Ascentage Pharma (6855.HK), clinical-stage biotechnology company, has dosed its first patient in a Phase Ib/II clinical study of the company's novel Bcl-2 inhibitor APG-2575, as a single agent or in combinations for the treatment of patients with relapsed/refractory chronic lymphocytic leukaemia/small lymphocytic lymphoma (r/r CLL/SLL) (APG2575CU101; EudraCT#2020-002736-73) in Ukraine, it was reported on Tuesday.
The global multicentre phase Ib/II study was aimed at evaluating the safety and efficacy of APG-2575 as a single agent or in combinations for the treatment of patients with r/r CLL/SLL. The study has recently received Clinical Trial Application approvals from the Ministry of Health of Ukraine and the Ministry of Health of the Russian Federation.
The product is a novel, orally administered Bcl-2-selective inhibitor being developed by the company. It has received clearances and approvals for multiple Phase Ib/II clinical studies in China, Australia, and the US, and is presently being developed in a range of hematologic malignancies globally. Recent studies in CLL showed that combining a BTK inhibitor with a Bcl-2 inhibitor can deepen responses and shorten treatment durations from long-term to cyclic treatments, making it possible for patients to achieve complete remission and therefore discontinue treatment.
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