eClinical Technology and Industy News

Humanigen Expands Phase III Study of Lenzilumab in COVID-19 to Brazil

Excerpt from the Press Release:

Burlingame, CA, August 10, 2020 – Humanigen, Inc., (HGEN) (“Humanigen”), a clinical stage biopharmaceutical company focused on preventing and treating cytokine storm with lenzilumab, the company’s proprietary Humaneered® anti-human granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody, announced that the Brazilian regulatory agency, Anvisa, has granted permission to commence a Phase III study of lenzilumab in patients with COVID-19 in Brazil.

This study, now set to begin recruiting patients in Brazil, follows the same protocol approved by the US Food and Drug Administration in April – a multicenter, randomized, placebo-controlled, double-blinded clinical trial focused on hospitalized severe and critical adult COVID-19 patients at high risk of disease progression. Humanigen is working with CTI Clinical Trial & Consulting (CTI), recently named the top global contract research organization for quality, to conduct this trial in Brazil.

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