Inviragen commences Phase 1 clinical trial of DENVax dengue vaccine in Colombia

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™ 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.