PCI Biotech Holding ASA reported that the treatment evaluation of the fourth dose cohort in the Phase I/II study of fimaporfin (Amphinex®) in patients with inoperable bile duct cancer has been completed. The Cohort Review Committee (CRC) of clinical experts and company representatives has recommended that the study progress into Phase II, based on promising early signs of efficacy in the last cohorts. The CRC has reviewed data from twelve patients that have completed the safety evaluation window and no dose limiting toxicities or other safety concerns have been reported thus far in the study.  CRC's recommendation is based on early promising signs of tumour response in the last dose cohorts (both partial and complete responses), combined with experience from earlier clinical studies with fimaporfin.

The Phase II part of the study will be slightly modified to draw on the experiences gained from Phase I, as well as recommendations from the investigators and PCI Biotech's Scientific Advisory Committee.  Phase II will commence when the amended protocol has been approved by regulatory authorities and ethics committees.