PCI Biotech reports successful completion of second dose group in a Phase I/II Amphinex® trial. Strong anti-tumour response observed in all patients
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PCI Biotech reports successful completion of second dose group ina Phase I/II
Amphinex® trial. Strong anti-tumour response observed in all patients
Oslo, 19 January 2010 - PCI Biotech reported today that it has completed the
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 veryexcited 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 with bleomycin. 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.
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, Strandveien 55, N-1366 Lysaker
Per Walday, CEO, pw@pcibiotech.no, Mobile: +47 917 93 429
Bernt-Olav Røttingsnes, CFO, bor@pcibiotech.no, Mobile: +47 913 47 021
International media inquiries:
Richard Hayhurst, Schwartz Commuications UK Limited
RHayhurst@schwartz-pr.co.uk
(0)7950 878 218
This information is subject of the disclosure requirements acc. to §5-12 vphl
(Norwegian Securities Trading Act)
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