Ohio biotech CEO discusses headway on possible coronavirus treatment
Athersys CEO Gil Van Bokkelen told 'America's Newsroom' his company has been in active discussions with the FDA over the past few weeks about the design and implementation of a large-scale study focused specifically on COVID-19 patients
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Athersys, a Cleveland biotech company, says it is making headway on a possible stem cell treatment for the COVID-19 virus.
In an interview Wednesday on "America's Newsroom" with host Ed Henry, Athersys CEO Gil Van Bokkelen said that they had recently completed a study using a "double-blind randomized placebo-controlled trial" which evaluated multi-stem treatment on patients with Acute Respiratory Distress Syndrome or ARDS.
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"ARDS is the thing that COVID-19 is inducing in the patients that are becoming seriously and critically ill," he explained. "Essentially Acute Respiratory Distress Syndrome...is when the lungs become highly inflamed, they fill up with fluid, and that compromises the ability of the lungs and the body to absorb oxygen properly."
Currently, the sole approach physicians have for helping critical care patients is utilizing a ventilator to force oxygen into the lungs in an effort to keep them functional.
However, Van Bokkelen said the results of the Athersys study showed that when a single dose of multi-stem was administered to ARDS patients who were placed on a ventilator, they were able to dramatically reduce mortality and dramatically and rapidly improve pulmonary function.
"Patients were experiencing less time on ventilators. They were getting out of the ICU faster and, as we announced in January when we did a one-year follow-up, we saw that there was a dramatic improvement of quality of life for those patients that had been treated with multi-stem, relative to the patients that were receiving best available standard of care but only got placebo," he announced.
Based on those results, Van Bokkelen reported that the U.S. Food and Drug Administration (FDA) awarded the company fast-track designation for its ARDS program months before the outbreak.
"So, we've been in active discussions with the FDA over the past few weeks about the design and implementation of a large-scale study that will involve several hundred patients that will be focused specifically on COVID-19 patients that are experiencing [ARDS]," he added. "And, we're actually very hopeful that we're going to get that study up and running very quickly."
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Van Bokkelen told Henry that his message is that there are a lot of people focused clinically on trying to figure out the best way to approach the virus before patients become severely ill and need the aid of a ventilator.
"And, I think the interesting thing is that we may find that combination of things – early intervention that slows the progression of the disease and late-stage therapies like what we have – can really help turn the tide when patients become critically ill. Maybe those are the best approaches to take at the end of the day," he concluded. "Lots of things are being evaluated and I think we're trying to do it as expeditiously as possible."
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