Inviragen Initiates DENVax Phase 1 Clinical Testing in Colombia

FORT COLLINS, Colo. & MEDELLÍN, Colombia--(BUSINESS WIRE)--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 DENVaxTM 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's DENVax 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 four-way mixture of the three engineered viruses and the original DEN-2 strain. Inviragen has completed preclinical testing, formulation, and manufacturing of DENVax.

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.

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