Acute myeloid leukemia therapy.
Apollomics has dosed the first participant in a Phase III clinical trial of its new drug, APL-106 (uproleselan injection), in China to treat relapsed or refractory acute myeloid leukemia (AML) patients.
Uproleselan has been licensed by Apollomics in the Greater China region from GlycoMimetics, which discovered and developed the drug.
The drug can potentially hinder E-selectin from adhering to blood cancer cells, to destroy the leukemic cell resistance mechanism within the bone marrow microenvironment.
The randomised, placebo-controlled, double-blind, bridging trial will assess uproleselan efficacy along with chemotherapy versus chemotherapy alone to treat adult patients with relapsed/refractory AML.
Nealy 140 adults with primary refractory or relapsed AML, who are eligible for induction chemotherapy, will be enrolled in the trial.
Overall survival is the primary goal of the trial while remission rate and duration; and uproleselan’s ability to reduce oral mucositis rate will be included as secondary goals.
The company plans to carry out the trial at nearly 20 blood cancer clinical research centres in the country.
This trial is part of Apollomics complete development program in China, which also comprises a Phase I pharmacokinetic and tolerability trial currently underway.
Apollomics co-founder, chairman and CEO Guo-Liang Yu said: “As our first Phase III clinical trial, dosing of the first patient with APL-106 is a major inflection point for Apollomics as we now become a company in late-stage development.
APL-106 acts via an innovative mechanism that drives cancer cells out of the bone marrow, making them a prime target to be killed by chemotherapy.
“This combined treatment approach could have a meaningful impact on the lives of patients living with relapsed or refractory AML.”
AML is a kind of cancer that affects the blood and bone marrow.