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news.Theraclone Sciences has begun a Phase 2 viral challenge clinical study of TCN-032, a monoclonal antibody, for the treatment of Influenza A.
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The randomised, double-blind Phase 2 study is designed to determine the safety and efficacy profile of TCN-032 in normal volunteers challenged with influenza A.
All the subjects in the study will be randomised in 1:1 ratio with either TCN-032 or placebo subsequent to the viral challenge.
Theraclone Sciences chief medical officer 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 added.
"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."
The study will monitor the patients for the development of clinical symptoms and viral shedding.
Zenyaku Kogyo will partially support the trial under contract with Theraclone to discover essential antibody targets and develop candidates to treat pandemic and severe seasonal influenza.