Karyopharm Therapeutics announces initiation of Phase I study of Selinexor in Singapore

Selinexor (KPT-330), is a first-in-class, oral selective inhibitors of nuclear export (SINE) compound that covalently inhibits exportin-1 (XPO1/CRM1), which leads to the accumulation of tumor suppressor proteins in the cell nucleus and the selective induction of apoptosis in cancer cells. This study is designed to determine the recommended Phase II dose and assess the safety and preliminary evidence of anti-cancer activity in Asian patients.

The study is being conducted by Drs David Tan and Goh Boon Cher at the National University Cancer Institute, Singapore (NCIS)/National University Hospital (NUH) in Singapore. Dr Tan is a consultant medical oncologist at the Department of Haematology-Oncology and Assistant Professor at the Yong Loo Lin School of Medicine, National University of Singapore (NUS). Dr Goh is Head of the Department of Haematology-Oncology and Deputy Director of the Cancer Science Institute of Singapore at the National University of Singapore.

Karyopharm founder, president and chief scientific officer Dr Sharon Shacham noted this Phase I study in Asian patients will allow the company to assess the tolerability and anti-tumor activity of Selinexor in patients with diverse tumor types that are under-represented in our current North American and European studies.

"We are particularly interested in the effects of Selinexor in malignancies such as gastric and hepatocellular carcinoma, which are poorly treated with available agents."

This Phase I dose escalation study will use a starting dose of 40mg/m2 orally twice each week. Selinexor is currently being evaluated in an ongoing Phase I dose escalation study in patients with advanced or metastatic solid tumors in North America and Europe at a dose of 85mg/m2 orally twice each week. Patients receive general supportive care, including appetite stimulating agents, in addition to oral Selinexor.