Press Releases / Notices

The company’s press releases sometimes carry information on pharmaceutical drugs and products in the pipeline. Under no circumstances is such information provided to promote or advertise these products or offer medical advice.

NEWS 2016

December 05, 2016 R & D

Nippon Shinyaku Co. Ltd. Announces Data Presentations at the 58th American Society of Hematology Annual Meeting

 Nippon Shinyaku Co. Ltd. today announced that data highlighting from Phase 2 portion of Phase1/2 study, open-label to assess the safety and efficacy of NS-018, an investigational oral selective JAK2 inhibitor, for the treatment of patients with myelofibrosis (MF), was presented at the 58th American Society of Hematology (ASH) Annual Meeting and Exposition, being held December 3rd in San Diego, CA. Only MF patients who received prior JAK2 inhibitor therapy, and been found to be intolerant, or refractory/relapsed from prior JAK2 inhibitor therapy, were enrolled into this Phase2 portion.

 This presentation is base on a result of Phase 1/2 study conducted overseas in which 300mg QD was administered to see its efficacy and safety in its Phase 2 portion. Twenty-nine (29) patients with MF who have been found to be intolerant, or refractory/relapsed from prior JAK2 inhibitor therapy, were enrolled in the Phase2 portion and twenty six (26) patients who had a chance to reach Week 24 (the first MRI/CT analysis time point) were utilized for the evaluation of efficacy.

 As a result, 16 (62%) of 26 patients achieved spleen volume reductions of ≥10% which is reported to be related to the improvement and survival.  9 (35%) of 26 patients achieved spleen volume reductions of ≥20% and 3 (12%) achieved a ≥35% reduction in spleen volume (All 3 patients maintained response for > 6 months). Spleen volume reductions were observed in 7 (78%) of 9 patients who are refractory/relapsed and were 10 (72%) of 14 patients who are intolerant from prior JAK2 inhibitor therapy.

 23 (88%) of 26 patients improved in TSS. 20 (77%) and 9 (35%) of 26 patients showed ≥25% reduction and ≥50% reduction in TSS respectively.

 NS-018 300 mg QD was generally well tolerated. The most common drug-related hematologic AEs were thrombocytopenia (14%) and anemia (21%); Anemia or thrombocytopenia did not worsen by >1 grade from baseline; hemoglobin levels were generally stable with NS-018 treatment. The most common drug-related non-hematologic AEs were nausea, diarrhea, and fatigue (each 17%), which was similar to that observed in the Phase 1 portion of the study. Grade 3/4 neurologic AEs, which were dose limiting in the Phase 1 study, were not observed in this Phase 2 portion. The activity and safety of NS-018 in patients intolerant of or relapsed/refractory to previous JAK2 inhibitor therapy suggests this agent may have utility in second-line treatment of MF.

"In this open label Phase 2 clinical trial in patients with advanced myelofibrosis that were previously treated with a JAK2 inhibitor, NS-018 has shown clinical benefit with formidable safety. This is challenging population of patients with MF, for which there is no good therapy available. We are looking forward to further developments on NS-018 for our MF patients" said Srdan Verstovsek, M.D., Ph.D., Professor, Department of Leukemia at the University of Texas MD Anderson Cancer Center and principal investigator for the Phase1/2 study of NS-018.

 

About the Phase 1/2 Studies

A Phase 1/2 study was open-label, dose-escalation, multi-center study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of orally administered NS-018 in patients with primary myelofibrosis (PMF), post-polycythemia vera (PV) myelofibrosis, or post-essential thrombocythemia (ET) myelofibrosis. For Phase 1 portion, the primary objective of the Phase 1 portion of the study is to evaluate the safety, tolerability, maximum tolerated dose (MTD), and clinically active dose of NS-018 when orally administered in patients with PMF, post-PV MF, or post-ET MF. The secondary objectives of the Phase 1 portion of the study are to determine plasma pharmacokinetics (PK), evaluate pharmacodynamic (PD) correlates, and evaluate preliminary efficacy of NS-018 in patients with PMF, post-PV MF, or post-ET MF. For Phase 2 portion, the primary objective of the Phase 2 portion of the study is to further evaluate the safety and efficacy of the selected dose(s) of NS-018 in patients with PMF, post-PV MF, or post-ET MF. The secondary objectives of the Phase 2 portion of the study are to further determine plasma PK and evaluate PD correlates of NS-018 in patients with PMF, post-PV MF, or post-ET MF. For the Phase 2 portion, MF patients must have received prior JAK2 inhibitor therapy, and been found to be intolerant, or refractory/relapsed from prior JAK2 inhibitor therapy, based on investigator assessment.

 

About Nippon Shinyaku Co., Ltd.

Nippon Shinyaku Co. Ltd., (pharmaceutical company in Japan) that develops innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases.