Oslo, 29 May 2012 – PCI Biotech (PCIB) the Norwegian biopharmaceutical company, reported today that it has completed inclusion of patients in the phase I/II extension study of Amphinex® in combination with the cytotoxic agent bleomycin. The objective of the study was to investigate doses below the levels used in the phase I/II study that was completed in 2011.
The extension study is performed at University College Hospital (UCH) in London. Three patients were treated in the extension study with an Amphinex dose of 0.125mg/kg and it has been decided that there is no need for further reduction of the Amphinex dose. Results from the 3 patients supports the previously selected dose of 0.25mg/kg for the Phase II study of Amphinex in combination with bleomycin in the treatment of head & neck cancer patients. Inclusion of patients in the Phase II study started earlier this month.