Inviragen’s Dengue
Vaccine to Begin Clinical Testing
Fort Collins,
Co, May 19, 2010
Inviragen has announced the initiation of the first clinical
trial of its vaccine to protect against dengue fever. The trial, to be conducted
at Saint Louis University, is designed to assess the safety of Inviragen’s
investigational dengue vaccine.
“Initiating this first clinical study of DENVaxTM is an important milestone
for Inviragen,” commented Dr. Dan Stinchcomb, the company’s Chief
Executive Officer. “The transition of this vaccine from the bench to
the clinic is the culmination of many years of work by Inviragen, scientists
at the Centers for Disease Control and Prevention (CDC) and our international
collaborators.”
Inviragen’s DENVax investigational vaccine, developed by researchers
at the CDC’s Division of Vector-Borne Diseases, is based on an attenuated
DEN-2 virus that generates long- lasting anti-dengue immune responses. CDC
scientists engineered this clinically tested, weakened DEN-2 virus to express
DEN-1, DEN-3 or DEN-4 structural genes. DENVax is a mixture of the three engineered
viruses and the original DEN-2 strain. Inviragen completed preclinical testing,
formulation, and manufacturing of the tetravalent DENVax vaccine to be used
in the upcoming clinical trials.
“In animal model studies, DENVax is safe, induces neutralizing antibodies
to all four dengue serotypes and protects against dengue infection,” noted
Dr. Jorge Osorio, Inviragen’s Chief Scientific Officer. “An Investigational
New Drug application (IND) has been filed and reviewed by the Food and Drug
Administration (FDA). We look forward to testing the safety and immunogenicity
of the vaccine in the Phase 1 trial conducted at Saint Louis University.”
Saint Louis University is one of the Vaccine and Treatment Evaluation Units
funded by the National Institute of Allergy and Infectious Diseases (NIAID),
which is part of the National Institutes of Health. For the clinical study,
72 healthy adult volunteers will receive injections of a placebo, a lower dose
or a higher dose of the investigational vaccine. The
vaccine will be administered in two doses, three months apart, either between
the layers of the skin as an “intradermal” shot or under the skin
as a “subcutaneous” injection.
“Finding a safe and effective vaccine for dengue is a global health priority,” said
Sarah George, M.D., assistant professor in the division of infectious diseases
at Saint Louis University and principal investigator of the study. “Approximately
3.6 billion people worldwide – more than half of the world’s population – now
are at risk of contracting dengue disease.”
Thirty-six million cases of dengue fever are thought to occur per year worldwide.
The most severe form of the disease, dengue hemorrhagic fever, leads to the
death of approximately 20,000 people annually worldwide. Both the number of
reported cases and the number of countries affected have been on the rise,
and the disease could continue to spread because of increasing urbanization,
international travel and global warming. Dengue is a major risk for international
travelers: dengue cases among travelers outnumber malaria cases in every continent
except Africa.
In addition to the clinical trial in the U.S., Inviragen anticipates performing
additional human clinical testing of DENVax in Colombia and Singapore.
Contact: Dr. Dan Stinchcomb, +1.970.372.4754
About Inviragen, Inc.
Inviragen is focused on developing vaccines to protect against infectious diseases
worldwide. Inviragen's lead product candidate is a vaccine to protect against
dengue fever. Inviragen is also developing vaccines to protect against hand,
foot and mouth disease and Japanese encephalitis, both of which affect millions
of children in Asia. Vaccines in preclinical research stages include a chikungunya
vaccine, a low-cost human papilloma virus vaccine, vaccines to protect against
new forms of influenza, a vaccine to protect against West Nile and a combination
plague/smallpox vaccine for biodefense. Inviragen has offices in Colorado,
Wisconsin and Singapore. Please see www.inviragen.com for
more details.
About Saint Louis University
Established in 1836, Saint Louis University School of Medicine has the distinction
of awarding the first medical degree west of the Mississippi River. The school
educates physicians and biomedical scientists, conducts medical research, and
provides health care on a local, national and international level. Research
at the school seeks new cures and treatments in five key areas: cancer, infectious
disease, liver disease, aging and brain disease and heart/lung disease.
About Charter Life Sciences
Charter Life Sciences (“CLS”) is a life sciences venture capital
firm with offices in Palo Alto, California and Cincinnati, Ohio. CLS focuses
on providing the initial venture capital to companies that are developing innovative
products for significant unmet medical needs. The CLS team draws on its extensive
medical, operational and start-up company experience to work collaboratively
with its portfolio companies to develop their clinical, operational and financing
strategies. For additional information on CLS, please visit www.clsvc.com.
CONTACT:
Ted Rossman/Lisa Kelaita
New Venture Communications
(650) 343-2735
trossman@newventurecom.com
lkelaita@newventurecom.com
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