A potentially groundbreaking novel coronavirus treatment being explored by Seattle’s Infectious Disease Research Institute has received FDA approval to start human trials.
That announcement came Thursday morning, two weeks after the institute landed a seven-figure funding deal with New Jersey-based biotech company Celularity to conduct the testing. The Seattle institute’s CEO, Dr. Corey Casper, said in an interview Thursday he hopes the testing can be expedited to begin this month.
“What we’re trying to do is follow the epidemic and figure out where the therapies will be most needed and figure out where we can open clinical trial sites at those places,” Casper said, adding he’s looking for “places that have the experience to open the study quickly, give the product safely to patients, and get the study done as safely and efficiently as possible.”
Casper said he’s sent evaluation proposals to 16 potential sites, including two in Washington state. He hopes to have the two sites here participate along with a handful of others on the East Coast — primarily in the greater New York and mid-Atlantic regions.
“The more sites that you have, the more complicated it is and more costly to administer,” Casper said. “So, our hope is that we can get this to a finite number.”
That process would usually take about six weeks, but given the urgency behind treating COVID-19, he’s hoping “to get someone in (for testing) this month and begin to get the therapy to the patients who need it.”
The proposed immunotherapy approach differs from previous antiviral treatments for COVID-19, the illness caused by the novel coronavirus.
Casper said antiviral treatments provoke reactions in COVID-19 patients that result in serious inflammation and often damage organs, like the lungs, as the body tries to ward off the infection. He said the “friendly fire” can cause more problems than it solves.
Instead, the immunotherapy approach would give patients back a “natural killer’’ cell — known as an NK-cell — used safely to treat lymphoma, leukemia and multiple myeloma. Reports say that COVID-19 patients lose a significant amount of these cells, so the treatment would reinfuse them and help enable the body to reduce inflammation while fighting off the illness.
Casper said about half the institute’s 55 employees will work on the trials. He said he should know within a couple of weeks whether patients are responding well to the treatment.
Unlike ongoing vaccine research, which take well over a year and possibly two years to complete, Casper hopes his trials can be done within 11 months.