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news.US-based pharmaceutical firm Karyopharm Therapeutics has started Phase II trial of its new oral Selective Inhibitor of Nuclear Export / SINE(TM) compound Selinexor (KPT-330) in patients with Richter's transformation (SIRRT) that is relapsed after or refractory to chemotherapy.
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Selinexor works by inhibiting the nuclear export protein XPO1, leading to the accumulation of tumor suppressor proteins in the cell nucleus, which subsequently reinitiates and amplifies their tumor suppressor function.
The single arm, open-label, multi-center Phase II trial will enroll around 50 patients in about 35 sites across the world.
Expected to take two years to complete, the trial is designed to assess the safety and efficacy of Selinexor given orally at 60mg/m2 twice weekly.
Primary endpoint of the trial is overall response rate, which was designed based on data from the ongoing Phase I trial of Selinexor in patients with advanced hematologic malignancies, including Richter’s.
Karyopharm president and chief scientific officer Sharon Shacham said: "Richter’s Transformation is a rare condition in which chronic lymphocytic leukemia transforms into a fast-growing type of aggressive lymphoma.
"Treatment options for these patients are limited and prognosis is generally poor, with median survival less than 10 months from diagnosis.
"Anti-cancer activity observed to in patients with Richter’s Transformation enrolled in our Phase 1 Selinexor study in advanced hematologic malignancies gives us encouragement that this registration-direction will support Selinexor as a treatment option for this group of patients."