PCI Biotech: Successful Investigational New Drug (IND) application




Oslo, December 14, 2016 - PCI Biotech (OSE: PCIB), a cancer focused
biopharmaceutical company, reported today that it has received clearance by the
United States Food and Drug Administration (FDA) to include patients in the USA
in its Phase II clinical programme for fimaporfin (Amphinex®).

Fimaporfin is in clinical development for inoperable bile duct cancer and the
opening of the IND is in accordance with the previously communicated plan to
expand the bile duct cancer programme to the USA following the promising early
signs of efficacy in Phase I.

About PCI Biotech
PCI Biotech is a biopharmaceutical company focusing on development and
commercialisation of novel therapies for the treatment of cancer through its
innovative photochemical internalisation (PCI) technology platform.  PCI is
applied to three distinct anticancer paradigms: fimaChem (enhancement of
chemotherapeutics for localised treatment of cancer), fimaVacc (T-cell induction
technology for therapeutic vaccination), and fimaNAc (nucleic acid therapeutics
delivery).

Photochemical internalisation induces triggered endosomal release that is used
to unlock the true potential of a wide array of therapeutic modalities. The
company's lead fimaChem programme consists of a clinical Phase I/II clinical
study in bile duct cancer, an orphan indication with a high unmet need and
without approved products.  fimaVacc applies a unique mode of action to enhance
the essential cytotoxic effect of therapeutic cancer vaccines, which works in
synergy with several other state-of-the-art vaccination technologies.  fimaNAc
utilises the endosomal release to provide intracellular delivery of nucleic
acids, such as mRNA and siRNA therapeutics, thereby addressing one of the major
bottlenecks facing this emerging and promising field.

Contact information:
PCI Biotech Holding ASA, Ullernchausséen 64, N-0379 Oslo, Norway.
www.pcibiotech.com
Per Walday, CEO, pw@pcibiotech.no, Mobile: +47 917 93 429.

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