Humanigen Inc (OTCQB:HGEN) announced Wednesday that the first coronavirus (COVID-19) patient has been dosed in a Phase 3 trial of its drug lenzilumab.
Lenzilumab is a proprietary anti-human granulocyte macrophage-colony stimulating factor (GM-CSF), which the company believes can potentially prevent serious outcomes in hospitalized patients with COVID-19 pneumonia.
Shares in New York gained 8.3% to $0.91 on the day.
The now ongoing trial is the first randomized, double-blind, placebo-controlled, multi-center, Phase 3 study of an anti-GM-CSF conducted in the US, the company said.
"We are working with some of the top centers and clinicians in the US, alongside our contract research organization partner, CTI, to advance lenzilumab through Phase III with the intent to prevent serious and potentially fatal outcomes in high-risk patients who are hospitalized with COVID-19,” Humaigen CEO Cameron Durrant said in a statement.
“We are encouraged by our experiences in the compassionate use patients treated with lenzilumab and look forward to working with stakeholders to share these data."
Lenzilumab is designed to mitigate what's known as the cytokine storm, an overactive immune response to the coronavirus that can cause inflammation and in the lungs and fluid build-up, which can lead to respiratory issues and be contaminated by secondary bacterial pneumonia.
"GM-CSF has been shown to be earlier in the cascade, or ‘upstream', of multiple other cytokines, such as IL-6, IL-1 and TNF-α in cytokine storm,” Durrant added. “Excess GM-CSF production is thought to be the key initial trigger in certain disease states that may lead to significant ‘downstream' consequences, as these and other cytokines become elevated.
“Therefore, the possibility exists that cytokine storm may be prevented or minimized by neutralizing GM-CSF. As the only company working on prevention of cytokine storm through GM-CSF neutralization for nearly three years, we have multiple accepted publications in this field, substantial safety data, including in patients with severe respiratory disease, and have filed extensive IP."
CTI Clinical Trial and Consulting Services is a global, full-service contract research organization (CRO), delivering a complete spectrum of clinical trial and consulting services. It has clinical trial experience across six continents and partners with research sites, patients, and sponsors to fulfil unmet medical needs.
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