Apollomics Inc. doses first patient in phase III clinical trial in China of GlycoMimetics’ uproleselan.
Apollomics’ Phase III trial with APL 106 is part of the overall development program for Apollomics in China that also includes an ongoing Phase 1 pharmacokinetics (PK) and tolerability study.
The Phase III clinical trial is part of a randomized, double-blind, placebo controlled, bridging study program that will evaluate the efficacy of uproleselan in combination with chemotherapy, compared to chemotherapy alone, for treating relapsed/refractory AML, in Chinese patients. The trial will enroll approximately 140 adult patients with primary refractory AML or relapsed AML (first or second untreated relapse) and eligible to receive induction chemotherapy. The primary endpoint for the Apollomics Phase III trial is overall survival. Secondary outcome measures include the rate and duration of remission, and whether uproleselan could reduce the rate of oral mucositis, a chemotherapy-related side effect. Apollomics expects to conduct this study at approximately 20 blood cancer clinical research centers across China. Additional information on the Phase III trial can be found on clinicaltrials.gov (NCT05054543).
On 6 January 2020 GlycoMimetics, Inc. and Apollomics, Inc., announced an exclusive collaboration and license agreement for the development and commercialization of uproleselan and GMI-1687 in Mainland China, Hong Kong, Macau and Taiwan, also known as Greater China.
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