GlycoMimetics, Inc., a firm that develops molecule drugs, has recently announced that biotech company Apollomics has dosed first patient in China in a Phase 3 clinical trial of its new relapsed or refractory acute myeloid leukemia (AML) drug, APL-106 (uproleselan injection).
The Phase 3 clinical trial is part of a randomized, placebo-controlled, double-blind, bridging study program that will assess the effectiveness of uproleselan combined with chemotherapy, compared to alone chemotherapy, for treating people suffering from relapsed/refractory AML in Chinese patients.
The trial is a part of a complete development program for Apollomics in China, including a continuing Phase 1 pharmacokinetic (PK) and tolerability study.
According to sources, around 140 adult patients with primary relapsed AML (first or second untreated relapse) or refractory AML, will be enrolled for trial and eligible to receive induction chemotherapy.
Harout Semerjian, GlycoMimetics Chief Executive Officer, said that dosing of the first patient in this Phase 3 clinical trial in Greater China is a noteworthy accomplishment for Apollomics. This achievement comes in line with the recent completion of enrollment in a pivotal Phase 3 trial studying uproleselan in addition to a standard chemotherapy routine in patients with relapsed/refractory AML.
The prime endpoint for the Phase 3 trial is overall existence. Secondary outcome procedures include the duration and rate of remission and if uproleselan could lower the rate of oral mucositis, a chemotherapy-related side effect.
Apollomics expects to perform this study at around 20 blood cancer clinical research centers across China.
About Apollomics Inc.
Apollomics Inc. is a pioneering biopharmaceutical company devoted to discovering and developing monotherapies and combination therapies of tumor-targeting and immuno-oncology agents. Apollomics has influential entities in California’s Foster City, and Hangzhou and Shanghai in China.
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