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PCI Biotech: Dose escalation in the bile duct cancer study completed with promising early signs of efficacy

Oslo, 22 January 2016 - PCI Biotech (PCIB) reported today that the treatment
evaluation of the fourth dose cohort in the Phase I/II study of fimaporfin
(Amphinex®) in patients with inoperable bile duct cancer has been completed.
The Cohort Review Committee (CRC) of clinical experts and company
representatives has recommended that the study progress into Phase II, based
on promising early signs of efficacy in the last cohorts.

The CRC has reviewed data from twelve patients that have completed the safety
evaluation window and no dose limiting toxicities or other safety concerns
have been reported thus far in the study. CRC's recommendation is based on
early promising signs of tumour response in the last dose cohorts (both
partial and complete responses), combined with experience from earlier
clinical studies with fimaporfin.

Coordinating Investigator, Dr. Richard Sturgess at Aintree, said: "Bile duct
cancer has a remarkable resistance to chemotherapy and these patients are
lacking good alternative treatment options. The combination of fimaporfin and
gemcitabine represents a new and innovative treatment concept that could
potentially produce significant clinical benefit. The results of the Phase I
part of the study are encouraging and I look forward to working with my
fellow investigators on the continuation of this study."

The Phase II part of the study will be slightly modified to draw on the
experiences gained from Phase I, as well as recommendations from the
investigators and PCI Biotech's Scientific Advisory Committee. Phase II will
commence when the amended protocol has been approved by regulatory
authorities and ethics committees.

Per Walday, CEO of PCI Biotech, said: "This is an important milestone for PCI
Biotech. We are confident that fimaporfin (Amphinex®) has potential to
provide clinical benefit in bile duct cancer, which is an orphan disease with
high need of new local treatment options. Fimaporfin fits well with the
treatment need of this disease, both with regard to the standard endoscopic
procedures and our technology's ability to enhance the recommended cancer

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 limited. 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 potential of a wide
array of therapeutic modalities, such as small molecules, vaccines and
nucleic acids.

The company currently has a bile duct cancer program in Phase I/II clinical
development. Bile duct cancer is an orphan indication without any approved
medicinal products and a high medical need for better local treatments. It is
an indication well suited for PCI treatment, with easy light access for
intraluminal surface illumination through routine endoscopic methods and an
active generic drug (gemcitabine) significantly enhanced by PCI.

The company is also developing PCI as a CTL (Cytotoxic T Lymphocyte) 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 by enhancing the MHC I antigen
presentation of antigen presenting cells. 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 both of
existing cancer drugs and by realizing the large potential in new
therapeutics, including therapeutic vaccines.

Contact information:
PCI Biotech Holding ASA, Ullernchausséen 64, N-0379 Oslo, Norway.
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.


This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: PCI Biotech Holding via Globenewswire


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