Successful completion of the second group in the intra-tumour light dose escalation part of the ENHANCE study
Lysaker, 22 August 2014 - PCI Biotech (PCIB) the Norwegian biopharmaceutical company, reported today that the treatment evaluation of the second group in the intra-tumour light dose escalation part of the ENHANCE study has been completed. ENHANCE is a phase II study of Amphinex® in combination with the cytotoxic agent bleomycin in recurrent head and neck cancer patients. No serious safety concerns were raised and strong clinical effects with clear indications of tumour response were seen at this light dose level.
A Dose Review Committee (DRC) of clinical experts and company representatives has been established to evaluate the results and provide recommendation for the continuation of the study. The DRC has recommended that three further patients are included at the same light dose level, before final selection of the light dose for proof of concept with intra-tumour treatment. Patients for the next group are currently being screened and will be treated with Amphinex® as soon as possible.