A drug used to treat HIV and cancer patients has shown success in treating some of the most severe COVID-19 patients, and just got cleared by the FDA to start a phase 2 clinical trial. Much of the work behind the drug is happening right in Washington State.
The drug was developed by a company called CytoDyn in Vancouver, Washington.
It’s manufactured by a company in Bothell, AGC Biologics, which makes a special molecule that’s the key ingredient in the drug.
Scientists at CytoDyn figured out it could work to treat COVID-19 and the first severely sick patients who’ve tried it have shown improvement.
The drug is called leronlimab and comes in a vial and is a two-shot per week dose, over two weeks.
It’s being tried on 10 of the most critically ill COVID-19 patients at Montefiore Medical Center in New York City, the University Hospital for Albert Einstein College of Medicine.
The patients are on ventilators and some are barely conscious.
“The first four patients who were intubated, two were extubated. One of them self-extubated, and became alert,” said Nader Pourhassan, the CEO of CytoDyn.
Now the two patients are out of the ICU.
Pourhassan said when he heard the results he had to stop what he was doing.
“And cried for about five minutes. It was very, very emotional,” Pourhassan said.
He said studies show that in the U.S., 85 percent of COVID-19 patients who end up needing ventilators will die.
But the patients who’ve gotten shots of this drug have shown strong results.
“All eight patients we’ve analyzed so far -- the first eight patients -- saw immunological benefits. The FDA immediately allowed us to have a phase two randomized trial. We are initiating that today,” Pourhassan said on Friday.
He said the results were even seen in COVID patients who only got the shots three days, though it takes two weeks for full effect.
The drug is already used for treating HIV and breast cancer. AGC Biologics has been manufacturing the key molecule for almost four years, and says it’s ready to ramp up production to treat coronavirus patients if needed.
“Our urgency level couldn’t be higher. It’s every day, seven days a week,” said Mark Womack, the chief business officer of AGC Biologics.
For people sick with COVID, when the virus reaches your lungs, your immune system starts attacking there -- causing more inflammation, which can stimulate the immune system to attack the lungs further.
It’s a vicious cycle called a “cytokine storm” and your lungs can fill with fluid, and then you can’t breathe.
The drug leronlimab basically boosts your immune system and calms the acute inflammation in the lungs that prevents people from breathing.
CytoDyn said FDA also cleared them to try treating less seriously ill patients to see if the drug will stop the virus from reaching advanced stages.
“We’re hoping we can save millions of lives,” Pourhassan said.
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