PCI Biotech is to modify the study protocol for ENHANCE, a study of its photosensitising agent, Amphinex, in combination with bleomycin and superficial and interstitial laser light, for the treatment head and neck squamous cell carcinoma unsuitable for surgery and radiotherapy and without distant metastases. Two different light application procedures are used in this study: surface and intra-tumour illumination. ENHANCE will continue to include patients where the tumour can be treated with surface illumination, while the treatment procedure for intra-tumour illumination will be optimised.
ENHANCE is a single arm, multicentre, Phase II study that will include approximately 80 patients. Progression-free survival at six months is the primary endpoint. Patient inclusion started in May, and to speed up patient inclusion further, a process is ongoing with a number of additional European university hospitals, and it is expected that some of these will participate in the study. PCI is also exploring the possibility to open additional sites in India.
Preliminary findings from some of the patients included in the study indicated that treatment with intra-tumour illumination caused stronger local treatment effects than expected and desired, and stronger treatment effects than what was observed with surface illumination in a previous 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 the treatment of bile duct cancer is reportedly progressing according to plan. According to PCI, 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.