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.

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.