Neovacs, a biotech company focused on an active immunotherapy technology platform (Kinoids) with applications in the treatment of autoimmune diseases, inflammatory diseases and cancer has received DSMB authorization to proceed to a higher dosage in its ongoing phase 1/2 trial in lupus.
Administration of the third dose level in patients recruited since September was completed as expected. Having reviewed the data related to these patients on November 5, the Data and Safety Monitoring Board, an independent committee which is responsible for overseeing the conduct of the study and in particular for patient safety, authorized Neovacs to proceed to the next higher and final dose of INF-?-Kinoid. Neovacs is now able to finalize recruitment of patients for this phase 1/2 trial, as planned.
The DSMB’s’ decision confirms the good tolerability of IFN-?-Kinoid to date, which has now been administered to patients at three dose levels. Rapid progress has been made so far in this Phase 1/2 trial and the company is confident in achieving its objective of releasing preliminary results by the end of the first half 2011.
The study is placebo-controlled, double-blind with dose-escalation and randomization at each dose level. Patients must present symptoms of moderate disease and the primary objective of the ongoing study is to gather data on the tolerability and safety of IFN-?-Kinoid. Secondary objectives include analysis of the immune response and measurements of disease activity and IFN-? markers.
Date: November 15, 2010