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trial and recommends that the trial continues with up to two fimaChem treatments
as stated in the protocol.
The ongoing pivotal RELEASE trial with registration intent was initiated with a
planned safety review for the first eight patients receiving two fimaChem
treatments. In the previously completed Phase I study a total of five patients
received two treatments and now with additional eight patients reviewed for
safety after two treatments, the RELEASE trial seamlessly continues to enrol
patients for up to two fimaChem treatments.
Per Walday, CEO of PCI Biotech, said: “With this positive initial safety
clearance for repeated treatments, PCI Biotech continue to focus on execution of
the pivotal trial and we are eager to see the benefits fimaChem hopefully can
provide to the patients in need of better local treatment options. So far, a
clear majority of patients eligible to receive two treatments in RELEASE opted
for the second treatment, which is an early encouraging sign on the
acceptability of the treatment modality, both from a patient- and clinician
perspective.”
The IDMC consists of international experts in bile duct cancer and medical
statistics and is chartered to monitor the safety of participants in the RELEASE
trial. The primary purpose of the IDMC is the protection of participants in the
trial and the maintenance of trial integrity. The IDMC recommendation is based
on a review of the available trial safety data, including data from eight
patients that had undergone two fimaChem treatments.
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 perihilar and
distal 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.
For further information, please visit: www.pcibiotech.com
(http://www.pcibiotech.com)
Contact information:
Per Walday, CEO
pw@pcibiotech.no
Mobile: +47 917 93 429
Forward-looking statements
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.
This information is subject to the disclosure requirements pursuant to section
5-12 of the Norwegian Securities Trading Act.
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