Initiated pre-clinical trials for the use of PCI in the treatment of Bladder Cancer

Oslo, 3 December 2009 - PCI Biotech has initiated pre-clinical trials for the use of Photochemical Internalisation (PCI) in the treatment of Bladder cancer. The pre-clinical trials will be concluded during the first half of 2010, and a phase I/II study (first in man) is expected to start during 2010.

Bladder cancer is a very interesting disease area for the use of the PCI technology. Bladder cancer is the 5th most expensive cancer indication, with the highest average per-patient lift-time cost, mainly due to a high recurrence rate. The currently used pharmaceutical treatments have limited effect on recurrence and progression, and there is a large unmet medical need. The bladder is easily accessible for the three components of the PCI technology; the proprietary photosensitizer Amphinex®, light and a cytotoxic agent. When activated by light, Amphinex® promotes effective delivery of large therapeutic molecules through triggered endosomal release and can thereby enhance the efficacy of drugs. Screening studies in cell cultures indicate that several of the chemotherapeutic drugs currently used in the treatment of bladder cancer may be enhanced by PCI. Several different chemotherapeutic drugs will be tested in the pre-clinical trials, of which most are already approved for bladder cancer,.

The trials will be performed at The Norwegian University of Science and Technology (NTNU) in Trondheim, Norway and at Radboud University Nijmegen, Holland. The research at Radboud University is performed at one of the leading urology clinics in Europe under the supervision of Professor Fred Witjes, and PCI Biotech is very pleased that they have shown interest in the PCI technology. The pre-clinical trials are expected to be concluded during the first half of 2010 and PCI Biotech aims to start a phase I/II study during 2010.

The company is currently performing a Phase I/II trial at University College Hospital (UCH) in London. Amphinex® is in this study combined with the cytotoxic agent bleomycin. The study is primarily enrolling patients with Head & Neck cancer, a disease with local control issues that the PCI technology could potentially contribute to solve. The primary objective of this study is to assess the maximum tolerated dose of Amphinex®, in PCI treatment with bleomycin. Secondary objectives include determination of the antitumour activity of Amphinex® when used in combination with bleomycin, as well as its pharmacokinetics. The first dose group in the Phase I/II study has been completed, and no serious adverse events have been recorded so far. Tumour response was seen even at the first low dose. The first patients at the next dose level have been treated with Amphinex® and the results from this dose level and additional results from patients in the first dose level is expected within the end of the year

 About PCI Biotech

PCI Biotech is a Norwegian biopharmaceutical company developing a novel light directed drug delivery system based on its patented photochemical internalisation (PCI) technology. Originating from world leading research at the Norwegian Radium Hospital, the PCI method involves first injecting target cells with a photosensitiser. Therapeutic molecules are then delivered to the cells and when these are illuminated the cells’ endosomes are ruptured to allow successful uptake.PCI can enhance the delivery of all molecules taken into the cell by endocytosis. This includes most types of macromolecules, drugs carried by antibodies or nanoparticles, as well as some small molecule drugs. In addition, PCI enables the use of more toxic compounds by restricting their effects to the target site.PCI Biotech follows a dual strategy of using its technology to improve the effect both of existing drugs and for emerging treatments such as gene therapy. PCI Biotech’s first clinical study couples the proven photosensitiser Amphinex® with the cytotoxic agent bleomycin. Other studies are planned for the delivery of other cancer drugs in relevant indications.

For more information visit: www.pcibiotech.com

Contact information:
PCI Biotech Holding ASA, Hoffsveien 48, N-0377 Oslo v/Per Walday, CEO, pw@pcibiotech.no, Mobile: +47 917 93 429
Bernt-Olav Røttingsnes, CFO, bor@pcibiotech.no, Mobile: +47 913 47 021