Cyclacel Pharmaceuticals Inc (NASDAQ: CYCC) is adding two dose levels in a protocol amendment to test higher doses of oral fadraciclib before determining the recommended Phase 2 dose anticipated in 2H of 2022, citing the absence of dose-limiting toxicities.
Fifteen patients with advanced solid tumors and lymphomas were treated with oral fadraciclib at all five doses.
In the first oral treatment cycle with fadraciclib, a cutaneous T cell lymphoma patient achieved partial response (PR).
A patient with a peripheral T cell lymphoma achieved a 38% reduction in target lesions.
An endometrial cancer patient achieved stable disease with a 15% reduction of target lesions after the first oral treatment cycle. In an earlier study of intravenous fadraciclib as monotherapy, a patient with MCL1 amplified endometrial cancer achieved confirmed complete response (CR) and remains on study after 2.5 years of treatment.
A pancreatic cancer patient achieved stable disease by the confirmatory scan for five oral treatment cycles.
For CYC140, no dose-limiting toxicities were observed to date in the Phase 1/2 study of oral CYC140.
An ovarian cancer patient in 140-101 achieved stable disease with tumor shrinkage after the first cycle.
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