PaxVax Corporation, developer of innovative and socially responsible oral vaccines against infectious diseases, announced that the U.S. Food and Drug Administration (FDA) has accepted its investigational new drug (IND) application for its single-dose oral cholera vaccine, clearing the way to begin clinical trials. The company intends to begin Phase 3 trials later this year.

Cholera is an acute intestinal infection caused by toxigenic Vibrio cholerae bacterium. Cholera infections are most commonly acquired from ingesting contaminated water or food. Infection causes severe watery diarrhea and even death if not treated promptly. According to the World Health Organization, the global disease burden is estimated to be 3-5 million cases and 100,000-130,000 deaths per year.

PXVX-0200, is a single dose, oral, live, attenuated vaccine against cholera, which was previously approved and marketed in six countries under the brand name "Orochol." Unlike currently available cholera vaccines requiring two doses over the course of weeks before effectiveness, this vaccine's rapid onset of protection in as little as seven days after a single administration makes it ideal for people preparing to travel to areas where cholera is endemic or where it has recently caused an epidemic.

"We expect our cholera vaccine will be the first vaccine for cholera available in the United States, and the only one-dose oral vaccine in the world," said Kenneth Kelley, Chief Executive Officer of PaxVax. "Further, given that cholera is classified as a neglected tropical disease by the FDA, this product should qualify us for a priority review voucher."

The company has partnered with SynCo Bio Partners B.V., a biopharmaceutical GMP Contract Manufacturing Organization with specific expertise in live microbial biotherapeutics located in Amsterdam, The Netherlands, to manufacture the initial material for the cholera vaccine for clinical trials.

Myron M. Levine M.D., Director of the Center for Vaccine Development at the University of Maryland School of Medicine and Albert B. Sabin Gold Medal winner, co-inventor of the vaccine now licensed to PaxVax, and a member of the company's Scientific Advisory Board, commented: "I applaud PaxVax for taking the lead to bring this vaccine back to market. I believe that the practicality of a single-dose oral vaccine will make vaccination logistically simpler and more practical, thereby offering for the future a better tool to control cholera in explosive outbreak situations."





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