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 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, and patient inclusion will be in 2012 and 2013. Progression free survival at 6 months is the primary endpoint.
Patient inclusion started in May 2012, and the first patient was treated at The National Center for Tumor Diseases (NCT), University Hospital Heidelberg, Germany. Five highly respected cancer institutes in four European countries are currently involved in the study, and one additional institute (Aintree University Hospital in Liverpool, UK) is about to be included. 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. The company is also exploring the possibility to open additional sites in India. India has a very high incidence of head & neck cancer, and has a number of hospitals offering high quality treatment options for head & neck cancer patients.
The lowest dose used in the Phase I/II study has been chosen for further development. Doses below this level have been studied in an extension study to the Phase I/II trial, to further investigate the therapeutic effect in the lower dose range. The extension study is performed at University College Hospital (UCH) in London, and inclusion of patients was completed during Q2 2012.Three patients were treated in the extension study with an Amphinex dose of 0.125mg/kg and it was decided that there was no need for further reduction of the Amphinex dose. Results from the three patients supports the previously selected dose of 0.25mg/kg for the ENHANCE study.