PCI Biotech reports successful completion of second dose group in a Phase I/II Amphinex® trial. Strong anti-tumour response observed in all patients

Oslo, 19 January 2010 - PCI Biotech reported today that it has completed the treatment of the second dose group in the phase I/II study of its proprietary photosensitiser Amphinex® used in combination with the cytotoxic agent bleomycin in cancer patients. To date seven patients have been given a single photochemical internalisation (PCI) treatment of Amphinex® with all the treated tumours in all patients disappearing within a few weeks of treatment. Furthermore, no drug-related serious adverse events have been recorded.

”We are very excited by the positive results that have been reported from University College Hospital (UCH) in London. The strong antitumour response seen in all patients treated with Amphinex® is far better than expected at the first dose levels and indicates that the positive pre-clinical results obtained with our PCI technology are transferrable to treatment in humans”, says PCI Biotech CEO Per Walday.

When activated by light, Amphinex® promotes effective local delivery of a variety of therapeutic molecules, e.g. bleomycin, through triggered endosomal release. The primary objective of the UCH study is to assess the maximum tolerated dose of Amphinex®, in PCI treatment with bleomycin. Secondary objectives include determination of the antitumor activity of the treatment, as well as the pharmacokinetics of Amphinex®. The study has also been designed to include patients with as wide as possible a range of cancers and has already included sarcoma, breast, and head and neck cancer patients. The effectiveness of the PCI treatment seems to be similar across all cancers treated so far, with all the treated tumours disappearing within a few weeks of treatment. The PCI-technology could therefore potentially be used for local treatment of several different cancers.

The patients at the third dose level of Amphinex® will now be treated as soon as possible, with preliminary results from the complete trial expected within the first half of 2010.