Oslo (Norway) – PCI Biotech (OSE: PCIB), a clinical-stage biopharma company developing innovative therapeutics that address significant unmet medical needs in cancer today announced that the first US patient has been enrolled into the fimaChem pivotal RELEASE study with registration intent in inoperable bile duct cancer patients. The RELEASE study spans across Europe, USA and Asia, with patient enrolment initiated in all continents.
Per Walday, CEO, said: “It is reassuring to see screening activity and enrolment picking up across the geographies of the RELEASE study, despite Covid-19 still having an impact on the healthcare systems. We are focused on optimal execution of the RELEASE study, to bring a new treatment option to a patient group with a high unmet medical need.“
Per Walday, CEO
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About the RELEASE study
The pivotal RELEASE study design 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 study programme consists of a single open randomised two-arm study with 186 patients (93 patients per arm), having a control arm with the standard of care (SoC) treatment of up to eight cycles of the 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 objective response rate (ORR), with the potential of accelerated/conditional marketing approval. In addition, the study 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. The study is done at clinical sites across Europe, USA and Asia.
About PCI Biotech
PCI Biotech is a biopharmaceutical late stage clinical development 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 programme fimaChem consists of a pivotal 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. fimaNAcutilises 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.
For further information, please visit: www.pcibiotech.com