PCI Biotech: First patient dosed fimaCHEM Phase I ext

11.08.2017 kl 08:22

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Oslo, 11 August 2017 - PCI Biotech (OSE: PCIB), a cancer focused
biopharmaceutical company, today announced that the first patient has been dosed
in the fimaChem Phase I extension study with the objective to evaluate safety
and tolerability of repeated treatments with fimaChem in patients with
inoperable perihilar bile duct cancer.

A Phase I study, including 16 patients, was completed in 2016 with early
promising signs of tumour responses and encouraging emerging overall survival
data, based on a single fimaChem treatment. In order to further optimise the
treatment regimen in Phase II, a Phase I extension study is initiated with the
objective to evaluate safety and tolerability of repeated treatments with
fimaChem. The second fimaChem treatment will be done 3-4 months after the
initial treatment. The Phase I extension study will include a minimum of 6
evaluable patients. The extension study will run in parallel with the ongoing
regulatory interactions and other preparatory activities for a potential pivotal
Phase II study.

The first patient in the Phase I extension study was dosed at the University
Hospital Frankfurt, Germany. Prof. Dr. med. Jörg Trojan, principal investigator,
commented: "Bile duct cancer is a devastating disease with a very clear need of
better treatment methods. fimaChem represents a novel local treatment approach
for inoperable perihilar bile duct cancer patients and a single treatment with
the technology has already shown promising early signs of efficacy compared to
standard treatment options. It is exciting to explore whether these results can
be further improved by repeated fimaChem treatments and I look forward to
working with my fellow investigators on this study."

Per Walday, CEO of PCI Biotech, said: "We appreciate our investigators'
dedication to patients who are underserved with currently available treatment
options. We are strongly dedicated to advancing the development of fimaChem for
inoperable bile duct cancer patients in need of more effective local