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Date: 2010-03-29
Phase: II
Anouncement: Launch
Biotech: Neovacs (France)
Pharma:
Product: TNF alpha-Kinoid® (TNF-K)
Disease: rheumatoid arthritis
Country: France, Belgium, Switzerland
Other: Neovacs has initiated, in France, treatment of the first patient in a Phase II clinical trial to evaluate the TNFalpha-Kinoid® (TNF-K) in rheumatoid arthritis patients who have failed treatment with an anti-TNF alpha; monoclonal antibody because of the development of resistance to monoclonal antibodies.

This trial is the initial clinical work package in the TRACKER program, for which Neovacs and Biomedical Diagnostics (bmd), an in vitro diagnostics company specializing in auto-immune disease, obtained, in 2008, a €7.9 million grant (including €6.4 million for Neovacs, as project leader) from the French state innovation agency Oséo ISI.

This randomized, double-blind, placebo-controlled Phase II study is being conducted in 3 countries: France, Belgium and Switzerland. The trial will enroll up to 48 patients. The primary objective is to select the dose levels and dosing schedule to be tested in a subsequent Phase IIb/III study. The treatment’s safety and clinical efficacy are secondary endpoints.
The trial results are expected in mid-2011 and will be followed by a Phase IIb/III trial.