Oslo, 25 February 2013 - PCI Biotech (PCIB) the Norwegian biopharmaceutical company, reported today that it has decided how to optimize the treatment procedure for intra-tumour illumination in the ENHANCE study. The company has also decided to modify the inclusion/exclusion criteria to broaden the patient population and to achieve a more rapid patient inclusion.
Inclusion of patients treated with superficial illumination will continue in the ENHANCE study, while the intra-tumour illumination procedure is optimized in a parallel intra-tumour part of the study. This part of the study will be performed at selected hospitals with extensive experience with photodynamic therapy. The Netherlands Cancer Institute in Amsterdam, Netherlands will be the coordinating site.
The Amphinex dose will not be modified; the optimization will be performed solely by modifying the light dose. Total number of patients in the dose optimisation part of the study will depend on the number of dose escalations needed to find an efficient and safe light dose. Proof of Concept (PoC) of efficacy and safety for intra-tumour treatment and final confirmation of light dose for the ENHANCE study will be achieved by inclusion of 12-15 patients at the selected light dose. Patients treated at this level will be included in the ENHANCE study.
Inclusion of patients in the parallel optimisation part of the ENHANCE study is expected to start in Q2 2013, subject to approvals from relevant authorities. The PoC part of the study may be completed and reported in 2H 2013 or early 2014, depending on the number of escalations needed.
Patient inclusion in the ENHANCE study has been slower than initially expected, due both to too strict inclusion criteria and the too strong effect with intra-tumour illumination, with 8 patients treated so far. To increase the number of patients eligible for the PCI treatment in head and neck cancer, and to speed up the inclusion, it has been decided to broaden the patient population by also including metastatic patients with a need of local disease treatment. This exclusion criterion has proven to limit patient inclusion.
The intention is still to include up to 80 patients in the ENHANCE study, maintaining the possibility to file a Marketing Authorization Application (MAA) in Europe if the favourable results in the Phase I/II study at University College Hospital in London is carried forward in the ENHANCE study.