PCI Biotech AS ( PCIB.OL) (OSE:PCIB) reported today that it has
completed the successful 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 using bleomycin as the test molecule. 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.