We know that, Sapacitabine is an oral nucleoside analog prodrug that acts through a
dual mechanism. The compound interferes with DNA synthesis by causing
single-strand DNA breaks and induces arrest of the cell division cycle
at G2 phase. Both sapacitabine and its major metabolite, CNDAC, have demonstrated
potent anti-tumor activity in both blood and solid tumors in preclinical
studies. In a liver metastatic mouse model, sapacitabine was shown to
be superior to gemcitabine (Gemzar; Lilly) or 5-FU, two widely used
nucleoside analogs, in delaying the onset and growth of liver
metastasis.
Cyclacel has initiated a number of clinical trials to evaluate
sapacitabine in both solid and hematological tumors laying the
foundation for future Phase 2 studies and combination studies with other
anti-cancer agents. Three Phase 1 studies have been completed, which
evaluated safety and pharmacokinetics of a variety of dosing schedules
in approximately 120 patients with solid tumors. Sapacitabine is
currently being evaluated in two Phase 2 trials in patients with
advanced cutaneous T-cell lymphoma (CTCL) and in elderly patients with
acute myeloid leukemias (AML).
Now Cyclacel Pharmaceuticals, Inc. announced new data from an ongoing,
multicenter, Phase 2 randomized trial of oral sapacitabine capsules in
older patients with myelodysplastic syndromes (MDS) after treatment
failure of front-line hypomethylating agents, such as azacitidine or
decitabine.
