Cyclacel Pharmaceuticals Inc.(NASDAQ:CYCC) has traded as high as $.78 during today’s trading session and last traded at $.69 for a gain of 14.81% from Friday’s close… CYCC shares have traded as high as $1.85 over the last 52 weeks, which is 62.7% off that high at last traded stock price.
CYCC announced today new topline response data from an ongoing, multicenter, Phase 2 randomized trial of oral sapacitabine capsules, a novel nucleoside analogue, in older patients with myelodysplastic syndromes (MDS) after treatment failure of hypomethylating agents, such as azacitidine and/or decitabine. Eight patients responded with 2 complete remissions (CR), 2 complete remissions with incomplete platelet count recovery (CRp) and 4 major hematological improvements of platelet counts or neutrophils. More than 50% of the patients are still alive and longer follow-up is needed to assess 1-year survival and overall survival. Get my next ALERT 100% FREE
“MDS patients have poor outcome after treatment failures of front-line hypomethylating agents. The interim response data indicates that sapacitabine is active in this patient population,” said Hagop Kantarjian, M.D., Chairman & Professor, Department of Leukemia, The University of Texas MD Anderson Cancer Center and principal investigator for the study. “Front line treatment of MDS with hypomethylating agents results in a CR rate ranging from 5.6% to 17%. It is encouraging to observe CRs in MDS patients treated with sapacitabine as a single agent after failures of hypomethylating agents.”
“We are encouraged by these interim results with sapacitabine as a second line treatment of older patients with myelodysplastic syndromes (MDS),” said Judy H. Chiao, M.D., Cyclacel’s Vice President, Clinical Development & Regulatory Affairs. “We plan to initiate discussions with the FDA regarding potential registration pathways in MDS patients after treatment failure of hypomethylating agents. We are also looking forward to continue enrollment in ‘SEAMLESS’, our pivotal Phase 3 study of sapacitabine in elderly patients with acute myeloid leukemia (AML). Sapacitabine may emerge as the first oral drug that could address the unmet medical need in both AML and MDS patients.” (Read more)
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