PCI Biotech: Update on the RELEASE trial
24 Enero 2022 - 02:00PM
PCI Biotech: Update on the RELEASE trial
Oslo (Norway), 24 January 2022 – PCI Biotech
(OSE: PCIB), a cancer focused biopharmaceutical company, today
announced that the company has decided to stop the RELEASE study
and focus their drug development efforts on the promising
immunotherapy opportunities with both fimaVacc and fimaNAc
assets.
The decision to stop the RELEASE study is based
on recent randomised Phase III clinical trial results presented at
the American Society of Clinical Oncology Gastrointestinal Cancer
Symposium (ASCO GI, January 20-22, 2022) from the TOPAZ-1 study,
demonstrating that a combination of immune checkpoint inhibition
with gemcitabine and cisplatin provides a significant survival
benefit to patients with advanced biliary tract cancer compared
with placebo plus gemcitabine and cisplatin. These results are
expected to rapidly change the first line standard treatment for
patients with unresectable perihilar or distal bile duct cancer,
which is the intended patient population of the RELEASE trial. Such
a change in the standard of care treatment will render the RELEASE
trial challenging to complete and potentially inadequate for
approval and will significantly diminish the opportunity for PCI
Biotech’s treatment approach in this patient population.
The impact on the RELEASE trial of the recent
clinical trial results presented at ASCO GI has been discussed with
key opinion leaders, confirming an expected rapid change and early
adoption of immunotherapy plus chemotherapy as the new standard of
care treatment for the RELEASE trial’s target population.
Per Walday, CEO of PCI Biotech said: “The
significant survival benefit from the combination of immunotherapy
with chemotherapy is great news for patients. Previous results from
studies with immunotherapy in extrahepatic bile duct cancer have
not been compelling, and therefore a significant benefit on overall
survival in this population was not expected. Stopping RELEASE was
a hard decision to make, but it is necessary to act decisively when
the competitive landscape shifts. The RELEASE trial has been a
tremendous effort, not least by the enrolled patients, the clinical
sites, and our investors, willing to contribute to the benefit of
future patients and their relatives.
PCI Biotech’s cash position at year-end 2021 is
around NOK 115 million, and we will now focus on a cost-efficient
closing process of RELEASE and bringing our promising fimaVacc
vaccination technology forward as lead asset, and further develop
fimaNAc in the emerging field of nucleic acid therapy”.
The RELEASE trial enrolled a total of 41
patients, of which around 30% will continue to receive the study
treatments for a duration of up to six months. This should enable a
swift wind-down of RELEASE, allowing PCI Biotech to reallocate
resources to the other drug development programmes. The company
will analyse the results of RELEASE and evaluate how these can be
utilised for fimaChem going forward.
PCI Biotech will in due course communicate more
information on the next steps for the promising fimaVacc and
fimaNAc assets. The fimaVacc technology with a peptide-based
vaccine is planned to enter a Phase II proof-of-concept development
stage in cancer patients, following the encouraging immune response
results in Phase I. Detailed plans for the further development of
the fimaNAc asset have been prepared, supported by strong
preclinical results in the emerging field of nucleic acid
therapeutics.
***
PCI Biotech will host a webcast at 14:00 CET
(local time) on Tuesday, January 25, elaborating on the strategic
decision to stop RELEASE including a Q&A session. The webcast
will be hosted by CEO Per Walday, CMO Amir Snapir and CFO Ronny
Skuggedal. The Chairman of the Board, Hans Peter Bøhn will also be
present. The webcast will be held in English and can be accessed
through this link
https://channel.royalcast.com/hegnarmedia/#!/hegnarmedia/20220125_2.
There will be a Q&A session at the end of
the webcast and written questions can be posted to
post@pcibiotech.com prior to the event or via the webcast console
during the event. For those who intend to ask verbal questions
please see the dial-in details below.
Norway +47 2195 6342 / Sweden +46 (0)40682 0620
/ Denmark +45 7876 8490 / United Kingdom +44 2037 696 819 / United
States +1 646 787 0157. If your country is not listed, we
recommend that you use the dial-in details for UK.
When prompted, provide the confirmation code or
event title.
Confirmation Code:
436187
Event title: PCI Biotech conference call
If you plan to use this facility, please join
the event 5-10 minutes prior to the scheduled start time using the
dial-in numbers. A line mediator will provide information on how to
ask questions.
For further information, please
contact: Per
Walday, CEO Email:
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 considered to be inside
information pursuant to the EU Market Abuse Regulation and is
subject to the disclosure requirements pursuant to section 5-12 of
the Norwegian Securities Trading Act. This stock exchange
announcement was published by Ronny Skuggedal, CFO, PCI Biotech
Holding ASA, on 24 January 2022.
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