Amphinex® in combination with bleomycin, Head & Neck cancer
PCI Biotech’s lead candidate is the photosensitiser Amphinex used in combination with the generic cytotoxic agent bleomycin. A Phase I/II study of Amphinex in combination with bleomycin in cancer patients has been completed at University College Hospital (UCH) in London. A total of 19 patients were treated in this study, the majority with head & neck cancer, and strong response to treatment was seen in all patients. Amphinex seems to be well tolerated.
Phase II study in head & neck cancer patients – the ENHANCE study
The ENHANCE study is a single arm, multi-centre, phase II study to evaluate the safety and efficacy of Amphinex in combination with the generic cytotoxic agent bleomycin with superficial and interstitial laser light application in patients with recurrent head and neck squamous cell carcinoma unsuitable for surgery and radiotherapy and without distant metastases. The study will include approximately 80 patients. Progression free survival at 6 months is the primary endpoint.