A new milestone achieved with IFNalpha-Kinoid in the phase I/II study in Lupus patients
Neovacs has received DSMB authorization to proceed to the next dose level in its ongoing phase I//II trial in lupus. Administration of the second dose level in patients recruited in July was completed as expected. Having reviewed the data related to these patients on September 24, 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 dose of INFalpha-Kinoid. Neovacs is now recruiting patients for this dose group.
“We are making rapid progress in our phase I/II trial with our IFNα-Kinoid drug candidate to treat patients suffering from the lupus disease. The DSMB’s’ decision confirms the good tolerability of IFNalpha-Kinoid to date, which has now been administered to patients at two dose levels. We are encouraged by our good progress and our objective of recruiting up to 28 patients should be achieved quickly.” commented Pierre Vandepapelière, MD, PhD in biomedical medicine and Neovacs’ Chief Medical Officer.
Preliminary results of the study are expected during the first half of 2011. The study is placebo-controlled, double-blind with dose-escalation and randomisation 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 IFNalpha-Kinoid. Secondary objectives include analysis of the immune response and measurements of disease activity and IFNalpha markers.
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