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news.US-based specialty vaccine firm PaxVax has reported positive results from a Phase III safety and lot-to-lot consistency trial of PXVX0200, its single-dose oral cholera vaccine candidate.
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PXVX0200 uses the same attenuated vaccine strain (CVD 103-HgR) previously approved and marketed in several countries under the brand name Orochol.
The company plans to submit a Biologics License Application (BLA) for PXVX0200, under the brand name Vaxchora, to the US Food and Drug Administration (FDA) in mid-2015.
The Phase III trial evaluated the immunogenicity and safety of three consecutive production lots of the PXVX0200 vaccine candidate, which induced immunological responses across the trial subjects that met the pre-specified immunological endpoint for consistency of manufacture.
PaxVax chief executive officer Kenneth Kelley said: "US 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.
"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."
The lots of vaccine used for the trial were formulated by the company in its San Diego Good Manufacturing Practice (GMP)-certified facility.
The company said that the result of this trial is the last major clinical milestone prior to submission of market applications in the US, the EU, Canada and Australia.