LOS ANGELES, CA -- (Marketwire) -- 02/21/13 -- Cyclacel Pharmaceuticals is a development-stage biopharmaceutical company dedicated to the development and commercialization of novel, mechanism-targeted drugs to treat human cancers and other serious diseases. Cyclacel's strategy is to build a diversified biopharmaceutical business focused in hematology and oncology based on a development pipeline of novel drug candidates. Cyclacel's clinical development priorities are focused on sapacitabine, an orally available, cell cycle modulating nucleoside analogue. The oral dose availability is one major differentiator Cyclacel offers with its sapacitabine candidate.
In 2007, Dr. Kantarjiian from the Leukemia Department at the University of Texas's Cancer Center called sapacitabine, "one of the most exciting drugs in development for AML since cytarabine, the current standard of care."
Here we discuss what is on the horizon for Cyclacel and this drug in the short and long term.
Currently, sapacitabine is being evaluated in the SEAMLESS Phase III trial being conducted under a special protocol assessment (SPA) agreement with the US Food and Drug Administration for the front-line treatment of acute myeloid leukemia (AML) in the elderly. It is also in Phase II studies for AML, myelodysplastic syndromes, non-small cell lung cancer (NSCLC) and chronic lymphocytic leukemia.
In October of last year at the Hematologic Malignancies Conference, Cyclacel announced impressive data regarding survival of elderly patients in its Phase II trial with intermediate-2 or high-risk myelodysplastic syndromes (MDS) after failure of front-line treatment. Per Wikipedia, myelodysplastic syndromes (formerly known as pre-leukemia) are:
"A diverse collection of blood related medical conditions that involve ineffective production of the myeloid class of blood cells."
In Cyclacel's October press conference, the company announced median overall survival to date for the 63 patients in the Phase II study at 252 days or approximately eight months. Median overall survival for 41 out of 63 patients with 10% or more blasts in their bone marrow is 274 days or approximately nine months. This compares to the median survival for patients as defined by the International Prognostic Scoring System (IPSS) at 4.3 to 5.6 months.
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