Title: Vical's Vaxfectin(TM) Adjuvant Achieves Dose-Sparing Effect
With Seasonal Influenza Vaccine Date: 4/11/2007 6:30:00 AM
SAN FRANCISCO, April 11 /PRNewswire-FirstCall/ -- Vical Incorporated (Nasdaq: VICL)
today announced that a seasonal influenza vaccine formulated with the company's
Vaxfectin(TM) adjuvant generated up to 60-fold higher antibody responses than an
unformulated vaccine at the same dose in a recently completed study in mice. Formulation
of sanofi pasteur's Fluzone(R) commercial vaccine with Vaxfectin(TM) also allowed a nearly
10-fold reduction in vaccine dose while generating equivalent or better antibody responses
compared with unformulated vaccine, even at the lowest doses tested. Alain P. Rolland,
Pharm.D., Ph.D., the company's Senior Vice President of Product Development, presented the
data at the Drug Delivery 2007 meeting (San Francisco, April 9 - 11).
Vical is developing its own Vaxfectin(TM)-formulated DNA vaccine designed to protect
against emerging strains of influenza virus that have the potential to cause a pandemic.
In previously reported studies conducted at St. Jude Children's Research Hospital, Vical's
lead Vaxfectin(TM)-formulated, DNA vaccine candidate provided 100% protection in mice and
ferrets against lethal challenges with a highly pathogenic strain of H5N1 influenza virus.
Initial human testing of Vical's influenza DNA vaccine is expected to begin in the second
half of 2007.
Vical tested the Vaxfectin(TM) adjuvant with Fluzone(R) seasonal influenza vaccine to
evaluate its potential to ease the anticipated shortage of stockpiled pandemic influenza
vaccine and the limited global vaccine manufacturing capacity. In separate studies
conducted by others, stockpiled sanofi pasteur H5N1 pandemic influenza vaccine with no
adjuvant achieved target levels of antibodies in less than half the subjects after two 90
mcg doses -- a total of six times the normal 15 mcg dose of each strain that provides 75%
to 90% protection against seasonal influenza.
The new Fluzone(R) study data confirm and expand on an earlier study in mice, presented
last year, which suggested the potential for Vaxfectin(TM) to be used as a dose-sparing
agent with conventional influenza vaccines. Both studies used the Fluzone(R) 2005-2006
Formula trivalent inactivated seasonal influenza vaccine. In the recent study, mice were
vaccinated with 1, 3, or 9 mcg of Fluzone(R) alone, or Fluzone(R) formulated with one of
two dose levels of Vaxfectin(TM). Immune responses were evaluated by measuring
hemagglutination inhibition (HI) antibody titers, the accepted standard correlate of
protection for conventional influenza vaccines, against a single influenza strain included
in the trivalent inactivated vaccine, as well as total antibody titers against all three
of the strains included in the vaccine. Vaxfectin(TM)-formulated vaccines yielded HI
antibody titers up to 30-fold higher, and total antibody titers up to 60-fold higher than
unformulated vaccines at the same dose. Vaccines formulated with even the lowest tested
dose of Vaxfectin(TM) yielded equivalent or better immune responses at the 1 mcg dose than
unformulated vaccines at the 9 mcg dose, confirming the dose-sparing potential of
Vaxfectin(TM). The improved performance of Vaxfectin(TM) in the latest studies reflected
further optimization of the Vaxfectin(TM)/vaccine ratio at each of three dosing levels
tested in mice.
Vaxfectin(TM) was designed by Vical to increase the immune response to DNA vaccines,
and Vaxfectin(TM)-formulated DNA vaccines have demonstrated good tolerability and adjuvant
activity in multiple animal models, including nonhuman primates. The Fluzone(R) data
suggest that Vaxfectin(TM) could provide a dose-sparing effect with the
government-stockpiled H5N1 pandemic influenza vaccine, also produced by sanofi pasteur.
Since neither Fluzone(R) nor the sanofi pasteur H5N1 pandemic influenza vaccine are
formulated with an adjuvant, Vaxfectin(TM) could, if approved, simply be added to either
vaccine prior to administration. Vaxfectin(TM) may have potential applications as an
adjuvant for other protein-based vaccines as well. The company holds patents in the United
States covering Vaxfectin(TM) and its use with conventional vaccines against infectious
diseases and cancer, and in both the United States and Europe covering the use of
Vaxfectin(TM) with DNA vaccines.
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 evaluation of Vaxfectin(TM) as an
adjuvant for conventional vaccines against seasonal or pandemic influenza; whether
Vaxfectin(TM) will be used as a dose-sparing agent with conventional influenza vaccines
against seasonal or pandemic influenza strains; whether Vical or others will continue
development of the pandemic influenza DNA vaccine candidate; whether H5N1 or other strains
of avian influenza will emerge as pandemic threats; whether the company's DNA vaccine
candidate will be effective in protecting humans against H5N1 or other strains of avian
influenza; whether the influenza 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 Vaxfectin(TM) will provide a dose-sparing effect with the government-stockpiled
H5N1 pandemic influenza vaccine; whether Vaxfectin(TM) will be used with other
protein-based vaccines; whether Vical or its collaborative partners will seek or gain
approval to market the influenza vaccine or any other product candidates; whether Vical or
its collaborative partners will succeed in marketing the influenza vaccine or any other
product candidates; whether the company's issued patents will be challenged and whether
such challenges will have an adverse effect on the scope of the patents; whether the
company will enforce its issued patents or will be successful in any enforcement efforts;
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- 04/11/2007
/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
IN: HEA MTC BIO IDC
SU: TRI TDS
SF-CV
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