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

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.

 

This information is subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act.

 

NewsKristin Eivindvik