The clinical trial application for a Phase 1 study with AmphinexTM, PCI Biotech’s patented photosensitiser for use with its unique light-directed PCI drug delivery technology, has been approved by the Norwegian Medicines Agency. The primary objective of this study at the Radium Hospital in Oslo is to investigate the safety and tolerability of AmphinexTM in man. In the study AmphinexTM will be used in combination with the cytotoxic agent Bleomycin. The first patient is expected to be enrolled in September.
Per Walday, CEO, said: “This is an important milestone in the development of Amphinex. Our preclinical results with Amphinex are very encouraging and we are pleased to have been given the go-ahead by the Medicines Agency to start the clinical development of our lead product.”