Vical Announces Completion of the Phase 3 ASP0113 CMV Vaccine Trial
October 10 2017 - 6:30AM
Vical Incorporated (Nasdaq:VICL) announced today that the last
patient completed their final assessment during the one year
follow-up period in the multinational Phase 3 registration trial of
ASP0113 in hematopoietic cell transplant (HCT) recipients. The
trial completed enrollment in September 2016 with a total of 515
subjects. The primary endpoint of the trial is a composite of
overall mortality and cytomegalovirus (CMV) end-organ disease which
will be assessed one year after transplantation. Astellas Pharma
Inc. (“Astellas”) expects top-line data to be available in the
first quarter of 2018.
Vicals development partner Astellas conducted
the trial and has an exclusive worldwide license from Vical to
develop and commercialize ASP0113. Vical developed ASP0113 through
Phase 2 and continues to provide Astellas with development,
regulatory and manufacturing support for the program.
“This is yet another exciting milestone for
ASP0113, the first CMV vaccine to complete a pivotal Phase 3
trial,” said Vijay Samant, Vical’s Chief Executive Officer. “This
has been a highly productive partnership with Astellas and both
companies look forward to sharing the results of this study with
the HCT community in the first quarter of 2018. Furthermore, we
look forward to potentially commercializing this first-in-class,
vaccine-based preventative therapy for CMV in HCT recipients.”
The Phase 3 trial enrolled patients at over 70
clinical trial sites in 11 countries throughout North America,
Europe, Asia, and Australia and was designed to support full
approval of ASP0113 for the prevention of CMV reactivation in CMV
seropositive HCT recipients. Randomization of HCT recipients in
this double-blind, placebo-controlled trial was stratified by
donor-recipient relatedness and donor CMV serostatus. The trial’s
primary endpoint is a composite of overall mortality and CMV
end-organ disease, and secondary endpoints include time to first
CMV viremia and time to CMV-specific antiviral therapy.
About CMV CMV is a herpes
virus that infects more than half of all adults in the United
States by age 50, and is even more widespread in developing
countries. A healthy immune system typically protects an infected
person against CMV disease, but does not prevent or clear latent
infection. Individuals whose immune systems are not fully
functional are at high risk of CMV reactivation, potentially
leading to severe illness or death. Those at greatest risk include
HCT and solid organ transplant recipients, as well as infants born
to mothers who first become infected during pregnancy.
About ASP0113ASP0113 is an
investigational vaccine candidate designed to prevent CMV disease
and associated complications in CMV seropositive HCT recipients.
ASP0113 is a bivalent DNA vaccine encoding CMV phosphoprotein 65
and glycoprotein B antigens for induction of both cellular and
humoral immune responses, formulated with a proprietary
poloxamer-based delivery system. ASP0113 was initially developed by
Vical and has been partnered with Astellas for further development
and commercialization. ASP0113 has received Orphan Drug Designation
in the U.S. and Europe.
About VicalVical develops
biopharmaceutical products for the prevention and treatment of
chronic or life-threatening infectious diseases, based on its
patented DNA delivery technologies and other therapeutic
approaches. Additional information on Vical is available at
www.vical.com.
Forward-Looking StatementsThis
press release contains forward-looking statements subject to risks
and uncertainties that could cause actual results to differ
materially from those projected. Forward-looking statements include
statements about the potential uses and benefits of ASP0113, the
parameters of the Phase 3 trial and timing regarding results from
the Phase 3 trial. Risks and uncertainties include whether Vical's
technology will be successfully applied; whether ASP0113 or
any product candidates will be shown to be safe and effective in
clinical trials; whether the Phase 3 trial of ASP0113 will proceed
on Astellas’ expected timing or be completed, and if so, whether
results will support further development or commercialization;
whether ASP0113 will be successfully developed and commercialized;
whether Vical or its collaborative partners will seek or gain
approval to market any product candidates; whether Vical or its
collaborative partners will succeed in marketing any product
candidates; and additional risks set forth in the company's filings
with the Securities and Exchange Commission. These forward-looking
statements represent the company's judgment as of the date of this
release. The company disclaims, however, any intent or obligation
to update these forward-looking statements.
Contact:
Andrew Hopkins
(858) 646-1127
Website: www.vical.com
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