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Humanigen planning Phase III clinical trial for lenzilumab to treat coronavirus patients; shares soar

Those with severe cases of the virus experience pneumonia that can progress to acute respiratory distress syndrome (ARDS)

Humanigen, Inc. -
The coronavirus is an infectious disease caused by SARS-CoV-2 and has become a global pandemic, which has now claimed the lives of over 10,000 people

Humanigen Inc (OTCMKTS:HGEN) told investors it wants to carry out a Phase III clinical trial for its lenzilumab to treat so-called cytokine storm, which can lead to acute respiratory distress syndrome (ARDS), which is associated with the current coronavirus pandemic.

Shares in the firm in New York surged 120% to stand at $0.99 each.

The coronavirus is an infectious disease caused by SARS-CoV-2 and has become a global pandemic, which has now claimed the lives of over 10,000 people. Those with severe cases experience viral pneumonia that can progress to ARDS.

READ: Humanigen eyes evaluating lenzilumab in treating lung damage caused by coronavirus

Clinical trials of lenzilumab in patients with the virus will begin upon approval by relevant regulatory authorities, Humanigen said in a statement Friday.

"We have been conducting work on targeting GM-CSF to prevent or treat cytokine storm in a number of conditions. It now appears that this is a key trigger in ARDS associated with COVID-19 and we look forward to continuing to lead in the area of GM-CSF neutralization in this setting," Dr. Cameron Durrant, CEO at Humanigen, told investors.

He added: "We look forward to studying whether, with its excellent and proven safety and tolerability profile, lenzilumab may offer an alternative potential therapeutic solution in COVID-19 for already fragile, high-risk patients."

Lenzilumab is a late clinical-stage, monoclonal antibody targeting GM-CSF, a pro-inflammatory cytokine. The percentages of GM-CSF-expressing cells have been found to be significantly higher in the blood of ICU-admitted coronavirus patients compared with healthy controls.

Durrant said that while other anti-GM-CSF antibodies have been mainly focused on arthritic and other inflammatory conditions, the firm has been working on prevention of cytokine storm for nearly three years.

It considers lenzilumab, which has been developed over more than a decade, with its published data in prevention of cytokine storm in animal models and the ongoing ZUMA-19 clinical study in collaboration with Kite, to be the leading anti-GM-CSF monoclonal antibody.

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on 07/31/2020

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