Update on the ENHANCE study
Lysaker, June 3 2015 - PCI Biotech reported today that, following a strategic review of the company's assets, it has decided to stop the ENHANCE study and focus the company's resources towards the clinical bile duct cancer study and the promising immunotherapy opportunities offered by the PCI technology.
This decision was based on both strategic and clinical considerations. A recent review of the relevant market segment suggests a diminishing opportunity for Amphinex induced treatment with bleomycin in recurrent head and neck cancer, not least due to expected increased competition by emerging immunotherapies for this patient population. In addition, optimising the light dose for bleomycin-induced tumour ablation by interstitial illumination has turned more complicated than anticipated.
The promising early signs of tumour response seen in Phase I seems to translate well to the smaller cohort of patients in the ENHANCE study that are eligible for surface illumination. These patients respond as expected to the treatment, with a majority so far being durable complete responses. The company will evaluate how these results can be best utilised going forward.
The company will put increased resources into 1) the bile duct cancer study to accelerate development and 2) advancing the promising preclinical immunotherapy opportunities towards partnering and clinical development.
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 therapeutic potential of a wide array of modalities, such as small molecules, ADCs and siRNA.
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 significantly enhanced by PCI.
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 further information, please contact
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.