Successful completion of the fourth dose group in the Amphinex® study with continued strong tumour response. Further dose escalation is not needed.
Oslo, 23 September 2010 - PCI Biotech reported today that it has completed the
treatment of the fourth dose group in the phase I/II study of the combination
product PC-A11, with its proprietary photosensitiser Amphinex® used in
combination with the cytotoxic agent bleomycin in cancer patients. The clinical
results from the previous dose groups were confirmed also at the fourth dose
level, with strong tumour response in all three patients and complete clinical
regression of treated tumours observed in two of the patients within a few weeks
of treatment.
Significant photosensitivity in normal skin, as well as ulceration of treated
areas, has been observed in patients at the fourth dose level. The primary
objective of the phase I/II study, i.e. dose-limiting toxicity, is thus reached
and no further dose escalation is therefore necessary. The ulceration of treated
target areas at the fourth dose level has complicated the evaluation of tumour
response, but it has been concluded that complete clinical regression was
achieved in two of the patients. Strong tumour response was reported also on the
third patient, but tumour recurrence was observed at the three months follow-up
visit.
To date fourteen patients have been given a single photochemical internalisation
(PCI) treatment with PC-A11 at increasing dose levels of Amphinex®. The study is
performed at University College Hospital (UCH) in London. Complete clinical
regression of all evaluable treated tumours was observed within a few weeks of
treatment in thirteen of the patients, although one patient died of the
underlying disease before complete clinical regression could be achieved and
another patient had tumour recurrence at the three months follow-up visit.
Patients with osteosarcoma (1) and squamous cell carcinoma (9) of the Head &
Neck, adenocarcinoma of the breast (3), and malignant skin adnexal tumour (1)
have been included and the effectiveness of the PCI treatment with PC-A11 seems
to be similar across all cancers treated so far. The PCI technology could
therefore potentially be used for local treatment of several different cancers.
Apart from the photosensitivity observed at the fourth dose level, six serious
adverse events have been recorded; however not deemed drug-related by the
investigator.
To complete the study, 6 additional patients will be treated at the selected
therapeutic dose. Inclusion of these patients is expected to be completed in
2010.
When activated by light, Amphinex®( )promotes effective local delivery of a
variety of therapeutic molecules, such as bleomycin, through triggered endosomal
release. The primary objective of the present study has been to determine the
maximum tolerated dose of Amphinex®, in PCI treatment with the combination
product PC-A11, which also contains bleomycin. Secondary objectives include
assessment of the antitumor activity of the treatment, as well as the
pharmacokinetics of Amphinex(®). Preliminary analysis of the pharmacokinetic
data indicates that Amphinex® has a half-life in blood of 14 - 21 days,
depending on dose. Amphinex® also seems to be present in the skin for a
prolonged period, but is barely detectable 3 months after administration. The
absence of other drug related side effects than the observed photosensitivity at
the highest dose in the study, suggests that the slow kinetics does not impose
any major safety concerns.
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 Amphinex® and
thereafter the therapeutic drug to be specifically delivered to the diseased
cells. When these are illuminated the cells' endosomes are ruptured to allow
successful intracellular delivery of the drug.
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.
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 is with the combination product PC-A11, which
combines 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
This information is subject of the disclosure requirements acc. to §5-12 vphl
(Norwegian Securities Trading Act)
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