At Celericon we successfully established a GMP-compliant process for the manufacturing of therapeutically active exosome-containing VSF. The ample preclinical in vivo and in vitro data obtained with these therapeutic preparations support the rapid translation of these findings into clinical testing in humans.
Our experience in the design of manufacturing processes and the control of supply chains enables us to precisely define the regulatory requirements and CoGs for phase 1 and phase 2 clinical trials.
We expect the first clinical data to be available by the end of 2018.
IP for the manufacturing and application of therapeutically active exosome-containing VSF preparations has been registered for the PMU early in 2017 and in January 2018 the IP investigation phase was initiated via a formal PCT process