PCI Biotech Holding — Earnings Release 2016

Jan 22, 2016

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

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 therapy."

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.

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.

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