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Cyclacel's lead product candidate flunks late-stage leukemia study; shares down 19% premarket

  • Thinly traded nano cap Cyclacel Pharmaceuticals (NASDAQ:CYCC) slumps 19% premarket on light volume (although investors should expect a much larger down move) in response to its announcement that lead product candidate sapacitabine failed to achieve the primary endpoint in a Phase 3 clinical trial, SEAMLESS, in elderly patients with newly diagnosed acute myeloid leukemia (AML).
  • Participants receiving sapacitabine did not experience a statistically valid increase in overall survival compared to active control although an improvement in complete remission rate was observed. The company plans to stratify the subjects into subgroups (mine the data) to identify the patients who are most likely to benefit from treatment with sapacitabine.
  • For the past few years Cyclacel has been progressing clinical investigation of two programs in parallel with SEAMLESS. The DNA damage response program is evaluating an orally-administered, sequential regimen of sapacitabine and seliciclib, a CDK2/9 inhibitor, in patients with BRCA-positive, advanced solid tumors. The transcriptional regulation program is evaluating CYC065, a CDK2/9 inhibitor, in patients with advanced cancers with emphasis on downregulation of the Mcl-1 biomarker. This may explain why the company took over a year to report the results from SEAMLESS.
  • Sapacitabine is an oral nucleoside analogue prodrug whose metabolite, CNDAC, arrests the cell cycle by breaking up DNA.
  • Management will host a conference call this morning at 9:00 am ET to discuss the results.

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