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December 8, 2013
21:06 EDTKPTIKaryopharm presents data for Selinexor at ASH
Karyopharm Therapeutics announced the oral presentation of clinical data from an ongoing Phase 1 clinical trial of its lead oral SINE compound, Selinexor, KPT-330, in patients with relapsed and/or refractory non-Hodgkin lymphoma, NHL, and chronic lymphocytic leukemia, CLL, at the 2013 American Society of Hematology, ASH, Annual Meeting and Exposition being held December 7-10 in New Orleans.The data indicate that, as of December 4, first-in-class oral Selinexor showed preliminary evidence of anti-cancer activity as a single agent in the majority of heavily pretreated relapsed and/or refractory NHL and CLL patients in the study cohort with progressive disease on study entry. In these NHL and CLL patients, Selinexor induced low levels of severe adverse events, and several of these patients have remained on study with Selinexor as their only anti-cancer treatment for more than 6-12 months.
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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