Implementation of a competitive ELISA for pharmacokinetics studies of CIGB-300 in human plasma

Abstract

CIGB-300 is a synthetic peptide that inhibits the phosphorylation mediated by enzyme casein kinase 2 (CK2) and has a marked antineoplastic effect in different preclinical models. In the clinical setting, it's explored in phase I and II studies using different routes of administration. In particular, the use of the intravenous route requires a reliable analytical method for the detection of CIGB-300 in plasma. A competitive ELISA was developed to detect and quantify the CIGB-300 peptide in human plasma samples. This system showed a detection limit of 0.030 µg/mL and a working range from 10 to 0.039 µg/mL, including concentrations achieved in plasma of patients treated with CIGB-300. In addition, the intra and inter-assay precisions were (coefficient of variation < 5 %) and (CV < 17 %) and the recovered range from 98.9 to 119.8 %. Finally, the impact of three freeze-thaw cycles and the sample storage at - 80 °C on the stability of the analyte was evaluated. We obtained a CV < 20 % for all samples in the stability study. The results support the application of this analytical method as a new tool for the pharmacokinetic studies of the early stages of clinical research with the new anticancer drug CIGB-300.

Keywords

• CIGB-300
• ELISA
• system validation
• pharmacokinetics
• intravenous route
• anticancer drug