On March 23, 2020 Ascentage Pharma (6855.HK), a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, reported that the global Phase Ib/II clinical study of APG-2575, a Bcl-2 selective inhibitor, as a single agent or in combination for the treatment of relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (r/r CLL/SLL), has dosed its first patient in the United States (Press release, Ascentage Pharma, MAR 23, 2020, View Source [SID1234555773]).
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This global multicenter, open-label, Phase Ib/II dose-escalation and dose-expansion study is designed to evaluate the safety, tolerability, and anticancer activity of APG-2575 as a single agent or in combination with rituximab or acalabrutinib in patients with r/r CLL/SLL.
APG-2575 is a novel, orally administered Bcl-2‒selective inhibitor being developed by Ascentage Pharma. APG-2575 is designed to treat several hematologic malignancies by selectively blocking Bcl-2 to restore the normal apoptosis process in cancer cells. Ascentage Pharma has previously commenced a Phase I study of APG-2575 as a single agent in the United States, Australia, and China. Ascentage Pharma recently received clearances in China and the United States for three Phase Ib/II clinical studies of APG-2575, continuing clinical development of APG-2575 in multiple disease conditions globally.
"APG-2575 is a key drug candidate in our development pipeline targeting apoptosis. Upon receiving clearance from the US FDA, we promptly initiated the trial and achieved dosing of its first patient," said Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma. "We look forward to effectively advancing this critical clinical development program, which hopefully will soon benefit patients with r/r CLL/SLL."