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BRIEF-Karyopharm to pause enrollment in Selinexor trials
March 11, 2017 / 1:26 AM / 9 months ago

BRIEF-Karyopharm to pause enrollment in Selinexor trials

March 11 (Reuters) - Karyopharm Therapeutics Inc

* Karyopharm announces partial clinical hold to pause enrollment in Selinexor trials

* All currently enrolled patients with stable disease or better can continue receiving selinexor

* Company has amended investigator’s brochure and informed consent documents as requested by fda

* Expects timelines for both ongoing and planned studies to remain materially unchanged

* Karyopharm Therapeutics- received written notice from u.s. Fda that its clinical trials for selinexor have been placed on partial clinical hold

* Karyopharm Therapeutics- fda has indicated partial clinical hold is due to incomplete information in existing version of investigator’s brochure

* Karyopharm Therapeutics - partial clinical hold is not result of any patient death or any new information regarding safety profile of selinexor

* Karyopharm Therapeutics inc - as of march 10, co had provided all requested materials to fda believed to be required to lift partial clinical hold

* Karyopharm Therapeutics says co believes its previously disclosed enrollment rates and timelines for its ongoing trials will remain materially unchanged Source text for Eikon: Further company coverage:

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