This is the second of several phase I studies to be conducted in order to evaluate the safety and initial efficacy of the candidate R763 in different types of cancers, including solid tumors, hematological malignancies, and in combination with standard therapies.
Merck Serono licensed development and commercialization rights to R763 and Rigel's Aurora kinase program in October 2005.
This phase I study is designed to evaluate safety and tolerability at two different dosing regimens of the Aurora kinase inhibitor. Subjects with acute or chronic myeloid leukemia (AML or CML) or myelodysplastic syndrome (MDS) will be enrolled in each regimen and dosed orally with R763.
“R763 has shown encouraging results in in vitro and in vivo models of hematological malignancies where Aurora kinase is thought to play a role,” said Donald Payan, executive vice president of Rigel.