CYC065 Successfully Treat an Advanced Solid Tumor Patient in Phase 1 Trial

Release Date: 27-Sep-2019

A biopharmaceutical company named Cyclacel Pharmaceuticals, recently announced treatment of the first patient with an oral formulation of CYC065. This drug is a CDK2/9 inhibitor, which is able to disturb the cell cycle of the cancerous cells. This result is observed in the part 3rd of a Phase 1 clinical study (CYC065-01). This study involves the evaluation of an agent CYC065 and conducted on the patents with advanced solid cancers. Parts 1 and 2 of the study are evaluating CYC065 administered as an intravenous infusion.


CYC065 is a second generation CDK2/9 inhibitor, which is under Phase 1 clinical studies as a single agent for the management of patients with advanced solid tumor. The trial is also ongoing for the management of relapsed Chronic Lymphocytic Leukemia (CLL), in combination with venetoclax and in relapsed or refractory AML. Similarly to FDA approved CDK4/6 inhibitors, CYC065 may be most useful in combination with other anticancer drugs, including B- cell Lymphoma 2 (BCL2) inhibitors, such as venetoclax, or HER2 inhibitors, such as trastuzumab


The 3rd phase of clinical trial Study i.e. CYC065-01, is anticipated to involve up to approximately 70 patients with advanced cancers. The main objective of this trial is to determine the safety profile, pharmacokinetics and pharmacodynamics study and identifying the recommended and suitable Phase 2 dose of both intravenously and orally administered CYC065.


According to the Spiro Rombotis, President and Chief Executive Officer of Cyclacel, we are excited to report that the first patient has been treated with oral CYC065 in part 3 of our Phase 1 study. We recently reported that in part 2 of the same study, a patient with endometrial cancer with MCL1 amplification achieved tumor shrinkage after single agent CYC065 administered by intravenous infusion. The study is being conducted at the Dana-Farber Cancer Institute. We look forward to reporting data from Part 2 and 3 of this study in 2020.

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