Cyclacel reports Phase I data for CDK2/9 inhibitor in solid tumors

Cyclacel Pharmaceuticals Inc. (NASDAQ:CYCC) reported data from 24 heavily treated patients with advanced solid tumors in the dose-escalation part 1 of a Phase I trial showing that 8-288 mg/m²/day doses of CYC065 given once every 3 weeks were generally well tolerated with reversible neutropenia, febrile neutropenia and diarrhea reported as dose-limiting toxicities (DLTs). The recommended Phase II dose is 192 mg/m²/day CYC065. The open-label, U.S. trial also evaluated pharmacokinetics.

Part 2 of the trial is enrolling patients with cyclin E (CCNE)-amplified tumors, including subsets of high-grade serous ovarian and uterine cancers. Patients in part 2 will receive CYC065 for 2 days per week for 2 weeks of a 3-week cycle...