PCI Biotech receives positive opinion for Orphan Drug Designation of fimaporfin for treatment of cholangiocarcinoma in EU
Oslo, 25 July 2016 - PCI Biotech (OSE: PCIB), a cancer focused biopharmaceutical
company today announced that it has received a positive opinion from the
European Medicine Agency's (EMA) Committee for Orphan Medicinal Products (COMP)
for its lead product candidate, fimaporfin, for the treatment of
cholangiocarcinoma (bile duct cancer). COMP's positive opinion is subject to
decision by the European Commission for Orphan Designation.
Fimaporfin (Amphinex(TM)) is in clinical phase I/II development for inoperable
bile duct cancer, a disease without approved medicinal treatment and a high need
of better local treatment alternatives.
About bile duct cancer (cholangiocarcinoma)
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 results and has become standard
treatment in some regions, but there is still a need for better treatments to
increase overall survival and quality of life.
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 internalisation
(PCI) technology. The PCI technology works by inducing triggered endosomal
release and may be used to unlock the true potential of a wide array of
therapeutic modalities, such as small molecules, vaccines and nucleic acids.
The company has a clinical Phase I/II program in bile duct cancer. The company
is also developing PCI as a vaccination technology. When applied in the emerging
field of cancer immunotherapy, PCI can be used to enhance the important
cytotoxic effect of therapeutic cancer vaccines. The PCI technology is also very
well suited for intracellular delivery of nucleic acids, such as RNA
therapeutics. By releasing nucleic acid compounds from endosomes where they are
trapped following administration, PCI addresses one of the major bottlenecks
facing this emerging and exciting field. PCI Biotech follows a strategy to
create value by improving the effect of existing cancer drugs and by realising
the large potential in new therapeutics.
Contact information:
PCI Biotech Holding ASA, Ullernchausséen 64, N-0379 Oslo, Norway.
www.pcibiotech.com
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.
[HUG#2030556]