In light of recent events, Humanigen recently announced that the FDA had approved the administration of Lenzilumab for COVID-19 patients under individual patient emergency IND (Investigational New Drug) applications. These patients should be within Humanigen's compassionate use program.
The company is fast-tracking its plans to conduct its Phase III, randomized, double-blinded, controlled, clinical trial with Lenzilumab across multiple testing centers. They plan on using the antibody for the prevention of ARDS (Acute Respiratory Distress Syndrome), which is the leading cause of death for hospitalized patients with COVID-19.
COVID-19 has become a global pandemic, with over 940,000 confirmed cases worldwide and over 47,000 deaths reported as of writing. The nature of the disease attacks the respiratory systems of patients with the most severe cases making them experience severe viral Pneumonia, which progresses to Acute Respiratory Distress Syndrome (ARDS) and eventually leading to death.
Acute Respiratory Distress Syndrome (ARDS) is usually characterized by hypoxia or a lack of oxygen to the tissue. This life-threatening disease is an acute, inflammatory lung injury that stiffens the lungs, which in turn reduces the amount of air that passes through the lungs, which is why patients with COVID-19 greatly require mechanical ventilators to help them breathe, as ARDS continues to threaten their lives.
Dr. Cameron Durrant, the CEO of Humanigen, said in a recent interview that they were gratified to be able to offer compassionate use of Lenzilumab for patients with COVID-19. Humanigen was the pioneer of GM-CSF neutralization or treating the so-called cytokine storm, unlike other approaches towards the neutralization Humanigen has already conducted Phase I and Phase II of their studies. The study included patients with severe respiratory conditions and yielded excellent results.
As per Dr. Cameron Durrant, Lenzilumab, Lenzilumab has an excellent safety and tolerability profile without any risks of serious side effects as it has not been associated with any adverse effects whatsoever. Previous studies included patients who were immunosuppressed and patients with severe asthmatic problems. They have studied the prevention of cytokine storm for nearly three years, yielding great results in their tests. This is a field that Humanigen thrives in, it is their area of expertise, and they have published multiple papers and studies in this field extensively. Multiple leading companies in the field are backing up Humanigen's claims and reinforcing their studies. Humanigen has filed extensive Intellectual Property patents on GM-CSF neutralization across a wide range of therapeutic areas, including COVID-19.
David J Kovacs, the recently appointed Head of Policy for Humanigen commented:
"At the very least, our treatment will put a dent in this pandemic. We must rely on science rather than speculation, and we feel strongly we have the science.
We are approved by the FDA to administer our treatment for compassionate use, and we are a U.S. based Company. Our treatment seems like one of the better, if not the best options in the market at the moment.
The Company's only request is for our government and others to do whatever they can to support us during these times because we need all the help we can get. Good people such as Dillon Kivo, who donated his public relations services, is one great example of help."
The battle against this global pandemic is constantly escalating, with cases rising daily and government's scurrying to contain the spread of the virus, Humanigen stands strong amid the crisis and rapidly offers a solution to reduce the deaths that the virus could cause. They are leading the charge into mitigating the negative effects of the virus and saving the world in the process.
For more information contact David at dkovacs@humanigen.com
SOURCE: Humanigen, Inc
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https://www.accesswire.com/583937/Humanigen-is-Leading-The-Charge-Into-Reducing-COVID-19-Related-Deaths
