Vical Announces Initiation of a Phase 2 Trial of Its HSV-2 Therapeutic DNA Vaccine for Genital Herpes
September 26 2016 - 6:30AM
Vical Incorporated (Nasdaq:VICL) announced today the initiation of
a Phase 2 trial of the company’s Vaxfectin™-formulated, bivalent,
therapeutic DNA vaccine for herpes simplex virus type 2 (HSV-2)
infection. The randomized, double-blind, placebo-controlled trial
will evaluate the efficacy and safety of the vaccine in
approximately 225 healthy adults aged 18 to 50 years with
symptomatic genital HSV-2 infection at up to 15 U.S. clinical
sites.
“About one in six persons between the ages of 14
and 49 is infected with HSV-2. Given the substantial unmet need for
HSV-2 treatments and the lack of new therapeutic breakthroughs for
HSV-2 in decades, we look forward to further exploring the
potential of Vical’s bivalent vaccine,” said Anna Wald, MD, MPH,
Professor, Department of Medicine, Epidemiology and Laboratory
Medicine at the University of Washington and Lead
Investigator of the trial. “If we can demonstrate that this
vaccine controls the frequency of HSV-2 recurrences, it may offer
an exciting new treatment modality for physicians that would free
patients from daily, antiviral drug usage.”
After a 4-dose vaccination series, subjects will
be evaluated for recurrences over a 12-month period. Following
extensive discussions with the FDA, Vical has selected recurrence
rate as the primary endpoint for the study. “Based on
discussions with our clinical experts, we have concluded that
recurrence rate is one of the most clinically meaningful endpoints
for patients with genital herpes,” said Mammen P. “Anza” Mammen,
Jr., M.D., Vice President, Clinical Vaccines at Vical. “The
endpoint of ‘annualized recurrence rate’ provides information on
both the number and spacing of recurrences over time which we
believe makes it more informative in this chronic disease setting
than the endpoints of ‘time to first recurrence’ and ‘proportion of
subjects recurrence-free’, both of which only measure the
recurrence of singular events.”
The Phase 2 trial has been designed based on
Phase 1/2 trial results presented at the 2016 American Society for
Microbiology (ASM/ICAAC) Microbe Meeting in June that revealed a
statistically significant reduction (-57%, p = 0.009) in lesion
rate compared to baseline in the bivalent vaccine arm at 9 months,
along with favorable trends in recurrence rate, time to first
recurrence, and proportion of subjects who were recurrence-free. In
addition, the bivalent vaccine produced a statistically significant
increase in antigen-specific interferon gamma producing T cells. No
serious adverse events, Grade 4 adverse events, or adverse events
of special interest related to vaccinations were observed during
the study period.
HSV-2 is a sexually transmitted virus which is
the leading cause of recurrent genital herpes. HSV-2 infections are
persistent and 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.
The Company’s cash burn projection remains
unchanged for 2016 at between $8 million and $11 million,
which includes the cash burn associated with the initiation of the
HSV-2 Phase 2 clinical program.
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
anticipated developments in clinical programs, including the plans,
timing of initiation, enrollment and announcement of data for
clinical trials and the potential benefits of Vical’s product
candidates. Risks and uncertainties include whether Vical or others
will continue development of Vical’s HSV-2 vaccine or any other
independent or collaborative programs; whether Vical or its
collaboration partners will be able to obtain regulatory allowances
or guidance necessary to proceed with proposed clinical trials or
implement anticipated clinical trial designs; whether Vical’s Phase
2 HSV-2 vaccine trial will be completed on the timelines Vical
currently expects or conducted in the manner Vical currently
expects; whether any product candidates will be shown to be safe
and efficacious in clinical trials; whether Vical will have access
to sufficient capital to fund its planned development activities;
whether Vical will seek or gain approval to market 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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