Oslo, 10 December 2012 - PCI Biotech (PCIB) the Norwegian biopharmaceutical company, reported today that it will modify the study protocol for the ENHANCE study in head and neck cancer patients. Two different light application procedures are used in this study; surface and intra tumour illumination. The ENHANCE study will continue to include patients where the tumour can be treated with surface illumination, while the treatment procedure for intra tumour illumination will be optimized.
Preliminary findings from some of the patients included in the ENCHANCE study indicates that treatment with intra tumour illumination causes stronger local treatment effects than expected and desired, and stronger treatment effects than what was observed with surface illumination in the Phase I/II-study at University College Hospital in London, UK. The Independent Data Monitoring Board has therefore recommended the company to optimise the treatment regime for intra tumour illumination before further patients are treated with this procedure.
The company will now start to assess how to optimise the intra tumour procedure, and evaluate possible changes to the protocol to speed up the development of Amphinex used in combination with bleomycin.
The development of Amphinex used in combination with gemcitabine in treatment of bile duct cancer, and the development of PCI used to enhance the effect of vaccines is progressing according to plan. The new information about the effects with intra tumour illumination will be taken into consideration in the dose finding part of the clinical study in patients with bile duct cancer.