PaxVax Announces Primary Endpoints Met in Phase 3 Cholera Vaccine Trial
Monday, December 8, 2014
PaxVax Inc., a specialty vaccine company focused on travel and biodefense, today announced positive results from a Phase 3 safety and lot-to-lot consistency trial of its single-dose oral cholera vaccine candidate, PXVX0200, 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 U.S. Food and Drug Administration (FDA) in mid-2015.
The Phase 3 trial evaluated the immunogenicity and safety of three consecutive production lots of the PXVX0200 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.
A vaccine for cholera is not currently available in the U.S. for residents who travel abroad to areas where cholera poses a risk, such as Haiti or Central Africa. A cholera vaccine is available in Europe and elsewhere for travelers, but it requires a two-dose regimen. If licensed, oral PXVX0200 would be the first single-dose vaccine against cholera making it more convenient for all travelers, particularly for those traveling on short notice.
Read the full release on www.paxvax.com.