Cyclacel Pharmaceuticals, Inc. (Nasdaq: CYCC) today announced that the independent Data Safety Monitoring Board (DSMB) of SEAMLESS, recommended that the Phase 3, randomized, registration-directed study of sapacitabine in elderly patients with acute myeloid leukemia (AML) should enter the randomized stage as planned.
Judy H. Chiao , M.D., Vice President, Clinical Development and Regulatory Affairs of Cyclacel, commented:
“The DSMB’s recommendation to continue our SEAMLESS Phase 3 study of sapacitabine in patients aged 70 years or older who are not candidates for or have refused intensive induction chemotherapy confirms that the treatment regimen of administering sapacitabine in alternating cycles with decitabine is safe and tolerable in the multicenter setting. The objective of the randomized stage of the study is to establish the role of sapacitabine in the front-line treatment of AML in this population with a high unmet medical need”
Read full press release here.
CYCC stock traded 2fold of its 10day average volume as of 12:30 p.m. EST with posted gains of 25%.
Cyclacel Pharmaceuticals, Inc.
200 Connell Drive
Berkeley Heights, NJ 07922
Cyclacel is a biopharmaceutical company developing oral therapies that target the various phases of cell cycle control for the treatment of cancer and other serious diseases.Sapacitabine (CYC682), an orally-available, cell cycle modulating, nucleoside analogue, is in Phase 3 development for the front-line treatment of acute myeloid leukemia in the elderly and Phase 2 studies for myelodysplastic syndromes, lung cancer and chronic lymphocytic leukemia.Seliciclib (CYC202 or R-roscovitine), an orally-available, CDK (cyclin dependent kinase) inhibitor, is in Phase 2 studies for the treatment of lung cancer and nasopharyngeal cancer and in a Phase 1 trial in combination with sapacitabine.