Neovacs published the initial results of a phase I/II study with IFN?-Kinoid in lupus patients highlight the safety, the immunogenicity and the pharmacodynamics of the therapy, according to a report by Neovacs.
The IFN-K-001 Phase I/II study was a double-blind, placebo-controlled, dose-escalation design testing four different IFN?-Kinoid dose levels. Participants have mild to moderate lupus. The main endpoints of the trial are the safety and tolerance of the IFN?-Kinoid, its capacity to induce an antibody response to IFN?, the evolution of clinical disease scores and biomarkers for disease activity, including the interferon signature, which measures changes in the activity of genes that are overexpressed in lupus.
The reported results relate to the first three dose groups (30, 60 or 120 mcg), comprising in total 20 patients. Results for the highest dose group of 8 patients at 240 mcg (including 2 placebo patients) are currently collected and analyzed.
Across all the patients recruited in the first three dose cohorts, there has been no significant adverse event associated with the Kinoid, no unusual infection, and no patient has dropped out.
Antibodies to IFN? have been induced in 80% (12 of 15) patients treated with the Kinoid. This score highlights the induction of an immune response with the IFN?-Kinoid. As expected, no immune response to IFN? was detected in the five placebo patients.
Of these 18 patients in this interim analysis, 11 had a positive interferon alpha signature on study entry: eight were treated with the Kinoid and three received the placebo. The Kinoid-treated group experienced a sharp reduction in interferon signature, demonstrating a significant down-regulation of genes associated with IFN?. The pharmaco-genomic activity of the IFN?-Kinoid is very encouraging because it shows that the antibodies to IFN? induced by Kinoid administration have a strong biological activity. The interferon gene signature will be included as one of the endpoints to be studied in later stages of development of the product.
Release Date: April 8, 2011
Filed Under: Drug Discovery