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January 7, 2014
08:50 EDTKPTIKaryopharm submits NADA for Verdinexor to FDA CVM
Karyopharm Therapeutics announced that it has submitted to the FDA Center for Veterinary Medicine, or CVM, the effectiveness and safety technical sections under a New Animal Drug Application, or NADA, for Verdinexor for the treatment of dogs with newly diagnosed or first relapsed non-Hodgkin lymphoma, or NHL. Verdinexor has received a designation from the CVM's Office of Minor Use and Minor Species, or MUMS, for the treatment of companion dogs with lymphoma, and the required portions of the NADA are being submitted initially under the CVM's MUMS guidelines.
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November 24, 2014
08:05 EDTKPTIKaryopharm presents data on oncology pipeline
Karyopharm Therapeutics announced the presentation of data describing its oncology product candidates at the 26th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics in Barcelona, Spain held November 18-21. Data for its lead product candidate, Selinexor, a first-in-class, oral Selective Inhibitor of Nuclear Export / SINE compound, described its synergistic anti-tumor activity in combination with DNA damage-inducing treatments such as anthracyclines or radiation in a non-small cell lung cancer mouse model. In addition, a description of a newly developed pharmacodynamic assay designed to evaluate direct Selinexor binding to XPO1 in patients was presented. Finally, data describing the identification of novel mechanism PAK4 allosteric modulators and their ability to inhibit tumor cell growth and induce apoptosis were presented. In a poster entitled "Selective Inhibitors of Nuclear Export (SINE™) Block the Expression of DNA Damage Repair Proteins and Sensitize Cancer Cells to DNA Damage Inducing Agents," data demonstrated that Selinexor inhibited the DNA repair mechanisms in solid and hematological cancer cell lines and therefore, preventing the cancer cell recovery following treatment with agents that cause DNA damage, leading to increased cancer cell death.

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