PCI Biotech starts dosing in Phase I extension study for bile duct cancer


Norwegian biopharmaceutical firm has started dosing patients in a Phase I extension study with fimaCHEM to treat inoperable perihilar bile duct cancer.

Designed for enhancement of chemotherapeutics, fimaCHEM is a new approach for the localised treatment of cancer developed through the firm’s new photochemical internalisation (PCI) technology platform.

The extension study is based on a completed Phase I clinical trial that demonstrated encouraging tumour responses and overall survival data with a single fimaCHEM treatment.

Set to include at least six evaluable subjects, the Phase I extension study will assess the safety and tolerability of repeated treatments with fimaCHEM.

Intended to further optimise the treatment regimen in Phase II, the extension study will include administration of second fimaCHEM treatment at three to four months following the first treatment.

"It is exciting to explore whether these results can be further improved by repeated fimaCHEM treatments and I look forward to working with my fellow investigators on this study."

Study’s principal investigator professor Jörg Trojan said: “fimaCHEM represents a novel local treatment approach for inoperable perihilar bile duct cancer patients and a single treatment with the technology has already shown promising early signs of efficacy compared to standard treatment options.

“It is exciting to explore whether these results can be further improved by repeated fimaCHEM treatments and I look forward to working with my fellow investigators on this study.”

In preclinical studies, fimaCHEM was found to significantly enhance a chemotherapy medication called gemcitabine.

The local enhancement of gemcitabine with fimaCHEM can be performed using routine endoscopic methods.

In addition to fimaCHEM, PCI Biotech portfolio includes T-cell induction technology fimaVACC for therapeutic vaccination and fimaNAc for the delivery of nucleic acid therapeutics.