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Cyclacel Pharmaceuticals Announces First Patient Treated With Oral CYC065 in a Phase 1 Study in Patients With Advanced Solid Tumors
“We are excited to report that the first patient has been treated with oral CYC065 in part 3 of our Phase 1 study,” said
Study CYC065-01 (NCT02552953) is intended to enroll up to approximately 70 patients with advanced cancers with the objective of determining safety, pharmacokinetics, pharmacodynamics and identifying the recommended Phase 2 dose (RP2D) of both intravenously and orally administered CYC065.
Data from 26 patients enrolled in part 1 were reported at the 2018 AACR Annual Meeting and RP2D was established for a 4-hour intravenous infusion of CYC065 once every 3 weeks. Consistent suppression of MCL1 over 24 hours after a single dose of CYC065 at RP2D has been observed in the majority of patients. Part 2 is testing a more frequent dosing schedule of one-hour infusions on Day 1, 2, 8 and 9 of a three week cycle. Part 3 is evaluating the oral formulation administered by the same dosing schedule as part 2.
CYC065, a second generation CDK2/9 inhibitor, is being evaluated in Phase 1 studies as a single agent in patients with advanced solid tumors and in combination with venetoclax in relapsed or refractory CLL, and in relapsed or refractory AML or MDS. It is mechanistically similar but has higher dose potency, in vitro and in vivo, and improved properties compared to seliciclib, a first generation CDK inhibitor. Similarly to
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