Isotechnika partner nears end of patient recruitment

October 20, 2011 by Leonard Zehr

Isotechnika Pharma (TSX:ISA) said its partner, Lux Biosciences, expects to complete patient recruitment of its continuing Phase 3 trial of Luveniq (voclosporin) in North America for the treatment of non-infectious uveitis in early 2012.

Lux also has decided to modify its European regulatory strategy by withdrawing its application for marketing authorization of Luveniq for the time being, but to resubmit the application supplemented with data from the continuing Phase 3 trial. Lux previously had planned to appeal the European Medicines Agency’s decision not to approve Luveniq for non-infectious uveitis.

The continuing trial will support a resubmission to the EMA, as well as address the FDA’s request for additional clinical information, Isotechnika said, adding that Lux remains fully committed to the potential of Luveniq.