Phase I/II clinical study of Neovac's IFNα-Kinoid for lupus fully enrolled
Initial results expected in April 2011
Neovacs announced that its IFN-K-001 clinical study has recruited all 28 patients called for by the study protocol and consistent with the Company’s development plan. Initial results will be the subject of a poster presentation at the 8th European Lupus Meeting on April 8th in Porto.
The IFN-K-001 study of Neovacs’ IFNα-Kinoid is a double-blind, placebo-controlled trial. It was initiated in April 2010, with patients recruited in Belgium, Bulgaria, France and Switzerland. Investigator and patient participation in the study underscores the significant unmet medical need in this disease, and hence the potential for an innovative therapeutic approach. No new therapy has been approved for lupus for over 50 years.
The study protocol called for a progressive dose escalation through four dose levels, with each group randomized between the IFNα-Kinoid and placebo. The principal outcomes to be evaluated from the study are the safety and tolerability of the Kinoid therapy, the immune response to the Kinoid, the evolution of disease activity measures and gene signature and chemokine biomarkers. An independent safety monitoring board reviewed data relating to each dose cohort before approving the administration of the next dose level to a new cohort.
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