Keryx commences phase II trial in leukemia

This clinical trial will assess the objective response rate and evaluate the pharmacokinetics and safety and tolerability of KRX-0401 (perifosine) as a single agent in relapsed or refractory acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), chronic lymphocytic leukemia (CLL), high-risk myelodysplastic syndrome (MDS) and chronic myeloid leukemia in the blastic phase.

KRX-0401 is a novel, first-in-class, oral anticancer agent that modulates AKT and a number of other key signal transduction pathways, including the MAPK and JNK pathways. The compound has shown single agent partial responses or long-term disease stabilizations in solid tumors, including sarcoma and prostate cancer.

“There is an increasing focus on inhibition of the AKT pathway as a potentially rewarding anti-leukemia approach. The clinical and preclinical data gathered on this study will help to assess AKT as a potential target, and will tell us if perifosine is useful for these patients, who desperately need an improvement over current therapies,” Dr Frank Giles the principal investigator for the study, and a professor at the department of leukemia at the MD Anderson Cancer Center in Houston.