PCI Biotech: Update on regulatory interactions for the RELEASE trial
07 Diciembre 2021 - 11:45AM
PCI Biotech: Update on regulatory interactions for the RELEASE
trial
Oslo (Norway), 7 December 2021 – PCI Biotech
(OSE: PCIB), a cancer focused biopharmaceutical company, today
announced that the company has concluded on the interactions with
regulatory authorities in the US (US Food and Drug Administration,
FDA) and Europe (European Medicines Agency, EMA) held during 2H
2021.
The interactions with the FDA and EMA were
initiated to explore the opportunity for a modified study design to
address the retention risk in the control arm of the RELEASE study.
PCI Biotech argued that enrichment of the control arm of RELEASE
with external control data, using existing patient-level data from
past clinical trials and real-world data from a patient registry
for patients with extra-hepatic cholangiocarcinoma receiving
gemcitabine-cisplatin, could address the potential retention issue
and that this approach may also benefit recruitment. The company
has previously reported that initial responses from the authorities
suggested significant challenges for using external control data in
a pivotal trial of a first line treatment. The authorities have now
reiterated their position and given more granularity on their
concerns.
Both regulatory authorities recognised the
retention and recruitment challenges for RELEASE in bile duct
cancer, a rare disease with high unmet medical need. The
authorities’ main concern is that the proposed modification would
introduce a risk for uncontrolled bias. The feedback suggests that
the validity of external control data for inferential statistical
tests is not yet sufficiently corroborated for the settings of a
global pivotal trial with registration intent.
PCI Biotech acknowledges the feedback from the
authorities and has concluded not to further pursue adoption of
real-world data to supplement experimental control arm data in a
randomised first line setting under the current regulatory
environment. The company continue with full focus on RELEASE
assessing all opportunities to address retention and
recruitment.
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.
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
Contact
information: Per
Walday,
CEO pw@pcibiotech.noMobile:
+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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