Researchers at the Fred Hutchinson Cancer Research Center in Seattle say they have uncovered an FDA-approved drug that may be effective in combating the often-lethal cytokine storms that can plague those infected with COVID-19.
Just one problem: Because of the reluctance of the drug’s producer to supply it to the researchers, clinical trials in patients cannot proceed despite having funding to move forward.
Takeda told Fred Hutch that it doesn’t have the budget to produce additional doses of the treatment, researchers say. The company did not respond to a request for comment.
The therapy in question is ponatinib, known commercially as Iclusig, an oral medicine approved to treat several types of leukemia. The drug is under patent and carries a heavy price tag—$18,700 for a supply of 30 tablets—though COVID patients would probably need no more than 5-7 doses, said researcher Taran Gujral.
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In July of last year, after doctors discovered that 15 to 20% of COVID patients had cytokine storm, scientists at Fred Hutch began investigating 15 FDA-approved kinase inhibitors. A cytokine storm is a sudden release of inflammatory molecules in response to a threat and can cause respiratory failure and death. The storm can happen with sepsis and cancer patients after receiving some cell-based immunotherapies.
In the case of a COVID infection, a cytokine storm often requires a patient to go on a ventilator. The current treatment options are steroids and Gilead’s remdesivir.
In December of last year, researchers found through machine-learning that among the 15 FDA-approved treatments they reviewed, ponatinib showed the most potential to tame COVID-related cytokine storms. Preclinical tests in mice and cell lines have backed up the finding.
But an unwilling partner in Takeda has prevented Iclusig from being tested on people. Fred Hutch has even lined up donors to fund a trial, but Takeda has told the research group that it will not provide its prized drug, which it obtained for $5.2 billion in a 2017 buyout of Ariad.
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Gujral said that in his line of work, he’s gotten accustomed to disappointment as some discoveries never get a chance to play out. Securing venture capital to further treatments with no data or safety profile can be a tough sell, Gujral admits.
But in his mind, Iclusig should have been an easy sell.
“The most frustrating part of this is it’s an FDA-approved drug with a known safety profile that’s already being given to patients, and all we want to do is reposition it for another indication,” Gujral said. “No, I haven’t had this kind of frustration before.”