Therapeutic antibody discovery and development company Theraclone Sciences has begun a Phase II viral challenge clinical study of TCN-032, a monoclonal antibody, for the treatment of Influenza A.
The randomised, double-blind Phase II study will determine the safety and efficacy profile of TCN-032 in normal volunteers challenged with influenza A.
Study will randomise all the subjects in 1:1 ratio with either TCN-032 or placebo following the viral challenge, and will monitor for the development of clinical symptoms and viral shedding.
Theraclone Sciences chief medical officer Dr Eleanor Ramos said both severe seasonal and pandemic influenza represent a major global health threat, with limited treatment options due to the virus’ ability to rapidly mutate.
"TCN-032 was discovered through our I-STAR technology and targets virtually all influenza A strains," Ramos said.
"This proof-of-efficacy study is an important milestone for Theraclone in the development of a universal therapeutic for patients with serious influenza A infections. Data from the study are expected in 1H 2013."
Zenyaku Kogyo will partially support the trial through its multi-year research contract with Theraclone to discover essential antibody targets and develop candidates to treat pandemic and severe seasonal influenza.
Zenyaku Kogyo has an exclusive license to Theraclone’s influenza monoclonal antibody programme in the territory of Japan, while Theraclone controls development and commercialisation rights outside Japan.
Image: Transmission electron micrograph of influenza A virus, late passage. Photo: Courtesy of CDC/ Dr Erskine Palmer.