Lysaker, 6 February 2015 - PCI Biotech (PCIB) the Norwegian biopharmaceutical company, reported today that the treatment evaluation of the second 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 progresses 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 recently been expanded to also include metastatic patients, and 5 new hospitals have been opened for patient inclusion during 2014.
About bile duct cancer
Bile duct cancer originates in the bile ducts which drain bile from the liver into the small intestine. It is a rare cancer (an orphan disease) without approved chemotherapies and the development pipeline is weak. Annual incidence rates of 1-2 cases per 100,000 are seen in the Western world, but rates have been rising worldwide over the past several decades. The majority of cases present as inoperable and there is a high unmet need for improved treatment technologies.
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. 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.
For more information visit: www.pcibiotech.com
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