PCI Biotech: Successful Investigational New Drug application (IND) review for Amphinex




Lysaker, 20 January 2015 - PCI Biotech announces that it has today received
clearance by the United States Food and Drug Administration (FDA) to include
patients in the USA in its phase II clinical programme for Amphinex.

Amphinex is in development as a new local treatment for recurrent head and neck
cancer and the phase II program has already been initiated in Europe. "This is
an important milestone for us that acknowledges our data on file for Amphinex
and may enable us to accelerate our phase II programme through expansion in the
USA." says Per Walday, CEO of PCI Biotech.

About PCI Biotech
PCI Biotech is a cancer focused biopharmaceutical company headquartered in
Norway and listed on the Oslo Stock Exchange (Axess). The company is developing
therapeutic products based on its proprietary photochemical internalization
(PCI) technology. Originating from world leading research at eh Norwegian Radium
Hospital, the PCI technology works by inducing triggered endosomal release and
may be used to unlock the  true  therapeutic  potential  of a wide array of
modalities, such as small molecules, ADCs and siRNA. Two programs are currently
in clinical development in patient populations with a high unmet medical need;
recurrent head & neck cancer (phase II) and bile duct cancer (phase I/II).

The company is also developing PCI as a CTL induction technology for therapeutic
and prophylactic vaccination. It has been demonstrated both in vivo and ex vivo
that PCI significantly increases the number of activated antigen-specific CTLs
(Cytotoxic T Lymphocytes) by enhancing the MHC I antigen presentation of antigen
presenting cells. When applied more specifically to the emerging field of cancer
immunotherapy, PCI can be used to enhance the important cytotoxic effect of
therapeutic cancer vaccines. PCI Biotech follows a strategy to create value by
improving the effect both of existing cancer drugs and by realizing the large
potential in new therapeutics, including therapeutic vaccines.

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
Ronny Skuggedal, CFO, rs@pcibiotech.no, Mobile: +47 940 05 757

This information is subject to the disclosure requirements pursuant to section
5-12 of the Norwegian Securities Trading Act.


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