Phase I/II trial of Amphinex uses photochemical internalisation approach

PCI Biotech Holding ASA, the Norwegian drug delivery company focusing on effective delivery of cancer therapeutics, today announced that the first patient has received treatment in the Phase I/II trial with the lead candidate Amphinex(R), which uses a new approach called photochemical internalisation. The patient was treated at the University College Hospital (UCH) in London. PCI's proprietary photosensitiser Amphinex(R) is in this study combined with the therapeutic agent bleomycin. When activated by light, Amphinex(R) promotes effective delivery of large therapeutic molecules such as bleomycin through triggered endosomal release. The trial will investigate a broadly representative spectrum of cancers including head and neck cancer and breast cancer, to demonstrate the safety and potential of this new approach.

The primary objective of this study is to assess the maximum tolerated dose of Amphinex(R), in PCI treatment with bleomycin. Secondary objectives include determination of the antitumor activity of Amphinex(R) when used in combination with bleomycin, as well as its pharmacokinetics.

Colin Hopper, Principal Investigator at UCH, said: "At UCH we are dedicated to high quality patient care and we have extensive experience in the use of photodynamic therapy to treat cancer patients. PCI is a very exciting new approach in photodynamic medicine that has shown great promise in preclinical studies. We are very proud of being the first centre to move this new technology into the clinic."

Per Walday CEO of PCI Biotech, said: "This first in man trial is an important step forward for the company. We are confident that our approach addresses one major challenge in oncology - how to deliver therapeutics with large enough loads to effectively destroy tumours while at the same time reducing the risk of damaging healthy cells. Bleomycin is ideal for demonstrating this - there is no doubt about its therapeutic potential, but until now delivery problems and associated toxicity have prevented the realisation of its full potential. We expect to have the first preliminary results of the trial early in 2010."

In addition, whilst our main initial focus is cancer, we strongly believe the PCI technology also has potential to improve the effect of emerging treatments such as gene therapy and therapies based on nanotechnology or on biotechnological principles. In particular, we are looking at siRNA through projects funded by EU and by the Norwegian Research Council."