VBI Vaccines Announces Completion of Enrollment in PROTECT Phase 3 Clinical Study for Sci-B-Vac® Hepatitis B Vaccine
April 19 2018 - 8:00AM
VBI Vaccines Inc. (NASDAQ:VBIV) (“VBI”) today announced the
completion of enrollment with the last patient receiving the first
dose in the ongoing PROTECT Phase 3 study of Sci-B-Vac®, the
company’s third-generation hepatitis B vaccine. More than
1,600 adults have now been enrolled in the PROTECT study at 27
sites across the U.S., Europe, and Canada.
The PROTECT study is one of two ongoing global studies that form
the Phase 3 program for Sci-B-Vac®. It is designed to
evaluate the safety and immunogenicity of Sci-B-Vac® compared with
the control vaccine, Engerix-B®, in support of future regulatory
filings in the U.S., Europe, and Canada.
“The completion of enrollment in the PROTECT study is a
significant milestone in this pivotal Phase III program,” said Jeff
Baxter, President and CEO of VBI. “Data from this
head-to-head immunogenicity study will inform the positioning and
differentiation of Sci-B-Vac®. We look forward to reporting
the topline data and remain dedicated to advancing Sci-B-Vac®
through phase 3 development as quickly as possible.”
Topline data from the PROTECT study are expected mid-year
2019.
About PROTECT – Safety and Immunogenicity
Study
PROTECT is a double-blind, two-arm, randomized, controlled
study. More than 1,600 adult subjects, 18 years of age and older,
have been randomized in a 1:1 ratio to receive either a three-dose
course of Sci-B-Vac® 10μg or a three-dose course of the control
vaccine, Engerix-B® 20μg. Under the planned dosing schedule,
subjects will be vaccinated at months zero, one, and six.
Enrollment has been stratified by age group.
The co-primary objectives of the study are:
- To demonstrate non-inferiority of the seroprotection rate
induced by Sci-B-Vac® vs. Engerix-B® four weeks after the third
vaccination in adults age 18 and older.
- To demonstrate superiority of the seroprotection rate induced
by Sci-B-Vac® vs. Engerix-B® four weeks after the third vaccination
in adults older than 45 years of age.
The study also includes multiple secondary objectives to
evaluate the speed to seroprotection, including assessment after
two doses of Sci-B-Vac® vs. three doses of Engerix-B®, and the
overall safety and tolerability of Sci-B-Vac® vs. Engerix-B®.
About Sci-B-Vac®
Sci-B-Vac® is a licensed third-generation hepatitis B vaccine
that has demonstrated safety and efficacy in over 500,000 patients.
Sci-B-Vac is currently approved for use in Israel and in 14 other
countries. In contrast to second-generation hepatitis B vaccines,
which contain only one surface antigen (the S antigen), Sci-B-Vac
contains the S antigen and the pre-S1 and pre-S2 surface antigens.
The composition of Sci-B-Vac may prove more immunogenic in subjects
that currently do not respond optimally to second-generation
vaccines.
To learn more about Sci-B-Vac®, visit:
https://www.vbivaccines.com/sci-b-vac/
About VBI Vaccines Inc.
VBI Vaccines Inc. (“VBI”) is a commercial-stage
biopharmaceutical company developing a next generation of vaccines
to address unmet needs in infectious disease and immuno-oncology.
VBI’s first marketed product is Sci-B-Vac®, a hepatitis B (HBV)
vaccine that mimics all three viral surface antigens of the
hepatitis B virus; Sci-B-Vac is approved for use in Israel and 14
other countries. VBI’s eVLP Platform technology allows for the
development of enveloped virus-like particle (eVLP) vaccines that
closely mimic the target virus to elicit a potent immune response.
VBI is advancing a pipeline of eVLP vaccines, with lead programs in
cytomegalovirus (CMV) and glioblastoma multiforme (GBM). VBI is
also advancing its LPV™ Thermostability Platform, a proprietary
formulation and process that enables vaccines and biologics to
preserve stability, potency, and safety. VBI is headquartered in
Cambridge, MA with research operations in Ottawa, Canada and
research and manufacturing facilities in Rehovot, Israel.
- Website Home: http://www.vbivaccines.com/
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VBI Contact
Nicole Anderson, Communications ExecutivePhone: (617) 830-3031
x124Email: info@vbivaccines.com
VBI Investor Contact
Nell BeattieChief Business OfficerEmail: IR@vbivaccines.com
VBI Media Contact
Justin JacksonBurns McClellan Life Sciences Communications
Phone: (212) 213-0006Email: jjackson@burnsmc.com
Cautionary Statement on Forward-looking
Information
Certain statements in this press release that are
forward-looking and not statements of historical fact are
forward-looking statements within the meaning of the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995
and are forward-looking information within the meaning of Canadian
securities laws (collectively, “forward-looking statements”). The
company cautions that such statements involve risks and
uncertainties that may materially affect the company's results of
operations. Such forward-looking statements are based on the
beliefs of management as well as assumptions made by and
information currently available to management. Actual results could
differ materially from those contemplated by the forward-looking
statements as a result of certain factors, including but not
limited to the ability to establish that potential products are
efficacious or safe in preclinical or clinical trials; the ability
to establish or maintain collaborations on the development of
therapeutic candidates; the ability to obtain appropriate or
necessary governmental approvals to market potential products; the
ability to obtain future funding for developmental products and
working capital and to obtain such funding on commercially
reasonable terms; the company's ability to manufacture product
candidates on a commercial scale or in collaborations with third
parties; changes in the size and nature of competitors; the ability
to retain key executives and scientists; and the ability to secure
and enforce legal rights related to the company's products. A
discussion of these and other factors, including risks and
uncertainties with respect to the company, is set forth in the
Company's filings with the Securities and Exchange Commission and
the Canadian securities authorities, including its Annual Report on
Form 10-K filed with the Securities and Exchange Commission on
February 26, 2018, and filed with the Canadian security authorities
at sedar.com on February 26, 2018, as may be supplemented or
amended by the Company's Quarterly Reports on Form 10-Q. Given
these risks, uncertainties and factors, you are cautioned not to
place undue reliance on such forward-looking statements, which are
qualified in their entirety by this cautionary statement. All such
forward-looking statements made herein are based on our current
expectations and we undertake no duty or obligation to update or
revise any forward-looking statements for any reason, except as
required by law.
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