VBI Vaccines To Study Hepatitis B Vaccine in Phase 3 Clinical Program

VBI Vaccines (NASDAQ:VBIV; TSX:VBV) announced a phase 3 clinical program for Sci-B-Vac after positive talks with the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and Health Canada.
As quoted in the press release:

The Phase 3 program will be a global 15-month program and will consist of two concurrent Phase 3 studies – a safety and immunogenicity study (PROTECT) and a lot-to-lot consistency study (CONSTANT), enrolling a total of approximately 4,800 subjects. The Phase 3 program will be conducted at approximately 40 sites across the U.S., Europe, and Canada.
“We consider the outcome of discussions with the FDA, EMA, and Health Canada to be extremely positive,” said Jeff Baxter, president and CEO of VBI. “Sci-B-Vac’s extensive safety and efficacy data package demonstrates safe and effective vaccination of approximately 2,000 subjects in past clinical trials. Because of this track record, we are able to plan a Phase 3 program that will enroll only 4,800 subjects in total and will be only 15-months in duration. We anticipate initiating enrollment in both Phase 3 studies in the second half of 2017.”

Click here to read the full press release.

Source: www.marketwired.com