Chiron Corporation and the Multiple Myeloma Research Consortium have initiated a Phase I clinical trial of CHIR-258 in multiple myeloma, a type of cancer.

CHIR-258, an orally available kinase inhibitor developed by Chiron, is the first drug candidate to undergo clinical study through the MMRC, a non-profit organization that integrates leading academic institutions with the goal of accelerating drug development in multiple myeloma. The MMRC member institutions expected to enroll patients in the trial are Dana-Farber Cancer Institute, H. Lee Moffitt Cancer Center & Research Institute and the Mayo Clinic. Emory University also is expected to enroll patients in the trial, a Chiron release said.

Stephen Dilly, chief medical officer, Chiron BioPharmaceuticals says, "The MMRC model fits well with Chiron's translational medicine approach to oncology drug development, and the multi-targeted specificity of CHIR-258 makes it a promising candidate for development in solid and haematologic malignancies, including multiple myeloma."

This Phase I trial of CHIR-258 in multiple myeloma is designed to evaluate the safety, tolerability, and pharmacokinetic and pharmacodynamic profiles of CHIR-258 in these patients. The maximum tolerated dose for CHIR-258 has not been reached in current Phase I trials, as demonstrated by preliminary data from a Phase I trial of CHIR-258 in solid tumors recently presented in an award-winning poster at the 2005 annual meeting of the American Society of Clinical Oncology.

Unlike many kinase inhibitors that only target vascular endothelial growth factor (VEGF), CHIR-258 inhibits receptors in the fibroblast growth factor (FGF) pathway, as well as VEGF and platelet-derived growth factor (PDGF). FGF receptor tyrosine kinase inhibition is potentially of therapeutic significance to a group of myeloma patients whose cancer cells express high levels of surface FGF receptors. This specific efficacy hypothesis, to be examined in this Phase I trial, was derived from prior collaborative work between Chiron and MMRC, which was published in the medical journal of the American Society of Hematology. This incorporation of preclinical data into clinical trial design is an example of Chiron's translational medicine approach to oncology drug development.

CHIR-258 is a novel, orally available tyrosine kinase inhibitor. Preclinical data show that CHIR-258 works to inhibit multiple kinases associated with different cancers, including acute myeloid leukemia (AML) and multiple myeloma.