Preliminary confirmation of safety read-out from the fimaChem Phase I extension study in bile duct cancer
Oslo (Norway), 20 December 2018 – PCI Biotech (OSE: PCIB), a cancer focused biopharmaceutical company today announced preliminary confirmation that the safety endpoint has been reached in the Phase I extension study without the report of any adverse reactions which would limit the proposed plan of including up to two fimaCHEM treatments in the pivotal study. The final confirmation of successful safety read-out is pending completion of site monitoring and a formal review by the appointed Cohort Review Committee (CRC). Recruitment of patients will be kept open until the CRC has completed their review and confirmed that the safety endpoint has been reached.
Per Walday, CEO of PCI Biotech, comments: The decision to start the pivotal study was based on the initial positive data with a single treatment and we believe that allowing for up to two fimaChem treatments may provide additional benefits to patients. Today’s positive safety notification suggests that it is safe to initiate the pivotal study with up to two treatments with fimaCHEM and our full focus is now on initiation and delivery of the pivotal study, which remains on track to start first half 2019.
About the fimaChem bile duct cancer program and the upcoming pivotal study
The ongoing Phase I study including the dose-escalation and extension part with fimaCHEM for the treatment of inoperable extrahepatic bile duct cancer aims to demonstrate the candidate’s safety and tolerability as well as finding the right dosing regimen for further clinical studies. The promising early signs of efficacy in the dose-escalating part of the study were based on a single fimaCHEM treatment in addition to the current standard of care (SoC) as background treatment. The Phase I extension study was initiated with the objective to determine safety and tolerability of repeated treatments with fimaCHEM, as this may well increase the encouraging signs of efficacy. In this study, the second fimaChem treatment is administered approximately three to four months after the initial treatment.
The design of the upcoming Pivotal study is based on the outcome of meetings with the two leading regulatory authorities European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA). The pivotal study programme consists of a randomised two-arm study with 186 patients (93 patients per arm), having a control arm with the SoC combination treatment of up to eight cycles of chemotherapies gemcitabine and cisplatin, and an experimental arm with up to two fimaCHEM treatments in addition to SoC. The study’s primary endpoint is progression free survival (PFS), with overall survival (OS) as a key secondary endpoint. The study includes an interim analysis of PFS followed by analysis of objective response rate (ORR), with the potential of accelerated/conditional marketing approval. This is expected to be available approximately 36 months after study initiation, while the final analysis is expected at approximately 50 months from initiation. The study also contains several other secondary endpoints that provide the opportunity to generate robust comparative data of importance for market acceptance of fimaCHEM as a first-line treatment for inoperable bile duct cancer.
Per Walday, CEO
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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 clinical Phase I/II 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 RNAi 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.