CX-4945: CK2 Inhibitor

Phase I Dose-Escalating Single Agent Study in Patients with Solid Tumors: CX-4945 is under investigation in a Phase I clinical trial in patients with advanced solid tumors or Castleman's disease. CX-4945 is administered orally using two separate dosing schedules and two separate formulations, and the primary endpoints of the oral dose escalating trial are determination of safety, tolerance and PK properties of CX-4945 and to select the appropriate dose for Phase II trials. Findings to date demonstrate linear pharmacokinetics using both dosing schedules, and the agent has proved to be safe and well tolerated. Exposure levels have been safely achieved that promote suppression of biomarkers for the CK2 enzyme and for key oncogenic signaling pathways. The trial centers are:

Front Range Cancer Specialists, Fort Collins, CO

MD Anderson Cancer Center, Houston, TX

The Mayo Clinic, Scottsdale, AZ

Phase I/II Study in Multiple Myeloma: The multi-center clinical study with CX-4945 is being conducted in patients with relapsed or refractory multiple myeloma. The objectives of the study are to determine the safety, tolerance and pharmacokinetic (PK) properties of CX-4945 in multiple myeloma patients and to select the appropriate dose for subsequent Phase II trials. Disease status measurements are followed throughout the trial , including chromosomal characterization of bone marrow, blood chemistry, paraprotein analysis and hematology characterization. In addition, correlative studies are performed with primary cultures ex vivo to characterize the sensitivity and response of certain phospho-proteins of a patients MM cells to CX-4945 alone, or in combination with other approved drugs. The trial centers are:

The Oregon Health & Science University Knight Cancer Institute

The US Oncology Research nationwide network