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.”
Per Walday, CEO
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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.
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.