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Karyopharm Announces Selinexor Clinical Data to be Presented at the International Society for Influenza and Other Respiratory Virus Diseases Antiviral Group Virtual Conference on Therapeutics for COVID-19
− Encouraging Anti-Viral and Anti-Inflammatory Activity Demonstrated in a Subset of Patients in a Study of Low Dose Selinexor in Hospitalized Patients with
About this update from Karyopharm Therapeutics Inc.
[{"type":"text","content":"− Encouraging Anti-Viral and Anti-Inflammatory Activity Demonstrated in a Subset of Patients in a Study of Low Dose Selinexor in Hospitalized Patients with Severe COVID-19 −\n − A Case Report From a COVID-19 Patient Treated with Selinexor Now Also Published in the Annals of Case Reports -\n\n\n NEWTON, Mass., Oct. 6, 2020 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced an oral presentation at the International Society for Influenza and Other Respiratory Virus Diseases Antiviral Group (ISIRV-AVG) Virtual Conference on Therapeutics for COVID-19 taking place from October 6 - 8, 2020. The presentation will feature data from a Phase 2 clinical study evaluating low dose oral selinexor in hospitalized patients with severe COVID-19 (NCT04349098). \nWhile an interim analysis indicated that the trial was unlikely to meet its pre-specified primary endpoint across the entire patient population studied, and has since been discontinued, the results demonstrated encouraging anti-viral and anti-inflammatory activity in an important subset of treated patients. The randomized, multi-center, placebo-controlled Phase 2 study was designed to assess the activity and safety of 20mg of selinexor given orally three times a week for two weeks, a dosing level significantly lower than the U.S. Food and Drug Administration (FDA) approved dose of selinexor, marketed as XPOVIO®, to treat patients with relapsed or refractory multiple myeloma or relapsed or refractory diffuse large B-cell lymphoma. \nA post-hoc analysis of 66 patients with either baseline serum lactate dehydrogenase (LDH) ≤370 U/L or D-dimer ≤600 mcg/L FEU (Low LDH/DD) showed that treatment with selinexor (n=38) compared to placebo (n=28) was associated with a significantly higher percentage of patients discharged by Day 14 (78.9% vs 57.1%; p=0.029) with a trend towards superior ≥2-point improvement in the Ordinal Scale (OSI-2) on Day 14 (78.9% vs 64.3%; p=0.095). Additionally, a positive trend was observed in patients treated with selinexor to convert to a negative COVID-19 PCR test as compared to placebo (42.1% vs 28.6%; p=0.13) and a significant reduction in IL1-RA, IL-6, IL-7, IP-10, and TNF-a levels, measurements of inflammation, was also seen within eight days of selinexor treatment (...