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VBI Vaccines announced the US Food and Drug Administration accepted the company’s application for Sci-B-Vac hepatitis b vaccine as an investigational new drug for a phase 3 clinical program.
VBI Vaccines (NASDAQ:VBIV; TSX:VBV) announced the US Food and Drug Administration (FDA) accepted the company’s application for Sci-B-Vac hepatitis b vaccine as an investigational new drug (IND) for a phase 3 clinical program.
As quoted in the press release:
The company had previously received a No Objection Letter (NOL) from Health Canada in response to its Clinical Trial Application (CTA) as well. Acceptance of the IND and CTA enable the company to initiate the Phase 3 clinical study in both the U.S. and Canada.
“The receipt of formal acceptance of our clinical program from both the FDA and Health Canada marks a significant milestone as we move forward to initiating enrollment later this year in this Phase 3 pivotal program,” said Jeff Baxter, President and CEO of VBI. “This program is expected to be conducted at approximately 40 sites across the U.S., Canada and Europe.”
VBI previously announced the design of its 4,800-subject clinical program which will consist of two concurrent, 15-month Phase 3 studies – a safety and immunogenicity study (PROTECT) and a lot-to-lot consistency study (CONSTANT).
Click here to read the full press release.
Source: www.marketwired.com
