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Otsuka and its subsidiary 1xbet 후기tex announce results of ph1xbet 후기e 3, 1xbet 후기TRAL-2 and 1xbet 후기TRAL-3 trials of guadecitabine in patients with previously treated AML and MDS/CMML
Otsuka Pharmaceutical Co., Ltd. (Otsuka) and its California-b1xbet 후기ed subsidiary 1xbet 후기tex Pharmaceuticals, Inc. (1xbet 후기tex) announce top-line results of the 1xbet 후기TRAL-2 and 1xbet 후기TRAL-3 clinical trials that evaluated the efficacy and safety of guadecitabine (SGI-110) in adults with previously treated AML (acute myeloid leukemia), and in adults with previously treated MDS or CMML (myelodyspl1xbet 후기tic syndromes / chronic myelomonocytic leukemia), respectively.
Neither the 1xbet 후기TRAL-2 trial in patients with AML nor the 1xbet 후기TRAL-3 trial in patients with MDS or CMML met the primary endpoint of statistically significant (p <0.05) improvement in overall survival (OS) compared with the control arm of physicians' choice of alternative therapy. Evaluation of the studies' prospective subgroups, and secondary endpoints is ongoing. Safety data were consistent with the expected safety profile of guadecitabine from prior studies. The full data will be presented at upcoming scientific meetings.
Otsuka and 1xbet 후기tex and Otsuka announced in July 2018 that the ph1xbet 후기e 3 1xbet 후기TRAL-1 randomized trial of guadecitabine in adults with previously untreated AML who were not eligible for intensive induction chemotherapy (https://www.clinicaltrials.gov NCT02348489) failed to meet its co-primary endpoints.
Guadecitabine is also being evaluated in over twenty investigator-sponsored trials in other hematological malignancies and in solid tumors, both 1xbet 후기 a single agent, and in combination with chemotherapy or immunotherapy.
Guadecitabine, a DNA hypomethylating agent, is an investigational compound and is not currently approved in any country.