PCI Biotech: First patient dosed in the fimaCHEM Phase I extension study
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
treatments."
Contact information:
Per Walday, CEO
pw@pcibiotech.no
Mobile: +47 917 93 429
About bile duct cancer and the fimaChem technology
The bile duct drains bile from the liver into the small intestine. Biliary tract
sepsis, liver failure and/or malnutrition and cachexia due to locoregional
effects of the disease are the most important causes of death. Currently,
surgery is the only curative option for these patients; yet the majority of the
tumors are inoperable at presentation. Inoperable patients are treated with
stenting to keep the bile duct open and with chemotherapy. The combination of
gemcitabine and cisplatin has shown promising activity and has become standard
treatment in most regions, but there is still a clear need for better treatments
to increase overall survival and quality of life. PCI Biotech's fimaChem
programme for bile duct cancer aims to deliver a local treatment approach to
patients that currently are without any approved drug options. Gemcitabine is
one of the drugs significantly enhanced by the fimaChem technology in
preclinical studies. Light access for fimaChem treatment is easy through
routinely used endoscopic methods enabling local enhancement of gemcitabine,
creating a very good fit to the technology.
About PCI Biotech
PCI Biotech is a biopharmaceutical company focusing on development and
commercialisation of novel therapies for the treatment of cancer through its
innovative photochemical internalisation (PCI) technology platform. PCI is
applied to three distinct anticancer paradigms: fimaChem (enhancement of
chemotherapeutics for localised treatment of cancer), fimaVacc (T-cell induction
technology for therapeutic vaccination), and fimaNAc (nucleic acid therapeutics
delivery).
Photochemical internalisation induces triggered endosomal release that is used
to unlock the true potential of a wide array of therapeutic modalities. The
company's lead fimaChem programme consists of a Phase I/II clinical study in
bile duct cancer, an orphan indication with a high unmet need and without
approved products. fimaVacc applies a unique mode of action to enhance the
essential cytotoxic effect of therapeutic cancer vaccines, which works in
synergy with several other state-of-the-art vaccination technologies. fimaNAc
utilises the endosomal release to provide intracellular delivery of nucleic
acids, such as mRNA and siRNA therapeutics, thereby addressing one of the major
bottlenecks facing this emerging and promising field.
For further information, please visit: www.pcibiotech.com
Forward-looking statements
This announcement may contain forward-looking statements, which as such are not
historical facts, but are based upon various assumptions, many of which are
based, in turn, upon further assumptions. These assumptions are inherently
subject to significant known and unknown risks, uncertainties and other
important factors. Such risks, uncertainties, contingencies and other important
factors could cause actual events to differ materially from the expectations
expressed or implied in this announcement by such forward-looking statements.
PCI Biotech disclaims any obligation to update or revise any forward-looking
statements, whether as a result of new information, future events or otherwise.
This information is subject to the disclosure requirements pursuant to section
5 -12 of the Norwegian Securities Trading Act.