Louisville, KY, April 21, 2020 (GLOBE NEWSWIRE) -- 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.
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:
- Confirmed laboratory diagnosis of SARS-CoV2 by standard approved Reverse transcription polymerase chain reaction (RT-PCR) assay or equivalent approved testing.
- Currently hospitalized and consented within the first 48 hours of hospitalization.
- Informed consent provided as above (participants must be dosed with study drug within 12 hours of consent).
- Has symptoms of severe COVID-19 as demonstrated by:
- At least one of the following: fever, cough, sore throat, malaise, headache, muscle pain, shortness of breath at rest or with exertion, confusion, or symptoms of severe lower respiratory symptoms including dyspnea at rest or respiratory distress.
- AND Clinical signs indicative of lower respiratory infection with COVID-19, with at least one of the following: respiratory rate ≥ 30 breaths/minute (min), heart rate ≥ 125 /min, Oxygen saturation (SaO2) < 93% on room air or requires > 2 Liter (L)/minute oxygen by NC in order maintain SaO2 ≥ 93%, PaO2/FiO2 < 300 mm/hg.
- Concurrent anti-viral and/or anti-inflammatory agents (e.g., biologics, hydroxychloroquine) are permitted.
- Female patients of childbearing potential must have a negative serum pregnancy test at Screening. Female patients of childbearing potential and fertile male patients who are sexually active with a female of childbearing potential must use highly effective methods of contraception throughout the study and for 3 months following the last dose of study treatment
See full list of eligibility criteria.
More on the study
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.
Research at Norton Healthcare
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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About Norton Healthcare
For more than 130 years, Norton Healthcare’s faith heritage has guided its mission to provide quality health care to all those it serves. Today, Norton Healthcare is a leader in serving adult and pediatric patients from throughout Greater Louisville, Southern Indiana, the commonwealth of Kentucky and beyond. The hospital and health care system is Louisville’s fourth largest employer, providing care at more than 250 locations throughout Kentucky and Southern Indiana. The Louisville-based not-for-profit system includes five Louisville hospitals with 1,837 licensed beds; seven outpatient centers; 15 Norton Immediate Care Centers; more than 16,000 employees; more than 1,500 employed medical providers; and approximately 2,000 total physicians on its medical staff. Hospitals provide inpatient and outpatient general care as well as specialty care including heart, neuroscience, cancer, orthopedic, women’s and pediatric services. A strong research program provides access to clinical trials in a multitude of areas. More information about Norton Healthcare is available at NortonHealthcare.com.
About Karyopharm Therapeutics
Karyopharm Therapeutics Inc. (Nasdaq: KPTI) is an oncology-focused pharmaceutical company dedicated to the discovery, development, and commercialization of novel first-in-class drugs directed against nuclear export and related targets for the treatment of cancer and other major diseases. Karyopharm's Selective Inhibitor of Nuclear Export (SINE) compounds function by binding with and inhibiting the nuclear export protein XPO1 (or CRM1). Karyopharm’s lead compound, XPOVIO® (selinexor), received accelerated approval from the U.S. Food and Drug Administration (FDA) in July 2019 in combination with dexamethasone as a treatment for patients with heavily pretreated multiple myeloma. A Marketing Authorization Application for selinexor is also currently under review by the European Medicines Agency. A supplemental New Drug Application was recently accepted by the FDA seeking accelerated approval for selinexor as a new treatment for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). In addition to single-agent and combination activity against a variety of human cancers, SINE compounds have also shown biological activity in models of neurodegeneration, inflammation, autoimmune disease, certain viruses and wound-healing. Karyopharm has several investigational programs in clinical or preclinical development. For more information, please visit www.karyopharm.com.
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