VBI Vaccines (VBIV) Announces Interim Data from Sci-B-Vac Phase IV in HBV; Strong Seroprotection Rates Noted

November 14, 2016 8:34 AM EST
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VBI Vaccines Inc. (Nasdaq: VBIV) reported interim results from an ongoing Phase IV postmarketing study to evaluate Sci-B-Vac, VBI's licensed third-generation hepatitis B vaccine, in healthy adults.

In its interim analysis, Sci-B-Vac™ was found to be well-tolerated and demonstrated rapid onset of protection against the hepatitis B virus ("HBV"). Seroprotection rates, the percent of patients who produced an antibody response capable of preventing an infection, were as follows:

-- 91.9% of study participants were seroprotected at Month 2, one month
after receiving a second dose of Sci-B-Vac™.
-- 98.8% of participants were seroprotected at Month 3, two months after
receiving a second dose of Sci-B-Vac™, and prior to receiving a third

"These interim results further demonstrate that Sci-B-Vac™ can safely and reliably be used to prevent HBV infection," said Dr. Francisco Diaz-Mitoma, M.D., Ph.D., VBI's Chief Medical Officer. "In addition, the results add to a growing body of evidence that suggests persons receiving Sci-B-Vac™ may develop seroprotection against HBV after receiving just two doses of the vaccine."

"We are also in the process of eliciting feedback on our late-stage clinical development plan from European and North American regulatory bodies," said Jeff Baxter, VBI's President and CEO. "This encouraging data adds to our excitement about the potential of Sci-B-Vac™ to protect against HBV infection in major global markets."

This Phase IV study is for routine quality control purposes and to support the existing licensure of Sci-B-Vac™ in Israel. The study is further designed to validate VBI's new in-house reference standard vaccine for routine quality control purposes, in accordance with the European Pharmacopeia and Israeli Ministry of Health guidelines. The study also seeks to characterize the safety and immunogenicity of Sci-B-Vac™ to further support planned pivotal clinical trials in Europe and North America. VBI will continue to gather and analyze study data, with final results anticipated in the second half of 2017.

Study Design

This Phase IV study is an open label, single arm, single center clinical study now underway in Israel. VBI enrolled 88 healthy, HBV-seronegative males and females between 20 and 40 years of age. Study participants were vaccinated three times with 10 micrograms/ml of Sci-B-Vac™ at zero, one, and six months.

The primary endpoint is seroprotection rate. Successful seroprotection against HBV infection is defined by rate and by an anti-HBV surface antibody (anti-HBs) titer of greater than or equal to 10 mIU/ml following immunization.

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