Title: Multiple NIH Phase 2 HIV Vaccine Trials Using Vical's
Technology Produce Encouraging Results Date: 8/22/2007 4:30:00 PM
SEATTLE, Aug. 22 /PRNewswire-FirstCall/ -- Vical Incorporated (Nasdaq: VICL) announced
today that results from a series of HIV vaccine Phase 2a clinical trials, using a plasmid
DNA (pDNA) vaccine developed by the NIH Vaccine Research Center and manufactured by Vical,
reinforced previously reported Phase 1 conclusions that a "DNA prime-adenoviral
vector boost" vaccine regimen was safe and well-tolerated, and was effective in
inducing T-cell immune responses in up to 70% of the vaccine recipients.
"These recent vaccine trials contribute to the growing body of knowledge
demonstrating plasmid DNA priming as a key factor in achieving significant immune
responses against HIV, a particularly difficult target pathogen, bringing us one step
closer to evaluating the effectiveness of a prime-boost HIV vaccine regimen in a
prophylactic setting," said Vijay B. Samant, Vical's President and Chief Executive
Officer. "The latest International AIDS Vaccine Initiative (IAVI) listing of ongoing
preventive HIV vaccine clinical trials shows that more than half use pDNA either alone or
in combination with other vaccine modalities. We are very pleased that DNA technology is
an integral part of the effort to address this high priority global health problem."
The trials involved priming an immune response with three doses of a pDNA vaccine over
a two month period, based on Vical's proprietary DNA technology, and boosting the response
with a single dose of adenoviral vector vaccine at six months. The three trials,
collectively known as TRIAD, were conducted by the National Institute of Allergy and
Infectious Diseases (NIAID) HIV Trials Vaccine Network (HVTN), the IAVI, and the U.S.
Military HIV Research Program (USMHRP). Richard Koup, M.D., Chief of Immunology at the
Dale and Betty Bumpers Vaccine Research Center (VRC), NIAID, National Institutes of Health
(NIH), highlighted TRIAD summary results and conclusions in an oral presentation,
"Update on safety and immunogenicity of VRC products," at the AIDS Vaccine 2007
conference (Seattle - August 20-23).
About the Vaccine
The "prime-boost" strategy uses two vaccine components given at different
times. Both contain synthetic versions of genes encoding three HIV proteins: gag, pol and
env. The DNA component also includes a gene encoding a fourth protein, nef. The gag, pol
and nef genes come from HIV subtype B, the primary virus found in Europe and North
America. The env gene encodes an HIV coat protein that allows the virus to recognize and
attach to human cells. The vaccine incorporates modified env genes from subtypes A and C,
most common in Africa and parts of Asia, as well as subtype B. These three subtypes
collectively represent about 85 percent of HIV infections worldwide.
The two vaccine components differ in how the genes are packaged. The pDNA component
contains only the specific gene sequences in a pDNA ring, and cannot reconstitute into an
infectious virus. The adenoviral vector component uses a replication-defective adenoviral
vector to shuttle the same non-infectious gene sequences into the body. The pDNA vaccine
used in the trials was developed by VRC scientists and was manufactured by Vical. The
adenoviral vector vaccine was developed by VRC in collaboration with GenVec Inc., of
Gaithersburg, Md., which also manufactured the adenoviral vector vaccine.
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 http://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,
including: whether VRC will continue development of prime-boost or other HIV vaccines and
initiate additional trials as planned; whether immunogenicity results will be predictive
of protection; 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 the HIV
vaccine or any other 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.
Contacts: Investors: Media:
Alan R. Engbring Susan Neath
Vical Incorporated Porter Novelli Life Sciences
(858) 646-1127 (619) 849-6007
Website: http://www.vical.com
SOURCE Vical Incorporated
-0- 08/22/2007
/CONTACT: investors, Alan R. Engbring of Vical Incorporated,
+1-858-646-1127; or media, Susan Neath of Porter Novelli Life Sciences,
+1-619-849-6007, for Vical Incorporated/
/Web site: http://www.vical.com /
(VICL)
CO: Vical Incorporated
ST: California, Washington
IN: HEA MTC BIO
SU: TRI
CS-AA
-- LAW087 --
1286 08/22/2007 16:30 EDT http://www.prnewswire.com
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