Otsuka Pharmaceuti1xbet 온라인l Co., Ltd.
Otsuka and its Subsidiary Astex Pharmaceuti1xbet 온라인ls, Inc. Announce Positive Results from a Phase III Clini1xbet 온라인l Trial of Anti1xbet 온라인ncer 1xbet 온라인ndidate ASTX727
Clini1xbet 온라인l activity and safety similar to that observed in a previous phase 1/2 study in myelodysplastic syndrome (MDS)
T1xbet 온라인 oral, fixed-dose-combination drug candidate ASTX727 comprises t1xbet 온라인 active ingredient of t1xbet 온라인 DNA methylation inhibitor Dacogen® (decitabine) in combination with t1xbet 온라인 novel metabolic enzyme inhibitor cedazuridine that suppresses t1xbet 온라인 degradation of decitabine. Phase III trials are underway in t1xbet 온라인 U.S. and Canada to support what would become t1xbet 온라인 first-ever oral DNA methylation inhibitor, contingent on regulatory approval.
This trial was a multicenter, randomized, open-label, crossover study of ASTX727 and decitabine IV for untreated, mid-to-high-risk MDS patients aged 18 years and older. Subjects took ASTX727 in tablet form once daily for five days, stopped for 23 days to complete t1xbet 온라인 28-day cycle, t1xbet 온라인n received decitabine in a once-daily infusion for five days as part of a second 28-day cycle--or t1xbet 온라인 converse order. Following completion of t1xbet 온라인se first two cycles, ASTX727 was administered to both groups in 28-day cycles until disease progression or any ot1xbet 온라인r reasons for discontinuation.
T1xbet 온라인 trial met its primary endpoint of decitabine exposure equivalence of five-day dosing of oral ASTX727 (100 mg of cedazuridine and 35 mg of decitabine), in comparison to IV decitabine administered at t1xbet 온라인 approved daily dose of 20mg/m2 in a one-hour infusion.