Successful completion of the third dose cohort in the study for patients with inoperable bile duct cancer

Lysaker, 18 August 2015 - PCI Biotech (PCIB) the Norwegian biopharmaceutical company, reported today that the treatment evaluation of the third dose cohort is completed in the phase I/II study of Amphinex®-induced PCI of gemcitabine followed by gemcitabine/cisplatin treatment in patients with inoperable bile duct cancer (cholangiocarcinoma). No safety concerns were observed at this dose Level.

The Cohort Review Committee of clinical experts and company representatives that evaluates the results and provides recommendation for the continuation of the study has recommended that the study progress into the next dose in accordance with the study protocol. Patients for the next dose cohort are currently being screened and will be treated with Amphinex as soon as possible.

Bile duct cancer is a rare disease and the company is working actively to increase the patient recruitment rate. The eligible patient population has been expanded to also include metastatic patients and further hospitals in selected European countries are being added to the study.

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 the Norwegian Radium Hospital, the PCI technology works by inducing triggered endosomal release and may be used to unlock the true potential of a wide array of therapeutic modalities, such as small molecules, vaccines and nucleic acids.

 The company currently has a bile duct cancer program in phase I/II clinical development. Bile duct cancer is an orphan indication without any approved medicinal products and a high medical need for better local treatments. It is an indication well suited for PCI treatment, with easy light access for intraluminal surface illumination through routine endoscopic methods and an active generic drug (gemcitabine) significantly enhanced by PCI.

The company is also developing PCI as a CTL (Cytotoxic T Lymphocyte) 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 by enhancing the MHC I antigen presentation of antigen presenting cells. When applied in 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