Cytomegalovirus
( #CMV) News; VBI Vaccines (Nasdaq: $VBIV) (TSX: $VBV) Reports on its
Congenital CMV Phase I Clinical Study
Congenital
#CMV infection is a leading cause of birth defects, affecting more live
births than #Downsyndrome or #fetalalcoholsyndrome
CAMBRIDGE,
MA - May 3, 2017 (Investorideas.com Newswire) Breaking Vaccine
News: VBI Vaccines Inc. (Nasdaq:
VBIV) (TSX: VBV) ("VBI")
provides an update on its cytomegalovirus ("CMV") Phase I clinical
study, which is assessing the safety and tolerability of VBI's vaccine
candidate to prevent congenital CMV infection. Congenital CMV infection is a
leading cause of birth defects, affecting more live births than Down syndrome
or fetal alcohol syndrome, making it a key public health priority.
Upon
review of all safety data up to one month after second immunizations in VBI's
prophylactic CMV Phase I clinical study, the Data and Safety Monitoring Board
("DSMB") unanimously recommended the continuation of the study
without modification. No safety signals have been detected, suggesting VBI's
CMV vaccine candidate is safe and well-tolerated.
Additionally,
all participants in the study have now successfully received the third and
final immunization in the series. Further vaccine immunogenicity and safety
follow-up are ongoing.
An
interim safety and immunogenicity report, based on blood samples collected from
participants one month post-second vaccination, is expected mid-year
2017.
About the Phase I
Clinical Study Design
The
Phase I study is designed to assess the safety and tolerability of VBI’s CMV
vaccine candidate in approximately 125 healthy CMV-negative adults. The study
will also determine the vaccine immunogenicity by measuring levels of vaccine-induced
CMV neutralizing antibodies, which may prevent CMV infection.
Additional
information, including a detailed description of the study design, eligibility
criteria, and investigator sites, is available at ClinicalTrials.gov using identifier
NCT02826798.
About the Data and
Safety Monitoring Board
The
DSMB was formed with key opinion leaders, a statistician, and experts in safety
in clinical studies of this nature. The board is an arms-length committee that
monitors the clinical study to assess safety data at various time points during
the clinical study, and to recommend to VBI whether to continue, modify, or
stop the study.
About CMV
CMV can cause
serious disease in newborns when a mother is infected during pregnancy. Each
year, approximately 5,000 U.S. infants will develop permanent problems due to
CMV, which can include deafness, blindness, and mental retardation. CMV
affects more live births than Down syndrome or fetal alcohol syndrome, making
it a key public health priority and a strong candidate for recommended
universal vaccination and reimbursement.
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 enables the development of enveloped (“e”) virus-like particle
(“VLP”) 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 allows 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.
VBI Contact
Perri
Maduri, Communications Executive
Phone:
(617) 830-3031
VBI Investor
Contact
Nell
Beattie
Director,
Corporate Development and Investor Relations
Cautionary Statement
on Forward-looking Information
Certain statements
in this news release contain forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995 or forward-looking
information under applicable Canadian securities legislation (collectively,
“forward-looking statements”) that may not be based on historical fact, but
instead relate to future events, including without limitation statements
containing the words “may”, “plan”, “will”, “suggesting”, “expected”, and
similar expressions. All statements other than statements of historical fact
included in this release are forward-looking statements, including statements
regarding: plans for Phase III clinical studies, the provision of additional
information about clinical studies, the safety and tolerability of the
congenital CMV vaccine candidate, the provision of an interim safety and
immunogenicity report, and the potential effects of Sci-B-Vac™.
Such forward-looking
statements are based on a number of assumptions, including assumptions
regarding the successful development and/or commercialization of the company’s
products, including the receipt of necessary regulatory approvals; general
economic conditions; competitive conditions; and changes in applicable laws,
rules and regulations.
Although management
believes that the assumptions made and expectations represented by such
statements are reasonable, there can be no assurance that a forward-looking
statement contained herein will prove to be accurate. Actual results and developments
may differ materially from those expressed or implied by the forward-looking
statements contained herein and even if such actual results and developments
are realized or substantially realized, there can be no assurance that they
will have the expected consequences or effects. Factors which could cause
actual results to differ materially from current expectations include: the
failure to successfully develop or commercialize the company’s products;
adverse changes in general economic conditions or applicable laws, rules and
regulations; and other factors detailed from time to time in the company’s
reports filed with the U.S Securities and Exchange Commission and the Canadian
Securities Commissions.
Given these risks,
uncertainties and factors, you are cautioned not to place undue reliance on
such forward-looking statements and information, which are qualified in their
entirety by this cautionary statement. All forward-looking statements and
information made herein are based on the company’s current expectations, and
the company undertakes no obligation to revise or update such forward-looking
statements and information to reflect subsequent events or circumstances,
except as required by law.
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