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news.The US Food and Drug Administration (FDA) has accepted PaxVax's investigational new drug (IND) application of its single-dose oral cholera vaccine.
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PXVX-0200 is a live attenuated vaccine against cholera, which was previously approved and marketed in six countries under the brand name Orochol.
The company expects to begin Phase III trials later in 2012.
The company has partnered with SynCo Bio Partners, located in Netherlands, to manufacture the initial material for the cholera vaccine for clinical trials.
PaxVax chief executive officer Kenneth Kelley said the company expects cholera vaccine will be the first vaccine for cholera available in the US, and the only one-dose oral vaccine in the world.
"Further, given that cholera is classified as a neglected tropical disease by the FDA, this product should qualify us for a priority review voucher," Kelley added.