Successful Investigational New Drug (IND) application

Posted on Dec 14, 2016

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.