PCI Biotech Commences Phase I/II Trials of Amphinex(R)

August 24, 2009

OSLO, August 24 /PRNewswire/ — 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.”


Source: newswire

comments powered by Disqus