Story by: Norton Healthcare on April 20, 2020
A COVID-19 patient at Norton Healthcare is the first in the world to participate in a randomized Phase 2 clinical study using low-dose selinexor. This oral drug, manufactured by Karyopharm Therapeutics Inc. and marketed as XPOVIO, is currently approved at higher doses by the U.S. Food and Drug Administration (FDA) as a treatment for cancer patients with relapsed or refractory multiple myeloma. This is just one therapy being studied at Norton Healthcare to help patients recover from COVID-19.
This clinical trial is studying the antiviral and anti-inflammatory properties of selinexor in patients with severe COVID-19. At Norton Healthcare, the study is being led by Don A. Stevens, M.D., a hematologist/oncologist with Norton Cancer Institute.
“We are examining how we can decrease the ability of the virus to replicate or reproduce in our patients’ cells,” Dr. Stevens said. “We also want to see how it can decrease the release of a biochemical responsible for inflammation that in some cases can cause organ damage.”
Norton Healthcare is one of 40 locations internationally to participate in this clinical trial.
Related: What COVID-19 and the vaccines mean for cancer patients and survivors
To be eligible, patients must be hospitalized with a laboratory-confirmed case of SARS-CoV-2 (the virus that causes COVID-19) and consent to participation within 48 hours of hospitalization.
Patients must meet additional criteria:
See full list of eligibility criteria.
Selinexor is an oral selective inhibitor of nuclear export (SINE) compound that blocks the cellular protein XPO1, which may be involved in both the replication of SARS-CoV-2 and in the inflammatory response to the virus.
The randomized, multicenter, placebo-controlled Phase 2 study (XPORT-CoV-1001/NCT04349098) of low-dose selinexor is designed to assess the activity and safety of 20 milligrams of selinexor given orally three times a week for two weeks. Patients tolerating therapy well and experiencing clinical benefit may be eligible to continue treatment for an additional two weeks at the discretion of the treating physician.
Norton Healthcare’s clinical trials program is the most robust program in the region and has been instrumental in the development of many drugs and medical devices. Norton Healthcare clinical trials include emerging treatments for cancer, cardiovascular issues, neurological conditions, orthopedic conditions, maternal-fetal medicine and many more.
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