Vical Completes Target Enrollment in Its Phase 2 Therapeutic HSV-2 Vaccine Trial
April 19 2017 - 6:30AM
Vical Incorporated (Nasdaq:VICL) announced today that it has
completed the target enrollment of 225 subjects in a Phase 2 trial
of its therapeutic bivalent vaccine for herpes simplex virus type 2
(HSV-2), the leading cause of recurrent genital herpes.
The randomized, double-blind, placebo-controlled
trial is designed to evaluate the efficacy and safety of the
vaccine in healthy adults aged 18 to 50 years with symptomatic
genital HSV-2 infection and is being conducted at 15 U.S. clinical
sites. Subjects are evaluated for lesion recurrences over a
12-month period following a 4-dose vaccination series. The study is
powered to show a reduction in annualized lesion recurrence rate,
an endpoint which is clinically meaningful in this chronic disease
setting because it provides information on the number of
recurrences over time.
“A therapeutic vaccine is an important and
promising new approach for reducing genital lesion recurrences
because of its potential ability to boost immunity against HSV-2,”
said Dr. John Kriesel, Associate Professor and infectious disease
specialist at the University of Utah School of Medicine and one of
the investigators in the Phase 2 trial. “Genital herpes afflicts
one in six people in the United States and can be emotionally
debilitating. A therapeutic vaccine would give patients a new
treatment for this chronic disease.”
“We are pleased with the outstanding support we
have received from our investigators and site staff, as the
completion of the target enrollment of this Phase 2 trial
represents an important milestone for this program,” said Dr.
Mammen “Anza” Mammen, Vical’s Vice President, Clinical Vaccines.
“We continue to follow these subjects and anticipate release of
top-line efficacy results during the second quarter of 2018.”
HSV-2 is a sexually transmitted virus that
causes a persistent infection that can result in painful genital
lesions, as well as intermittent virus shedding placing sexual
partners at risk of infection. Infection with HSV-2 also
significantly increases the risk of acquiring the HIV-1 virus from
HIV-infected sexual partners. There is no FDA approved vaccine for
HSV-2. Vical’s investigational therapeutic bivalent vaccine encodes
two full-length, HSV-2 antigens, glycoprotein D and VP11/12
tegument protein (also referred to as UL46) and is formulated with
our patented adjuvant Vaxfectin®.
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.
This 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 Vical's therapeutic HSV-2 vaccine, the
parameters of the Phase 2 trial and timing regarding results from
the Phase 2 trial. Risks and uncertainties include whether Vical's
technology will be successfully applied; whether preclinical
results will be predictive of results in human clinical testing;
whether the HSV-2 vaccine or any product candidates will be shown
to be safe and effective in clinical trials; whether the Phase 2
trial of Vical’s HSV-2 vaccine will proceed on Vical’s expected
timing or be completed, and if so, whether results will support
further development or commercialization; whether Vical will
successfully develop and commercialize its HSV-2 vaccine; 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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