FOR IMMEDIATE RELEASE [
Burlingame, CA and Covington, KY, 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 contract research organization in the world for quality
, to conduct this trial in Brazil.
Cameron Durrant, MD, MBA, chief executive officer of Humanigen, said, “COVID-19 is a global crisis and we are committed to offering assistance to patients across the world that are impacted by the pandemic. We hope that expanding the study of lenzilumab to research centers in Brazil, a country with surging rates of COVID-19, will offer patients much needed access to a leading COVID-19 therapeutic candidate.”
Currently, Brazil has the second highest reported rates of COVID-19 infection in the world, second only to the US.
“Access to clinical trials is critical for healthcare providers in the fight against COVID-19,” remarked Timothy Schroeder, chief executive officer of CTI. “We are proud to collaborate with our colleagues at Humanigen to extend the reach of the Phase III study of lenzilumab and bring a potential treatment option to those in need.”
More details on Humanigen’s programs in COVID-19 can be found on the company’s website at www.humanigen.com
under the COVID-19 tab, and details of the US Phase III potential registration study can be found at clinicaltrials.gov using ClinicalTrials.gov Identifier NCT04351152.