Inviragen Initiates DENVax Phase 1 Clinical Testing in Colombia
Fort Collins, CO and Medellin, Colombia - October 25, 2010
Inviragen, a company developing vaccines to protect against infectious
diseases worldwide, and the Program for the Study
and Control of Tropical Diseases (PECET), jointly announced
the initiation of a Phase 1 clinical trial of DENVax(TM) in Colombia. DENVax is an investigational vaccine
designed to provide protection against all four dengue virus serotypes. The trial will measure the safety
of DENVax as well as the immune responses induced by the vaccine in healthy adults in Rionegro, Colombia.
The clinical trial is being conducted in collaboration with PECET at Universidad de Antioquia. DENVax is
also being studied in an ongoing U.S. Phase 1 trial that commenced in May 2010.
"Inviragen is committed to developing a dengue vaccine that can be safely used to combat
outbreaks of dengue fever worldwide," commented Professor Jorge Osorio, Inviragen's chief scientific officer. "This trial will determine whether
DENVax is safe and immunogenic in patients who live in endemic countries such as Colombia and can ultimately
benefit from the vaccine."
Dengue fever is common to Latin America and can occur throughout the year. According
to Colombia's national health institute, the Instituto Nacional de Salud, more than 120,000 cases of
dengue fever were reported leading to 115 deaths so far in 2010. This figure is up approximately two-fold
from past years. The increase in dengue incidence has been attributed by some experts to warmer
temperatures due to a strong El Niño weather pattern as well as heavy rains.
"Dengue is endemic in tropical countries such as Colombia and treatment of the
disease is costly, creating a significant drain on public health resources," commented Professor
Ivan Dario Vélez, director of PECET and principal investigator for the trial. "PECET is excited to
be a part of the clinical development of such an urgently needed vaccine."
In Inviragen's Colombian Phase 1 study, an estimated 112 healthy adult volunteers
will receive injections of a placebo or two doses of the investigational DENVax vaccine. As in the U.S.
Phase 1 trial, the study will assess the safety and immune responses after both subcutaneous and
intradermal delivery of DENVax. For more information on this study, please refer to http://clinicaltrials.gov.
About DENVax
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 Dengue Fever
More than 3.6 billion people live in countries that have frequent dengue outbreaks.
The four dengue viruses are spread by the mosquito, Aedes aegypti, which is found throughout
tropical and subtropical regions. According to the
Pediatric Dengue Vaccine Initiative,
dengue viruses cause an estimated 30 to 50 million cases of debilitating dengue fever and
2.1 million cases of severe dengue disease leading to over 20,000 deaths every year.
For more information on dengue fever, please refer to the
CDC and
WHO websites.
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 PECET
The Program of Study and Control of Tropical Diseases (PECET) is a multidisciplinary research group
affiliated with the Faculty of Medicine at Universidad de Antioquia. PECET was founded in 1986 and
focuses on development of strategies for the prevention and control of tropical diseases in Colombia.
PECET's activities include laboratory and clinical research, teaching, and extension services in the
community. Please see http://pecet-colombia.org
for more details.
Contact at Inviragen
Dr. Dan Stinchcomb
+1.970.372.4754
dstinchcomb@inviragen.com
Media Contact:
Aline Schimmel
+1.312.238.8957
aschimmel@scientapr.com
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