ARTICLE | Clinical News

Karyopharm sinks on sepsis reports

August 11, 2015 1:54 AM UTC

Karyopharm Therapeutics Inc. (NASDAQ:KPTI) tumbled $8.61 (39%) to $13.44 on Monday after disclosing in its 2Q15 earnings that treatment with 55 mg/m2 selinexor ( KPT-330) was associated with a greater incidence of sepsis vs. the control arm in the Phase II SOPRA trial to treat acute myelogenous leukemia (AML), as well as in "maturing data" from an ongoing Phase I trial.

SOPRA is evaluating overall survival (OS) in elderly AML patients. Karyopharm reported that seven of 70 patients receiving selinexor developed sepsis, including one who developed it twice, compared to two cases in two of 30 patients in the control arm. Karyopharm said the incidence was greater than expected. The company amended the study protocol to reduce the dose by about 35% to a fixed 60 mg, which translates to about 35 mg/m2. ...