Karyopharm Initiates Registration-Directed Clinical Study Of Selinexor (KPT-330) In Patients With Richter's Transformation

Karyopharm Therapeutics Inc. KPTI, a clinical-stage pharmaceutical company, today announced the initiation of its Phase 2 study of Selinexor (KPT-330) in patients with Richter's transformation (SIRRT) that is relapsed after or refractory to chemotherapy. This multi-center study of Selinexor, one of the company's novel, oral Selective Inhibitor of Nuclear Export / SINE™ compounds, will enroll approximately 50 patients in approximately 35 sites worldwide. This single arm, open-label, Phase 2 study will evaluate the safety and efficacy of Selinexor given orally at 60 mg/m2 twice weekly. Overall response rate is the primary endpoint of this study, which was designed based on data from the ongoing Phase 1 study of Selinexor in patients with advanced hematologic malignancies, including Richter's. This study is expected to take 2 years to complete. "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," said Sharon Shacham, PhD, MBA, President and Chief Scientific Officer of Karyopharm. "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." "The initiation of our second registration-directed clinical study with Selinexor represents additional progress toward our goal of accelerating drug development for patients with severe hematologic indications with high unmet medical need," said Michael G. Kauffman, MD, PhD, Chief Executive Officer of Karyopharm. "In addition, we are continuing development efforts with Selinexor, both as a single agent and in combination with current standard-of-care therapy, in a number of other hematologic and solid tumor indications."