Benzinga | Nov 23, 2021 04:32PM EST

Apollomics Inc. Doses First Patient In Phase 3 Clinical Trial In China of GlycoMimetics' Uproleselan For he Treatment oOf AML

GlycoMimetics, Inc. (NASDAQ:GLYC) announced today that Apollomics has dosed the first patient in China in a Phase 3 clinical trial of APL-106 (uproleselan injection) for the treatment of adults with relapsed or refractory acute myeloid leukemia (AML). Apollomics' Phase 3 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 3 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.

"Dosing of the first patient in this Phase 3 clinical trial in Greater China is a significant accomplishment for Apollomics and comes quickly on the heels of our recent completion of enrollment in our own pivotal Phase 3 trial evaluating uproleselan in addition to a standard chemotherapy regimen in patients with relapsed/refractory AML," commented Harout Semerjian, GlycoMimetics Chief Executive Officer.

The primary endpoint for the Apollomics Phase 3 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 3 trial can be found on clinicaltrials.gov (NCT05054543)