Successful completion of the first dose group in the Phase I/II study of Amphinex® in cancer patients

Posted on Oct 19, 2009

Oslo, 19 October 2009 – PCI Biotech has completed the treatment of the first dose group in the phase I/II study of Amphinex® in cancer patients. No serious adverse events have been recorded and tumour response was seen even at this low dose. The study is primarily enrolling Head & Neck cancer patients and is performed at University College Hospital (UCH) in London.

This is a dose escalating study where the patients are treated with Amphinex® in combination with the cytotoxic agent bleomycin. When activated by light, Amphinex® promotes effective delivery of large therapeutic molecules such as bleomycin through triggered endosomal release. The first dose level of the trial is now completed. The patients at the next dose level have already started to sign up for participation in the study and will be treated with Amphinex® as soon as possible.

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 antitumor activity of Amphinex® when used in combination with bleomycin, as well as its pharmacokinetics. Preliminary results from the trial are expected early in 2010.

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, Norway
Per Walday, CEO, pw@pcibiotech.no, Mobile: +47 917 93 429
Bernt-Olav Røttingsnes, CFO, bor@pcibiotech.no, Mobile: +47 913 47 021