Date: 2012-10-10
Type of information:
phase: 1
Announcement: initiation of the trial
Company: Fab’entech (France)
Product: Specific anti-H5N1 polyclonal immunoglobulins
Action mechanism:
Disease: H5N1 avian influenza
Therapeutic area: Infectious diseases
Country: Singapore
Trial
details: The double blinded, placebo controlled study will involve 16 healthy adult volunteers who will be monitored for 5 weeks.
Latest
news: Fab’entech, a French biopharmaceutical company specialized in developing specific polyclonal immunoglobulins against emerging infectious diseases is launching its first clinical trial in humans for its product against the H5N1 Avian Influenza virus. If promising results from animal testing are confirmed, these immunoglobulins may provide a new specific approach for the treatment of subjects infected by or exposed to the H5N1 virus. This approach is based on passive immunotherapy which consists in injecting patients with specific antibodies (immunoglobulins) capable of recognizing, targeting and neutralizing the virus. Based on an already validated and well-established production process at industrial scale, Fab’entech is able to provide highly purified immunoglobulins to neutralize the virus.
The clinical trial will take place in Singapore, located in the Asia-Pacific region where the risk of propagation of H5N1 virus is one of the highest in the world. The good safety profile and the efficacy of this product have been extensively documented in animal studies conducted in collaboration with the INSERM Jean Mérieux BSL-4 Laboratory of Lyon (France).
