Vical’s Phase 1/2 Trial Data Presented at ASM 2016 Shows Bivalent Vaccine Imparts Reduction in Genital Herpes Lesions Durab...
June 20 2016 - 11:15AM
Vical Incorporated (Nasdaq:VICL) presented data from the
randomized, double-blind, placebo-controlled Phase 1/2 clinical
trial of its therapeutic genital herpes vaccine in symptomatic
herpes simplex virus type 2 (HSV-2) infected patients in an oral
late-breaker presentation at the American Society for Microbiology
(ASM/ICAAC) Microbe 2016 meeting held in Boston. The slides
presented by Mammen P. "Anza" Mammen, Jr., M.D., Vical’s Vice
President, Clinical Vaccines, will be accessible on Vical’s
website.
The per protocol study analyses included 131
evaluable patients: 54 receiving the monovalent (gD) vaccine, 56
receiving the bivalent vaccine (gD + UL46) and 21 receiving
placebo. Initial top line 3-month data announced in June 2015
showed that neither the monovalent nor the bivalent vaccine met the
primary endpoint of viral shedding rate reduction from baseline.
However, the bivalent vaccine achieved statistically significant
reduction in a prospectively defined secondary endpoint of genital
lesion rate at 3 months versus baseline (-49%, p = 0.031). In the
9-month analysis presented today, the statistically significant
reduction in lesion rate compared to baseline for the bivalent
vaccine was sustained (-57%, p = 0.009). Furthermore, at the
9-month time point, the bivalent vaccine showed a favorable trend
in recurrence rate, time to first recurrence, and proportion of
patients who are recurrence-free. Vical’s vaccines elicited
significant increases in antigen-specific interferon gamma
producing T cells, indicating biologic activity.
An independent Safety Monitoring Board reviewed
all adverse events (AEs) and deemed the vaccines to be safe and
tolerable in this trial. No serious adverse events, Grade 4 AEs, or
AEs of special interest related to vaccinations were observed
during the study period. Grade 3 AEs were reported in 13% of
subjects, the most common of which were fatigue and injection site
pain.
“There remains considerable unmet medical need
in the treatment of genital herpes as there have been no new
therapeutic breakthroughs in the past several decades,” said Dr.
Peter Leone, Professor of Medicine, University of North Carolina
and an external program advisor for Vical. “A therapeutic HSV-2
vaccine could represent a very attractive treatment option to
reduce outbreaks in individuals who suffer chronically from this
disease. The data generated to date with the bivalent HSV-2 vaccine
indicate that it is not only immunogenic, but also provides
evidence for reducing lesion rate, a clinically meaningful endpoint
for patients and physicians. Therefore, the bivalent vaccine
warrants further clinical investigation.”
“We have consulted with multiple experts
involved in treating patients with genital herpes and conducting
clinical trials,” said Vijay Samant, President and Chief Executive
Officer. “Our advisors have encouraged us to evaluate the bivalent
vaccine further in a follow-on study powered to measure a
clinically-relevant endpoint. We have established a continuing
dialogue with the FDA about potential next steps and are currently
finalizing a clinical protocol based on those discussions. We plan
to initiate a Phase 2 trial of the bivalent vaccine during the
second half of 2016. Importantly, we expect to be able to execute
this study using our current resources and under our operational
plan, and maintain our guidance for net cash burn of between $8
million and $11 million during 2016.”
Mr. Samant continued, "We anticipate a number of
additional clinical milestones this year. In our CMV program with
Astellas, we expect that in the third quarter of 2016, enrollment
will be completed in the Phase 3 registration trial in
hematopoietic cell transplant recipients and that top line data
should be available from the Phase 2 trial in kidney transplant
recipients. In addition, we also anticipate completing the Phase 1
trial of our novel antifungal, VL-2397, by year end.”
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
net cash use guidance, as well as 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, ASP0113, VL-2397 or any other
independent or collaborative programs; whether Vical will achieve
levels of revenues and control expenses to meet its financial
projections; 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 on-going or planned clinical trials
will be initiated or completed on the timelines 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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