Title: Vical's Vaxfectin(TM) Adjuvant With Needle-free Delivery
Enhances DNA Vaccine Performance; Yields Antibody Responses Comparable to Electroporation
Without Tolerability Issues Date: 5/23/2007 6:35:00 AM
MALAGA, Spain, May 23 /PRNewswire-FirstCall/ -- Vical Incorporated (Nasdaq: VICL) today
announced that in a recently completed animal study, a DNA vaccine formulated with the
company's patented Vaxfectin(TM) adjuvant and delivered by needle-free injection yielded
significantly higher antibody responses than an unformulated DNA vaccine delivered by
needle and syringe. In a separate animal study, electroporation following injection of
unformulated vaccine yielded comparable improvements in antibody responses, but
electroporation required anesthesia of the animals while needle-free injection of
Vaxfectin(TM)-formulated vaccine was administered safely and tolerably without anesthesia.
"The dose-sparing and immunogenicity-enhancing capabilities of the Vaxfectin(TM)
adjuvant have been demonstrated in a range of vaccine applications in various animal
models," said Alain P. Rolland, Pharm.D., Ph.D., Vical's Senior Vice President of
Product Development, "but the potential safety and tolerability advantages of
Vaxfectin(TM) compared with alternative DNA delivery enhancement options are making it our
preferred choice for new development projects. We look forward to beginning the initial
human testing of a Vaxfectin(TM)-formulated DNA vaccine for pandemic influenza,
anticipated in the second half of 2007, and to continued exploration of Vaxfectin(TM)'s
use in optimizing efficacy and safety for future prophylactic or therapeutic
applications."
Both studies were conducted in rabbits with DNA vaccines encoding cytomegalovirus (CMV)
glycoprotein B (gB). The vaccines were either unformulated -- using standard
phosphate-buffered saline (PBS) -- or formulated -- using the company's Vaxfectin(TM)
adjuvant in PBS. Vaxfectin(TM)-formulated vaccines were injected with a needle-free
device. Unformulated vaccines were injected with needle and syringe followed in some
animals by electroporation using either a constant voltage multi-needle device or a
constant current multi-needle device. Both electroporation devices and the
Vaxfectin(TM)/needle-free device combination elicited significant increases in production
of gB-specific antibodies compared with unformulated vaccine delivered by needle and
syringe alone and all three enhancements elicited comparable production of gB-specific
antibodies.
Vical research scientist Jukka Hartikka, Ph.D., presented the data at the DNA Vaccines
2007 conference (Malaga, Spain, May 23 - 25). Other topics of interest at the conference
included a novel potency assay for DNA vaccines, presented by Keith Hall, Vical's Senior
Director of Quality Control and Assay Development; and a DNA vaccine for cancer, presented
by Vical's licensee, Merck & Co., Inc.
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.
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 Vical or others will continue development of DNA vaccines; whether
Vaxfectin(TM) formulation, needle-free delivery or electroporation will sufficiently
enhance immunogenicity of DNA vaccines; whether initial human testing of a
Vaxfectin(TM)-formulated DNA vaccine for pandemic influenza will begin as planned, if at
all; whether safety and tolerability demonstrated in animal studies will correlate to
results in humans; whether additional enhancement options may become available, and if so,
whether they will be used in future applications; 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 others will seek or gain approval to market any product
candidates; whether Vical or others 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: www.vical.com
SOURCE Vical Incorporated
-0- 05/23/2007
/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: Spain, California
IN: HEA MTC BIO
SU: TRI TDS
TU
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2319 05/23/2007 06:35 EDT http://www.prnewswire.com
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