M. D. Anderson reports first drug activity in T315I-Positive CML, ALL and JAK-2-Positive MPD

ORLANDO -- Researchers at The University of Texas M. D. Anderson Cancer Center reported today that MK-0457 (VX-680), a novel multi-kinase inhibitor, is clinically active against multiple target mutations in two types of leukemia and myeloproliferative disorders, and produces few side effects for patients.

Francis J. Giles, M.D., professor in the Department of Leukemia at M. D. Anderson Cancer Center, presented the Phase I / II trial data today at the annual meeting of the American Society of Hematology.

According to Giles, the study of 44 patients, conducted at M. D. Anderson Cancer Center and Duke University Medical Center, showed the first clinical activity of a kinase inhibitor against the T315I BCR-ABL mutation found in chronic myeloid leukemia (CML) and acute lymphocytic leukemia (ALL). In addition, the trial showed the first activity against the JAK-2 mutation found in myeloproliferative disorders (MPD), a group of blood diseases that can evolve into leukemia. MK-0457 has also been found in previous studies to inhibit Aurora kinases A, B, C and FLT3 in leukemias.

Giles reported that patients on the study experienced minimal side effects, such that no maximum tolerated dose was defined. Mild side effects included lowering of white blood cells, hair loss, nausea and inflammation of the mouth.

"MK-0457 is a drug that produces clinical and biologic activity where we have not seen it before - in T315I-positive CML and ALL and JAK-2-positive MPD. This is a very active biologic agent for patients with advanced leukemia, and has very few side effects, all of which are quite manageable," Giles said. "With the data from this trial, we have a strong rationale to take this agent forward to more definitive and larger studies."

Though CML, ALL and MPD are relatively rare cancers, they are very aggressive and often fatal after failing standard therapy, said Giles. For the subset of leukemia patients who have the T315I

Contact: Laura Sussman
University of Texas M. D. Anderson Cancer Center

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