Oslo (Norway), 8 April 2019 - PCI Biotech (OSE: PCIB), a cancer focused
clinical-stage company developing innovative therapeutics that address
significant unmet medical needs today announced final confirmation of successful
safety read-out for the Phase I Extension study in inoperable bile duct cancer
patients which currently are left without effective local treatment options. The
appointed Cohort Review Committee (CRC) completed a formal review confirming the
Company's preliminary report that no adverse reactions have been reported that
would limit the delivery of up to two fimaChem treatments in the pivotal RELEASE
study with registration intent. The Phase I Extension study is now completed and
recruitment will be formally closed.
The clinical data from the Phase I Extension study include a total of seven
patients receiving fimaChem treatment and five of these received two treatments.
Three of the five patients that received two fimaChem treatments had measurable
disease at baseline and one of these had an overall partial tumour response
according to RECIST at 6 months, one had stable disease and one had progressive
disease due to the appearance of new lesions.
A post-study follow-up of the patients is ongoing. Five patients were alive at
last censoring (December 2018 - mid-February 2019), which all had been treated
with two fimaChem procedures. Patient numbers are limited and it is too early to
put any significance to the emerging survival data with 5 of 7 patients still
being alive, but currently this translates to an interim median Overall Survival
of approximately 12 months including all 7 patients, i.e. similar to best
comparable published data on gemcitabine/cisplatin treatment alone.
Per Walday, CEO of PCI Biotech, said: "With this positive safety clearance for
repeated treatments, PCI Biotech is now fully focused on execution of the
pivotal phase and we are eager to see the benefits fimaChem hopefully can
provide to the patients in need of better local treatment options."
The pivotal RELEASE study has the potential of accelerated/conditional marketing
approval as a first-line treatment given the rare disease status and high unmet
medical need. Based on today's positive safety data the RELEASE study will be
initiated with up to two fimaChem treatments and include a seamless safety
review by an Independent Data Monitoring Committee (IDMC) when eights patients
have completed two treatments.
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 PFS followed by 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 RELEASE study is expected to start during the first half of 2019; the
interim analysis of PFS and objective response rate (ORR) for potential
accelerated/conditional marketing approval is expected to be available
approximately 36 months after study initiation, while the final analysis is
expected approximately 50 months from initiation. The pivotal study will be
executed in clinical sites that first will open in Europe, followed by a roll-
out in the U.S.
Contact information:
Per Walday, CEO
pw@pcibiotech.no (mailto:pw@pcibiotech.no)
Mobile: +47 917 93 429
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 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 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)
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.