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

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