Humanigen Inc (OTCQB:HGEN) announced Monday that Brazilan regulators have granted the company permission to begin a Phase 3 study of its drug lenzilumab on coronavirus (COVID-19) patients in the country.
The study will follow the same protocol approved by the US Food and Drug Administration in April - a randomized, placebo-controlled, double-blind clinical trial format for severe and critical coronavirus patients with a high risk of disease progression.
The study is now set to begin recruiting patients, the company said.
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“COVID-19 is a global crisis and we are committed to offering assistance to patients across the world that are impacted by the pandemic,” Humanigen CEO Cameron Durant said in a statement.
“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,” he added.
To conduct the trial, Humanigen is working with Clinical Trials & Consulting (CTI), which was recently named the top global contract research organization, the company said.
“Access to clinical trials is critical for healthcare providers in the fight against COVID-19,” CTI CEO Timothy Schroeder said. “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.”
Brazil has the second-highest reported number of coronavirus cases in the world, behind only the US, according to The New York Times.
Lenzilumab is designed to treat the cytokine storm, an overactive immune system response to the coronavirus that can cause fever and inflammation and potentially lead to organ failure.
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