FRIDAY, JUNE 15, 2018

PaxVax initiates Phase III trial for oral cholera vaccine

PaxVax, Inc., a Menlo Park, California-based vaccine developer, announced on Friday that it initiated the Phase III clinical trial program for its PXVX0200 single-dose oral cholera vaccine candidate.

The company will enroll approximately 3,000 participants in the cholera challenge safety and immunogenicity studies. In the cholera challenge studies, volunteers will be vaccinated and then exposed or challenged to the Vibrio cholerae bacterium. Other trials will confirm vaccine safety in a larger population, measure immunogenicity and demonstrate lot-to-lot consistency of different batches of vaccine.

"Cholera continues to infect areas around the world that suffer from poor sanitation, poverty and poor access to safe drinking water, particularly parts of the world like Haiti and South Asia that are recovering from recent natural disasters," Mitch Cohen, the vice chair of pediatrics for clinical affairs at Cincinnati Children's Hospital Medical Center, said. "For travelers visiting endemic areas of the world where significant risk of contracting cholera exists, we are eager to start these clinical trials which will determine if an oral single dose of PXVX0200 provides protection against cholera after vaccination."

A Phase I trial of PXVX0200 found the vaccine was highly immunogenic and well tolerated. Overall seroconversion to vibriocidal antibody occurred in 89 percent of vaccines by day 14 and onset of immune response was rapid with 80 percent of subjects.

"We are proud and excited to develop the first potential oral single-dose and fast-acting cholera vaccine for travelers in the U.S. and around the world," Ken Kelley, the CEO of PaxVax, said. "PXVX0200 is our lead vaccine candidate. Pending the successful outcome of these trials, we hope to file a biologics license application and begin to establish our traveler's vaccine portfolio."

Cholera is an acute intestinal infection caused by food or water contaminated by Vibrio cholerae bacteria. According to the World Health Organization, cholera causes approximately three to five million cases annually and 100,000 to 130,000 deaths per year worldwide.