Growing cancer cells (purple) surrounded by healthy cells (pink), a primary tumour spreading to other body parts through the circulatory system. Credit: Darryl Leja, National Human Genome Research Institute, NIH.

Ascentage Pharma has started dosing patients in a Phase I clinical trial of its Bcl-2 selective inhibitor APG-2575 to treat hematologic malignancies in China.

Formulated for oral administration, APG-2575 has been designed to specifically block Bcl-2 to restore the normal apoptosis process in cancer cells.

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The Phase I trial is intended to evaluate the safety and tolerance of the compound in patients suffering from hematologic malignancies. The trial will also aim to determine the maximal tolerated dose (MTD) or recommended Phase II dose (RP2D).

It will enrol subjects with acute myelogenous leukemia (AML) or non-Hodgkin’s lymphoma (NHL).

The first participant was dosed at the Institute of Hematology, Blood Disease Hospital of Chinese Academy of Medical Sciences during the initial dose-escalation part.

Ascentage Pharma chairman and CEO Dr Dajun Yang said: “APG-2575 is a key product in our development pipeline of apoptosis. Initiating the clinical trial in China represents a new step in our global clinical development. We believe that APG-2575 may provide more therapy options to patients with blood diseases.”

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APG-2575 is also being evaluated as a monotherapy in an ongoing multi-centre Phase I dose-escalation trial across multiple sites in the US and Australia.

This trial has been designed for people with various types of blood cancer, including AML, NHL, chronic lymphocytic leukaemia (CLL) and multiple myeloma (MM).

Currently, the study has completed four dose cohorts in the US and Australia.

Preliminary trial data showed that APG-2575 was well tolerated with a favourable safety profile. The therapeutic also showed promising anti-tumour activity in relapsed / refractory CLL.