Ponente
Descripción
CIGB 552 is a second generation synthetic peptide made up of 20 amino acids. It was obtained from chemical modifications made to the antitumor peptide L-2, which was initially identified by analyzing a peptide library corresponding to region 32–51 of Limulus anti-LPS factor (LALF) [1]. Its cytotoxic effect has been demonstrated in vitro in different murine and human tumor cell lines such as H460, and in vivo in mouse models with HT-29 xenograft, syngeneic CT-26, and in dogs with spontaneous cancer [2]. For clinical trials, the quantification of its plasmatic concentration is essential. Classical techniques such as the combination of mass spectrometry with high performance liquid chromatography have failed with CIGB552, probably due to the precipitation of the peptide together with the plasma proteins. Immunoenzymatic assays are a great alternative, since previous studies confirm their potential for the quantification of peptides [3]. The objectives of the work were to design an ELISA assay and validate the method for the quantification of the peptide in human plasma, and also to obtain anti-CIGB552 monoclonal and polyclonal antibodies for its development. The design of a sandwich ELISA with polyclonal capture antibody and monoclonal antibody for the detection of the peptide was obtained. Both types of antibodies were produced with purity greater than 95%. Regarding the validation, it was shown that the method is precise, exact, specific, selective, and robust for the quantification of CIGB 552 in human plasma. These results validate the use of the immunoassay in clinical studies and thus describe the pharmacokinetic profile of the therapeutic candidate.
