LVHN Among Early Participants to Test Cancer Drug as COVID-19 Treatment
Study is among several currently underway or being planned at LVHN
Lehigh Valley Health Network (LVHN) is among the first participants in an international clinical trial to test the effectiveness of the drug selinexor to treat COVID-19.
The placebo-controlled study looks at selinexor, marketed under the brand name XPOVIO, as a potential antiviral and anti-inflammatory treatment for COVID-19. It is manufactured by Karyopharm Therapeutics, Inc. headquartered in Massachusetts.
Selinexor is currently approved at higher doses by the Food and Drug Administration (FDA) as a treatment for patients with relapsed or refractory multiple myeloma. Selinexor has been extensively tested in clinical trials across numerous cancer indications worldwide since 2012.
Selinexor is what’s known as a selective inhibitor of nuclear transport, or SINE, in cells. It’s been shown that COVID-19’s ability to replicate is impaired when nuclear transport is blocked. Animal models suggest some significant reduction in viral replication.
The study will assess the effectiveness and safety of 20mg of selinexor given orally to patients in the hospital three times a week for two weeks. Patients tolerating therapy well and experiencing clinical benefit may be eligible to have the treatment extended to four weeks if needed according to Marcelo Gareca, MD, an infectious disease specialist and the principal investigator of the study at LVHN.
Karyopharm announced Monday, April 20, the dosing of the first patient in a randomized Phase 2 clinical study evaluating low dose oral Selinexor in hospitalized patients with severe COVID-19. The global study is expected to enroll approximately 230 patients at clinical sites in the US, Europe, and Israel. LVHN currently has four patients enrolled in the trial and a fifth receiving the drug for compassionate use, meaning the patient is being treated outside the formal clinical trial because he or she could benefit from its use.
Timothy Friel, MD, LVHN’s Chair of the Department of Medicine and an infectious diseases specialist, says the health network is involved in several studies to determine the types of treatment that could be effective against COVID-19. In one of those, patients with severe COVID-19 infections receive plasma donated from other patients who have recovered from COVID-19. This plasma, called “convalescent plasma,” contains antibodies produced by the donor’s immune system to fight the virus. It is hoped that this treatment will provide a boost to the immune system of the sick patient and potentially speed the recovery process.
Miller-Keystone Blood Center and American Red Cross are strongly encouraging plasma donations from recovered COVID-19 patients. Plasma (the liquid part of our blood) cannot be manufactured by a pharmaceutical company. Therefore, we are dependent upon donations from recovered patients to ensure that we have a continued supply of this investigational therapy.
“At the present time, no medications have been proven to be effective in treating this illness,” Friel said. “We are eager to offer any potential interventions like selinexor and convalescent plasma that might make a difference for our critically-ill COVID-19 patients.”
Gareca said among several other studies LVHN would hope to be able to enroll hospitalized patients in soon is one involving the use of the rheumatoid arthritis drug tocilizumab. Tocilizumab is a medication that blocks IL-6, a cytokine actively involved in the body’s immune response to infection.
“IL-6 seems to be linked to the significant inflammatory response that many of the sickest COVID-19 patients experience during their illness,” Gareca said. “By blocking the excessive release of IL-6, we hope to reduce the “cytokine storm” reported in many patients that significantly impairs many normal body functions and can contribute to some of the exaggerated factors like low blood pressure, excessive inflammation and increased blood clotting in patients with COVID-19.”
Karyopharm has a sufficient supply of Selinexor for current and expected patients with multiple myeloma, for ongoing clinical trials in patients with various cancers, as well as for this study in patients with COVID-19.
Lehigh Valley Health Network includes eight hospital campuses, three in Allentown, one in Bethlehem, one in East Stroudsburg, one in Hazleton and two in Pottsville, Pa.; Coordinated Health, which includes two hospital campuses, nearly two dozen multispecialty locations including ambulatory surgery centers and orthopedic injury centers in northeastern Pennsylvania and western New Jersey; 26 health centers; numerous primary and specialty care physician practices; 22 ExpressCARE including the area’s only Children’s ExpressCARE; pharmacy, imaging, home health, rehabilitation, and lab services; and preferred provider services through Valley Preferred. Specialty care includes trauma care for adults and children, burn care at the Regional Burn Center, kidney and pancreas transplants; perinatal/neonatal, cardiac, cancer, orthopedics, neurology, complex neurosurgery capabilities including national certification as a Comprehensive Stroke Center, and robotic surgery in 10 specialties. Lehigh Valley Cancer Institute, Lehigh Valley Heart Institute, and Lehigh Valley Institute for Surgical Excellence physicians provide the most advanced treatments. The Lehigh Valley Cancer Institute is a member of the Memorial Sloan Kettering (MSK) Cancer Alliance, an initiative that helps community providers improve the quality of cancer care and offers access to MSK clinical trials. Lehigh Valley Reilly Children’s Hospital, the community’s only children’s hospital, provides care in more than 30 specialties and general pediatrics. Lehigh Valley Hospital–Cedar Crest is the region’s only hospital nationally ranked by U.S. News & World Report for orthopedics and has been recognized among Pennsylvania’s top five hospitals for six consecutive years. Lehigh Valley Hospital–Cedar Crest, Lehigh Valley Hospital–17th Street and Lehigh Valley Hospital–Muhlenberg are the region’s only Magnet® hospitals for nursing excellence. Additional information is available by visiting LVHN.org, or following us on Facebook, Twitter, LinkedIn, and Instagram.