Policy & Regulation
Ascentage Pharma doses first Chinese patient in Phase I clinical trial of APG-2575
15 July 2019 -

Biotechnology company Ascentage Pharma said on Friday that it has treated its first patient in China under its first stage Phase I clinical trial of APG-2575 for hematologic malignancies at the Institute of Hematology, Blood Disease Hospital of Chinese Academy of Medical Sciences

This Phase I trial is designed to assess the safety and tolerance of the company's APG-2575 in patients with hematologic malignancies and confirm the maximal tolerated dose (MTD) or recommended Phase II dose (RP2D). Included in this trial are patients with acute myelogenous leukemia (AML), non-Hodgkin's lymphoma (NHL).

According to the company, APG-2575 is a novel, orally administered Bcl-2 selective inhibitor. It is designed to treat hematologic malignancies by selective blocking Bcl-2 to restore the normal apoptosis process in cancer cells. Bcl-2 is the founding member of the Bcl-2 family proteins which are most notable for their critical roles in the regulation of apoptosis through the formation of heterodimers with pro-apoptotic proteins (BIM, BAD and most others).

In the US and Australia, the company has an ongoing multi-centre Phase I dose-escalation study of APG-2575 as a single agent at several academic institutions including MD Anderson Cancer Center and Mayo Clinic. APG-2575 could potentially be the first China-made Bcl-2 inhibitor. Included in this trial are patients with various types of CLL, NHL, MM, AML blood cancers. APG-2575 was well tolerated and safe and had promising anti-tumor activity in the treatment of relapsed/refractory CLL.

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