Vical Receives
U.S. Patent for Cytomegalovirus Vaccines
SAN DIEGO,
Feb. 16, 2011 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL) announced today
the issuance of U.S. Patent No. 7,888,112 covering
DNA vaccines for cytomegalovirus (CMV) containing
specific gene sequences and formulated with
Vical's
Vaxfectin® adjuvant.
Past development by others of protein-based
prophylactic CMV vaccines has focused on
antibody-mediated immune responses against the CMV
glycoprotein B (gB) antigen, which has achieved up
to 50% protective efficacy. The new '112 patent
covers DNA vaccines containing codon-optimized
versions of genes encoding gB and CMV phosphoprotein
65 (pp65) antigens, formulated with Vical's Vaxfectin®
adjuvant. It adds to Vical's family of patents in the United States and other
key regions based on the company's discovery that
administering genetic sequences such as DNA or RNA
into the body, without the use of viral delivery
vehicles, may cause expression of the proteins
encoded by the genetic sequences.
Vical has additional
issued patents covering the composition and use of
the Vaxfectin® adjuvant.
Vical's
CyMVectin™ Prophylactic CMV Vaccine
Mothers who are infected with CMV during
pregnancy can transmit the virus to the fetus, where
it affects the development of the central nervous
system. Congenital CMV is the leading infectious
disease cause of birth defects in
the United States,
similar to rubella in the '40s and '50s before an
effective vaccine was available. CMV-infected
infants can be affected by blindness, deafness and
mental retardation, and these consequences are
frequently undiagnosed until the child reaches
several years of age. Widespread vaccination of
adolescent females has the potential to
significantly reduce or even eliminate congenital
CMV over time, and this market segment offers a
significant commercial vaccine target. The
successful launch of Merck's Gardasil®
vaccine for the prevention of human papillomavirus (HPV),
a primary cause of cervical cancer, has demonstrated
the size and receptivity of the adolescent female
vaccine market.
Targeting prevention of infection in females of
child-bearing potential, Vical is developing CyMVectin™,
a prophylactic DNA vaccine encoding the CMV gB and
pp65 antigens and formulated with
Vical's
Vaxfectin® adjuvant designed to enhance
both antibody and T-cell responses. The U.S.
Food and Drug Administration (FDA)
has allowed the company's Investigational New Drug
(IND) application for a Phase 1 trial of the
CyMVectin™ vaccine, and Vical is exploring collaborative opportunities for
further development and commercialization.
Vical's
TransVax™ Therapeutic CMV Vaccine
CMV affects 30% to 60% of patients undergoing
transplant procedures, causing transplant rejection,
serious illness and even death if untreated.
Expensive and toxic antiviral drug therapy is used
to control the disease, but does not eliminate the
infection. There is no approved vaccine against CMV.
Protein-based vaccines that predominantly result in
antibody responses to CMV may have limited
effectiveness in transplant patients. Live,
attenuated vaccines can induce both antibody and
cellular immune responses, but pose a potential
safety concern, particularly for immunocompromised
patients, of causing the disease they are intended
to prevent.
For transplant patients, Vical is developing TransVax™, a therapeutic DNA
vaccine encoding the CMV gB and the pp65 antigens,
and formulated with a poloxamer designed to enhance
primarily a cellular immune response. Vical's TransVax™ vaccine has
orphan drug designation for transplant patients. In
September 2010,
Vical
announced encouraging results from a completed Phase
2 trial of the TransVax™ vaccine in patients
undergoing hematopoietic stem cell transplants. The
company is currently meeting with regulatory
authorities to confirm the design of a planned Phase
3 trial which is expected to begin in the second
half of 2011.
About CMV
CMV is a herpes virus that infects more than half
of all adults in the United States by age 40,
and is even more widespread in developing countries.
While a healthy immune system typically protects an
infected person against CMV disease, it rarely
succeeds in eliminating the infection, and those
whose immune systems are not fully functional are at
high risk of CMV reactivation, potentially leading
to severe illness or death. Those at greatest risk
include transplant patients and infants born to
mothers who first become infected during pregnancy. Vical is pursuing two different
vaccine approaches for these distinct market
segments.
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.
The
Vical Incorporated
logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=5768.
This press release contains forward-looking
statements subject to risks and uncertainties that
could cause actual results to differ materially from
those projected. Forward-looking statements include
statements about the scope of coverage of and
potential applications for Vical's patents, the potential uses and benefits
of
Vical's technologies and their potential
application in vaccines against CMV, the CyMVectin™
prophylactic vaccine and the TransVax™ therapeutic
vaccine, as well as the company's focus,
collaborative partners, and independent and
partnered product candidates. Risks and
uncertainties include whether Vical's issued patents will be challenged and
whether such challenges will have an adverse effect
on the scope or validity of the patents; whether
Vical
will pursue enforcement of its issued patents or be
successful in any such enforcement efforts; whether Vical will successfully prosecute additional
patent applications and if so, whether such
applications will lead to the issuance of additional
patents; whether Vical will enter into any development or
commercialization collaborations for its CMV vaccine
programs; whether Vical or others will continue
development of CyMVectin™, TransVax™ or any other
product candidates; whether the CyMVectin™ trial
allowed by the FDA will be conducted;
whether the TransVax™ Phase 3 trial design will be
allowed by regulatory authorities, and if so,
whether the trial will begin in the second half of
2011, if at all; whether
Vical or its collaborative partners will seek
or gain approval to market TransVax™, CyMVectin™, 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.
CONTACT: Alan R. Engbring
(858) 646-1127
Website: www.vical.com
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