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June 13, 2014
05:17 EDTKPTIKaryopharm announces first combination data of Selinexor Phase 1 trial
Karyopharm Therapeutics announced initial Phase 1 data from patients with multiple myeloma treated with Karyopharm's lead selective inhibitor of nuclear export, or SINE, Selinexor, in combination with "low-dose" dexamethasone. Among eight patients, the best responses were one stringent complete response, or sCR, three partial responses, or PRs, two minor responses, or MRs, one progressive disease and one non-evaluable. Accordingly, the clinical benefit response rate is 75% and the overall response rate. Adverse events in patients receiving single-agent Selinexor were generally low-grade, consistent with events observed in patients with other hematological malignancies and responsive to standard supportive care. Compared with Selinexor given alone, fewer adverse events in patients receiving Selinexor in combination with dexamethasone were reported, consistent with dexamethasone's reduction in Selinexor's main side effects of nausea, anorexia, and fatigue.
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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December 7, 2014
14:48 EDTKPTIKaryopharm to hold an investor dinner and a clinical data presentation
Investor Dinner and a clinical data presentation being held in conjunction with the American Society of Hematology's 56th Annual Meeting in San Francisco on December 8 at 10:15 pm.

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