Neovacs published data from a phase 1/2 study with IFN?-Kinoid in Lupus patients who received 240 mcg of IFN-K, the highest dose of IFN-K tested.
The IFN-K-001 Phase 1/2 study is a double-blind, placebo-controlled, dose-escalation design testing four different IFN?-Kinoid dose levels. All patients recruited 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 and biomarkers for disease activity, including the interferon signature which measures changes in the activity of genes that are overexpressed in Lupus. Results for the highest dose group of 8 patients at 240 mcg (including 2 placebo patients) are presented and confirm data previously presented with the first three dose groups (30, 60 or 120 mcg of the Kinoid), comprising 20 patients
Results confirm IFN-K is well tolerated and generated a down regulation of overexpressed genes associated with interferon ? and lupus. IFN-K, at the dose of 240 mcg, induced the production of antibodies to interferon ? in all patients. In some patients, the antibodies could be measured as early as day 28, i.e. after the first 2 injections.
IFN-K induced the production of anti-interferon ? antibodies in all patients (instead of 80% of patients as previously observed) in all doses.
Release Date: July 26, 2011
Filed Under: Drug Discovery