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June 24, 2014
08:48 EDTKPTIKaryopharm initiates study of Selinexor in older AML patients
Karyopharm Therapeutics announced the initiation of its Phase 2 study of Selinexor in patients 60 years of age or older with relapsed or refractory acute myeloid leukemia, or AML, who are ineligible for intensive chemotherapy and/or transplantation. This Selinexor in Older Patients with Relapsed/Refractory AML, or SOPRA, study is a randomized trial of Selinexor, the company's novel oral Selective Inhibitor of Nuclear Export compound, versus physician's choice, and will be conducted at approximately 40 sites worldwide including sites in the United States, Canada, Europe and Israel.
News For KPTI From The Last 14 Days
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December 15, 2014
10:18 EDTKPTIKaryopharm management to meet with JMP Securities
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December 12, 2014
08:16 EDTKPTIKaryopharm sell-off overdone, says JMP Securities
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December 11, 2014
16:30 EDTKPTIOn The Fly: Closing Wrap
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08:10 EDTKPTIKaryopharm initiates third registration-directed clinical trial of Selinexor
Karyopharm Therapeutics announced the initiation of the SADAL study, or Selinexor and Dexamethasone in Aggressive Lymphoma, a registration-directed, Phase 2b study of Selinexor, or KPT-330, in patients with relapsed/refractory diffuse large B-cell lymphoma, or DLBCL. This randomized, multi-center study of Selinexor, one of the company's novel, oral Selective Inhibitor of Nuclear Export/SINE compounds, is being evaluated as a single agent in combination with dexamethasone for supportive care and is expected to enroll approximately 200 patients in approximately 90 sites worldwide. Karyopharm has received Orphan Drug Designation from the FDA and European Medicines Agency, or EMA, for Selinexor for the treatment of patients with DLBCL. This open-label Phase 2b study will evaluate the safety and efficacy of high dose versus mid dose Selinexor in combination with low dose dexamethasone for supportive care, each given orally to approximately 200 patients with relapsed/refractory DLBCL. Overall response rate, or ORR, is the primary endpoint. The study is expected to take approximately two years to complete and is intended to support accelerated regulatory approval. This study was designed in consultation with the FDA and on the basis of data from Karyopharm's ongoing Phase 1 study of Selinexor in patients with advanced hematologic malignancies.
December 9, 2014
10:19 EDTKPTIHigh option volume stocks
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10:08 EDTKPTIHigh option volume stocks
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December 8, 2014
13:03 EDTKPTIKaryopharm reports positive combination data for Selinexor
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