Cephalon Initiates Patient Enrollment In Rigerimod Phase IIb Clinical Trial

The study was designed to allow US based investigators and the FDA to evaluate Rigerimod (Lupuzor) as a treatment for lupus before commencing a Phase III clinical trial.

Cephalon has involved many centres in the US. The study is expected to be extended to EU sites within a few months. The data generated from the trial will be part of the package to be submitted to the FDA and other regulatory authorities for approval.

Further, Cephalon has entered into a separate sub-licence agreement with Symbio Pharmaceuticals, so as to prepare for the commercial development in Japan.

As per the terms of the agreement, Cephalon has all commercialisation rights to Rigerimod (Lupuzor) in Japan, and Symbio is granted an exclusive right to conduct a Japanese-based Phase I clinical study which is mandatory for a future filing of Rigerimod (Lupuzor) with the Japanese regulatory bodies.

Dimitri Dimitriou, CEO of ImmuPharma, said: “We are extremely encouraged with the progress Cephalon is making with regards to the US trials, first steps into Japan and importantly their commitment to the Lupuzor programme.”