Karyopharm starts clinical trial of oral selinexor in advanced liposarcoma

Selinexor is the company’s oral selective inhibitor of Nuclear Export (SINE) compound. It binds to and inhibits the nuclear export protein XPO1, resulting in the accumulation of tumor suppressor proteins in the cell nucleus.

Under the multi-center, randomized, double-blind, placebo-controlled trial, the company will randomize patients to receive either 60mg of selinexor or placebo given twice weekly per six week cycle until progression or intolerability.

Karyopharm plans to enroll fifty patients in the phase 2 part of the trial. The enrollment may increase in the phase 3 portion after an interim analysis.

Top-line data from the phase 2 portion of the trial are anticipated early next year.

Karyopharm Therapeutics president and chief scientific officer Sharon Shacham said: "We believe selinexor offers the potential to provide a still deeply underserved liposarcoma patient population with a new therapeutic option.

"We look forward to the advancement of this study and to the launch of additional randomized studies of selinexor in solid tumors, as well as hematologic malignancies, where high unmet medical needs persist."

The company has treated more than 1,400 patients with selinexor in phase 1 and phase 2 clinical trials in advanced hematologic malignancies and solid tumors.

Selinexor is also being evaluated in several later-phase clinical trials, including one in older patients with acute myeloid leukemia, one in patients with Richter’s transformation, one in patients with diffuse large B-cell lymphoma and a single-arm trial of selinexor and lose-dose dexamethasone in patients with multiple myeloma.