PXVX 0200 vaccine meets goals in Phase III trial for Cholera-PaxVax

PaxVax has announced positive results from a Phase III safety and lot-to-lot consistency trial of its single-dose oral Cholera vaccine candidate, PXVX 0200, which utilizes the same attenuated vaccine strain (CVD 103-HgR) previously approved and marketed in several countries under the brand name Orochol. PaxVax intends to submit a Biologics License Application (BLA) for this product, under the brand name Vaxchora, to the FDA in mid-2015. The Phase III trial evaluated the immunogenicity and safety of three consecutive production lots of the PXVX 0200 vaccine candidate.

The three production lots induced immunological responses across the clinical trial subjects that met the pre-specified immunological endpoint for consistency of manufacture. The lots of vaccine used for the trial were formulated by PaxVax in its San Diego Good Manufacturing Practice (GMP)-certified facility. The results of this trial are the last major clinical milestone prior to submission of market applications in the U.S., the European Union, Canada, and Australia.