Update on ongoing Phase I/II study and on preparation for a Phase II/III study of PC-A11
Oslo, 21 December 2010 - PCI Biotech reported today that it has received
additional feedback from European Medicines Agency (EMA). Some important
questions have been clarified and the company continues the preparations for a
confirmatory Phase II/III study as planned. Interaction with EMA for final
agreement on the study design will continue in 2011.
The regulatory applications for the Phase II/III study will, as planned, be
based on an interim report of the 14 patients included in the completed dose-
escalating part of the ongoing Phase I/II study. All data entries necessary for
this report has already been made, and preparation of the interim report is
progressing as planned.
The company has previously reported that inclusion of patients was expected to
be finished in 2010. Due to internal issues at the hospital in London, UK,
patient inclusion of the last patients has been slow. As per today, 2 additional
patients have been included at the therapeutic dose level, and it has been
decided to keep the study open for inclusion of up to four additional patients
in 2011. The aim is to primarily include Head and Neck cancer patients. This
change is not expected to significantly delay the start of a confirmatory Phase
II/III study, as the regulatory applications are based on the interim report.
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
International media inquiries:
Richard Hayhurst, Schwartz Commuications UK Limited
RHayhurst@schwartz-pr.co.uk , Mobile: +44
(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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