Publication
Highlights Allovectin-7® Phase 2 Safety and Efficacy
Results in Melanoma
SAN DIEGO,
Jan. 11, 2011 (GLOBE NEWSWIRE) --
Vical Incorporated (Nasdaq:VICL) today announced a new
publication summarizing results from the company's completed trials
of Allovectin-7® including systemic responses and an
excellent safety profile in patients with metastatic melanoma. An
article published in the January issue of Immunotherapy1
noted that the U.S. incidence of melanoma is increasing rapidly,
that current therapies are inadequate and toxic, and that melanoma
is responsive to immune-stimulating drugs like Allovectin-7®.
A Phase 3 trial evaluating the safety and efficacy of Allovectin-7®
compared with standard chemotherapy is expected to complete final
follow-ups later this year.
The most recently completed Phase 2 trial was a single-arm,
open-label study in which 127 chemo-refractory or chemo-intolerant
subjects were treated with high-dose Allovectin-7®. There
were no treatment-related Grade 3 or Grade 4 adverse events, and no
withdrawals from the trial for tolerability. The overall response
rate for the 127 patients receiving the high-dose treatment was
11.8%, with 4 complete responders and 11 partial responders. The
median duration of response was 13.8 months and median survival was
18.8 months. These data compare favorably against historical
controls from other studies in metastatic melanoma.
Findings from the Phase 2 trial were incorporated into the design
of a Phase 3 pivotal trial through a Special Protocol Assessment
agreement with the U.S. Food and Drug Administration (FDA):
- The Phase 3 trial sought patients likely to have functional
immune systems.
-
Vical's Phase 3 trial
was among the first for metastatic melanoma to exclude
patients with elevated levels of lactate dehydrogenase
(LDH), a key biomarker predictive of prognosis.
- The trial excluded patients previously treated with
chemotherapy.
- The Phase 3 trial sought patients healthy enough to remain
on study for at least two 8-week treatment cycles, the median
time to response in the Phase 2 study.
- The trial excluded patients with metastases to the brain
or liver.
- Response Evaluation Criteria In Solid Tumors (RECIST)
standards were modified for the Phase 3 protocol to allow
treatment continuation through two cycles at the physician's
discretion, even if patients develop new melanoma lesions
within defined limits.
-
Vical's Phase 3 trial
was designed to capture the long-term benefits of immunotherapy
compared with chemotherapy, as all responses in the Phase 2
trial were durable (= 6 months).
- The primary endpoint compares overall response rates at
24 weeks or more after randomization.
- The study will also evaluate survival as well as safety
and tolerability.
The Phase 3 trial, initiated in January 2007, is
evaluating Allovectin-7® as first-line therapy in
patients with Stage III or IV recurrent metastatic melanoma.
Vical completed enrollment in February 2010 of
approximately 390 chemo-naive patients randomized on a 2:1 basis:
approximately 260 for treatment with Allovectin-7® and
approximately 130 for treatment with either dacarbazine or
temozolomide. The company expects to complete patient follow-up and
lock the Phase 3 clinical trial database in the second half of 2011.
Allovectin-7® is a novel gene-based immunotherapeutic
with a unique mechanism of action that is fundamentally different
from currently approved treatments, and has the potential to be the
first new primary treatment approved for metastatic melanoma in
nearly 20 years.
Vical estimates that the worldwide market for Allovectin-7®
as a treatment for metastatic melanoma could exceed $500
million annually, and applications for other types of cancer
could further expand its total use.
Because the mechanism of action for Allovectin-7® is
not melanoma-specific, it has the potential to be used in other
types of solid tumors. AnGes MG, Inc., has licensed
rights to commercialize Allovectin-7® in specified Asian
countries, and is primarily interested in developing Allovectin-7®
as a treatment for head and neck cancer, which presents a
significant unmet medical need in
Asia. Allovectin-7® is still available for
licensing in North
America,
Europe and other regions.
About
Vical
Vical researches and
develops biopharmaceutical products based on its patented DNA
delivery technologies for the prevention and treatment of serious or
life-threatening diseases. Potential applications of the company's
DNA delivery technology include DNA vaccines for infectious diseases
or cancer, in which the expressed protein is an immunogen; cancer
immunotherapeutics, in which the expressed protein is an immune
system stimulant; and cardiovascular therapies, in which the
expressed protein is an angiogenic growth factor. The company is
developing certain infectious disease vaccines and cancer
therapeutics internally. In addition, the company collaborates with
major pharmaceutical companies and biotechnology companies that give
it access to complementary technologies or greater resources. These
strategic partnerships provide the company with mutually beneficial
opportunities to expand its product pipeline and address significant
unmet medical needs. Additional information on
Vical is available at
www.vical.com.
The Vical
Incorporated logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=5768
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
whether Vical
or others will continue developing Allovectin-7®; whether
Allovectin-7® will be approved as primary treatment for
metastatic melanoma in
the United States
or any other countries; whether the Phase 3 trial will meet its
primary endpoint or any other trial endpoints; whether Allovectin-7®
will achieve a higher response rate than chemotherapy after 24 weeks
or more; whether any patients will derive benefit from treatment
with Allovectin-7®; whether the safety profile of
Allovectin-7® will continue through trial completion;
whether Allovectin-7® will generate revenues exceeding
$500 million annually for metastatic melanoma, if any;
whether Allovectin-7® will be successfully developed and
commercialized for other solid tumor indications; whether AnGes will
develop or commercialize Allovectin-7® in
Asia
for head and neck cancer or any other indication; whether any
product candidates will be shown to be safe and effective in
clinical trials; the timing, nature and cost of clinical trials;
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.
1Chowdhery R & Gonzalez R. Immunologic therapy
targeting metastatic melanoma: Allovectin-7®.
Immunotherapy 2010, 3(1):17-21.
CONTACT: Alan R. Engbring
(858) 646-1127
Website: www.vical.com