• Recruitment Resumes Across All Selinexor Trials in Hematological Malignancies
• Timelines for Ongoing and Planned Studies Expected to Remain Materially Unchanged

Newton, MA (Press Release) – Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clin­i­cal-stage pharma­ceu­ti­cal com­pany, today announced that the U.S. Food and Drug Admin­istra­tion (FDA) Division of Hematology Products has lifted the partial clin­i­cal hold placed on the clin­i­cal trials for selinexor (KPT-330), enabling patient enroll­ment and dosing of new patients in the Company’s clin­i­cal trials of selinexor in hema­to­logical malig­nan­cies. The partial clin­i­cal hold was not the result of any patient death or any change in the safety profile of selinexor. Enrollment may now resume …

• 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
• Company ex­pec­ts timelines for both ongoing and planned studies to remain ma­teri­ally unchanged

Newton, MA (Press Release) – Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clin­i­cal-stage pharma­ceu­ti­cal com­pany, today announced that it has received written notice from the U.S. Food and Drug Admin­istra­tion (FDA) that its clin­i­cal trials for selinexor (KPT-330) have been placed on partial clin­i­cal hold. While the partial clin­i­cal hold remains in effect, patients with stable disease or better may remain on selinexor ther­apy. No new patients may be enrolled until the partial clin­i­cal hold is lifted.

The FDA has indicated that the partial …

The 2016 annual meeting of the American Society of Clinical Oncology (ASCO) is now history, but there's still plenty of news to report from the meeting.

In this edition of the Beacon's ASCO multiple myeloma updates, the focus is on pre­sen­ta­tions that took place the last two days of the ASCO meet­ing – this past Monday and Tuesday – and which con­cerned poten­tial new multiple myeloma ther­a­pies.

There was a block of oral pre­sen­ta­tions related to poten­tial new myeloma ther­a­pies that took place Tuesday morning, and all those pre­sen­ta­tions are covered in this article. …

A new year is upon us.  I hope it has started well for everybody, and that all had a great holiday season!

The last few weeks of 2014 were a hap­pen­ing time for the mul­ti­ple myeloma com­munity. The short span of time witnessed the pub­li­ca­tion of up­dated criteria for the diag­nosis of mul­ti­ple myeloma from the Inter­na­tional Myeloma Work­ing Group (IMWG). In addi­tion, the 56^th annual meeting of the American Society of He­ma­tol­ogy (ASH) took place in San Francisco, with literally hundreds of myeloma-related oral and poster pre­sen­ta­tions.

Therefore, it is again …

Six Data Presentations at the European Hematology Association's 19th Congress

Natick, Massachusetts (Press Release) - Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clin­i­cal-stage pharma­ceu­tical com­pany, today announced initial Phase 1 data from patients with multiple myeloma treated with Karyopharm's lead selective inhibitor of nuclear export (SINE), Selinexor (KPT-330), in com­bi­na­tion with "low-dose" (20 mg twice weekly) dexa­meth­a­sone. Among eight patients, the best responses were one stringent com­plete response (sCR), three partial responses (PRs), two minor responses (MRs), one pro­gressive disease and one non-evaluable. Accordingly, the clin­i­cal benefit response rate (sCR+PR+MR) is 75% and the over­all response rate (sCR+PR) is 50%. These new results will be …