Vical Incorporated
(Nasdaq: VICL) announced that data from a study in mice demonstrated
the potential of its patented Vaxfectin(TM) adjuvant to be used as a
dose-sparing agent with a protein-based H5N1 pandemic influenza vaccine
currently stockpiled by the U.S. government. Dose-sparing ability could be
critical in extending limited vaccine supplies to protect the greatest
number of people in the event of a pandemic influenza outbreak. Alain
Rolland, Pharm.D., Ph.D., Vical's Senior Vice President of Product
Development, presented the data at the World Vaccine Congress (Lyon,
France, October 8 - 10).
Vaxfectin(TM)-formulated Measles DNA Vaccine
The company also announced that a measles DNA vaccine formulated with
the company's Vaxfectin(TM) adjuvant elicited sustained protective levels
of neutralizing antibodies in infant (6 - 10 week old) nonhuman primates
confirmed by complete protection following challenge one year after
intradermal vaccination, with no clinical signs of disease and no
culturable virus after challenge. In May, the company announced similar
results in juvenile (1 - 2 year old) nonhuman primates. Both measles
studies were conducted in collaboration with Diane E. Griffin, M.D., Ph.D.,
Alfred and Jill Sommer Professor and Chair of Molecular Microbiology and
Immunology, Johns Hopkins Bloomberg School of Public Health, under a grant
from the Bill and Melinda Gates Foundation.
"We continue to expand the database demonstrating the dose-sparing and
immunogenicity-enhancing capabilities of our Vaxfectin(TM) adjuvant," said
Dr. Rolland, "as well as its potential safety and tolerability advantages.
Our lead DNA vaccine candidate against H5N1 influenza, formulated with
Vaxfectin(TM), provided 100% protection in mice and ferrets against lethal
challenges, and is currently in Phase 1 human testing. We are encouraged by
the recent influenza and measles data, and look forward to further
evaluation of Vaxfectin(TM)."
Study Details
In the recent influenza study, mice were vaccinated with U.S.
government-supplied H5N1 vaccine (rgA/Vietnam/1203/2004 - BEI Resources,
Catalog No. NR-4143), with or without the Vaxfectin(TM) adjuvant, and
evaluated for antibody responses by Enzyme-Linked ImmunoSorbent Assay
(ELISA). After a single injection, the Vaxfectin(TM)-formulated vaccine
yielded five-fold higher antibody responses at the same dose as the
unformulated vaccine, and comparable or better antibody responses at
one-third the dose of unformulated vaccine. After a second injection, the
Vaxfectin(TM)-formulated vaccine yielded nine-fold higher antibody
responses at the same dose as the unformulated vaccine, and five-fold
better antibody responses at one-third the dose of the unformulated
vaccine.
In an earlier influenza study, the company demonstrated that the
Vaxfectin(TM) adjuvant significantly boosted the immune response to a
protein-based seasonal influenza vaccine. Mice were vaccinated with
trivalent inactivated influenza vaccine (Sanofi-Pasteur Fluzone(R)
2005-2006 Formula commercial product), with or without the Vaxfectin(TM)
adjuvant, and evaluated for antibody responses through hemagglutination
inhibition (HI) titers. The Vaxfectin(TM)-formulated vaccine yielded
significantly higher antibody responses than the unformulated vaccine at
the same dose as well as a dose-sparing effect.
In the recently completed measles study in infant nonhuman primates,
neutralizing antibody levels exceeded the accepted protection threshold
prior to the second injection at Week 4, peaked at Week 8, and remained
above the threshold at least through the 20-week follow-up period. Animals
were challenged by intratracheal inoculation after one year, resulting in
complete protection of all vaccinated animals. None of the vaccinated
animals had disease symptoms or culturable levels of measles virus, in
contrast to negative control animals which all had rashes and positive
virus cultures. No adverse events related to the vaccination were observed.
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 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 Vical or others will continue
evaluation of Vaxfectin(TM) as an adjuvant for vaccines against influenza
or measles; 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 or measles DNA vaccine candidates; whether H5N1 or other strains
of 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 influenza; whether the measles vaccine will be effective
in protecting juvenile or infant humans against infection or disease;
whether the influenza or measles vaccines or any other product candidates
will be shown to be safe and effective; the timing, nature and cost of
clinical trials; 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; 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
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