Vical Incorporated
(Nasdaq: VICL) announced today the initiation of a National Institutes of
Health (NIH) sponsored Phase 1 clinical trial of a "prime-boost" vaccine
approach designed to prevent or control disease in patients already
infected with HIV. The trial involves priming an immune response with
multiple doses of a plasmid DNA vaccine, based on Vical's proprietary DNA
delivery technology, and boosting the response with a single dose of
adenoviral vector vaccine given at a later date.
The vaccine was developed by scientists at the Dale and Betty Bumpers
Vaccine Research Center (VRC) of the National Institute of Allergy and
Infectious Diseases (NIAID), part of the NIH, and was manufactured by
Vical. The vaccine incorporates HIV genetic material from the three most
globally important HIV subtypes, clades A, B and C, which are involved in
about 85 percent of all HIV infections around the world. The same vaccine
is currently being tested in a preventive setting through a multinational
Phase 2 trial initiated in October 2005. Results from a Phase 1 trial in
HIV-uninfected subjects showed that the prime-boost approach was well
tolerated and effective in producing potent cellular and antibody immune
responses, including specific responses against each of the HIV subtypes.
The new Phase 1 trial is the first therapeutic application of a
"prime/boost" vaccine against HIV in the VRC program.
"Antiviral drugs have dramatically improved the outlook for
HIV-infected individuals," said Vijay B. Samant, Vical's President and
Chief Executive Officer, "but complicated treatment regimens, serious side
effects and increasing drug resistance call for better long-term solutions.
A post-infection vaccine that would allow the immune system to suppress
viral loads could provide significant benefits both to prevent disease
symptoms in the individual and potentially to reduce disease transmission
between individuals. We are excited that our collaborators at the VRC have
advanced into human testing with this novel vaccine application."
The vaccine used in the Phase 1 trial incorporates parts of four HIV
genes. Three of these vaccine components are modified versions of HIV genes
called gag, pol and nef, synthetically made based on sequence from clade B,
the subtype that predominates in Europe and North America. The fourth
vaccine component is a modified version of the HIV gene named env. The env
gene codes for a protein on the outer coat of the virus that allows it to
recognize and attach to human cells. VRC scientists were the first to
combine modified env from clades A and C, which are the most common in
Africa and parts of Asia, with the modified env gene from clade B. The
study is being conducted at the NIH Clinical Center. The trial is
double-blinded and placebo-controlled, and will evaluate safety,
tolerability and immune response. Subjects will continue highly active
antiretroviral therapy (HAART) throughout the trial.
Vical has produced multiple DNA vaccines for the VRC against infectious
disease targets including Ebola, severe acute respiratory syndrome (SARS),
and West Nile virus, all of which have advanced into Phase 1 clinical
trials over the past three years.
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 has developed 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 serve
significant unmet medical needs. Additional information on Vical is
available at vical/.
This press release contains forward-looking statements subject to risks
and uncertainties that could cause actual results to differ materially from
those projected, including: whether VRC and the NIH Clinical Center will
complete the trial as planned; whether the HIV vaccine or any other 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.
Vical Incorporated
vical/