- Cyclacel Pharmaceuticals (CYCC -7.3%) slumps on almost double normal volume on the heels of the release of final results from a Phase 3 clinical trial, SEAMLESS, assessing lead candidate sapacitabine in elderly patients with newly diagnosed acute myeloid leukemia (AML). The data were presented at ASH in Atlanta.
- Investors are apparently disappointed that there was not more of an opportunity with a subset of patients in the failed study, first announced in February.
- SEAMLESS did not achieve the primary endpoint of a statistically significant improvement overall survival (OS) in the sapacitabine + decitabine arm compared to decitabine alone, although the rate of complete remission favored the sapacitabine group, 17% versus 11%.
- In a subgroup of AML patients with white blood cell (WBC) counts less than 10K, median OS favored sapacitabine, 8.0 months versus 5.8 months. In patients with WBC counts at least 10K, OS was statistically significantly better in the decitabine arm (5.5 months versus 3.8 months; p=0.007).
- Sapacitabine is an oral nucleoside analogue prodrug whose metabolite, CNDAC, arrests the cell cycle by breaking up DNA.
- Previously: Cyclacel's lead product candidate flunks late-stage leukemia study; shares down 19% premarket (Feb. 23)
- Now read: Gilead: Avoid 2017's Frustrations
Original article