Cyclacel Pharmaceuticals (CYCC) produced sapacitabine, an oral-drug currently in Phase III which shows encouraging life-extension results for acute myeloid leukemia (AML) and meylodysplastic syndrome (MDS) patients who are aged 70 or older, with Phase II results which already suggest patients may increase their life expectancy from three to 12 months, says Spiro Rombotis, President & CEO of Cyclacel Pharmaceuticals.
“Sapacitabine is currently in a Phase III trial called ‘SEAMLESS’ in elderly patients with AML under a SPA, or special protocol assessment, agreement we reached with the U.S. FDA. A SPA essentially guarantees that if SEAMLESS meets the criteria for success of the trial specified by the FDA, then the data would be eligible for submission in a marketing authorization,” Rombotis said.
Rombotis places special emphasis on the oral delivery of CYCC‘s drug sapacitabine, a feature unique among drugs of its kind. He says drugs for the same conditions are administered intravenously, significantly increasing the ease at which elderly patients can consume the drug without the need of medical staff, and simplifying the logistics that can result in a better life quality.
“The complexity of having a family member drive them to the doctor’s office or the hospital to receive an hour-long intravenous infusion disappears,” Rombotis said of Cyclacel‘s product. “Taking time off from work for several hours to drive grandpa or grandma to their infusion appointment for five days during a treatment week is obviously a major inconvenience, which may even preclude older patients from receiving intravenous chemotherapy.”
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