17 Oct 2012, BioSpectrum Bureau , BioSpectrum
Singapore: 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 phase I clinical trial represents an important milestone in providing a potential innovative solution to combat H5N1 virus infections in humans," said founder and CEO of Fab'entech, Dr Bertrand Lépine. "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 injection of specific anti-H5N1 polyclonal immunoglobulins is likely to provide immediate protection for people who have been infected with or exposed to the virus."
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). The clinical trial in Singapore will involve 16 healthy adult volunteers who will be monitored for five weeks. It will be a double blinded, placebo controlled study, performed in strict compliance with good clinical practices (GCP).