Positive Top-Line Phase 2b STORM Results Reported, with Plans for Development Path of Selexinor for the Treatment of Multiple Myeloma

Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, announced the initiation of the STORM study (Selinexor Treatment of Refractory Myeloma) on September 6, 2016. STORM is a multi-center, single-arm Phase 2 study of selinexor (KPT-330) in heavily-pretreated patients with quad-refractory multiple myeloma. Selinexor, the company's lead, novel, oral Selective Inhibitor of Nuclear Export / SINE ™ compound, will be evaluated in combination with low-dose dexamethasone in multiple myeloma patients whose disease was refractory to treatment with bortezomib (Velcade®), lenalidomide (Revlimid®), carfilzomib (Kyprolis®) and pomalidomide (Pomalyst®). The first cohort will enroll approximately 80 patients at about 30 sites, primarily inthe United States, with ~25% of the patients also having received treatment with an anti-CD38 monoclonal antibody such as daratumumab. Depending on the results from this initial cohort, the trial may be expanded to include additional patients. Data from an expanded trial may support an accelerated approval of selinexor in refractory multiple myeloma. Selinexor received orphan drug designation from theU.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for multiple myeloma.
Source: International Myeloma Foundation - Category: Hematology Source Type: news