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within this announcement is deemed to constitute inside information
as stipulated under the Market Abuse Regulation (EU) No. 596/2014,
as incorporated into UK law by the European Union
(Withdrawal) Act 2018. Upon the publication of this announcement,
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domain.
20 December 2024
CRISM Therapeutics
Corporation
("CRISM",
"CRISM Therapeutics" or the "Company")
Appointment of Specialist
Clinical CRO
CRISM Therapeutics Corporation (AIM:
CRTX), the innovative UK drug delivery
company focused on the localised delivery of chemotherapy drugs,
announces that it has
appointed Aixial Group ("Aixial"), a specialist
clinical contract research
organisation ("CRO") to progress the Company's
Clinical Trial Authorisation ("CTA") application.
CRISM appointed Aixial, an
international CRO, to progress and finalise the Company's CTA
application for the Company's open label Phase 2 study of ChemoSeed
in patients with glioblastoma.
Glioblastoma, a rare disease, is the most
aggressive form of brain tumour with a median overall survival of
just 14.6 months, making it an area of major unmet medical need.
Aixial has significant experience of rare
diseases and brain tumour trials, both in the UK and
internationally, and has delivered more than 300 oncology studies
across multiple jurisdictions including the UK, EU, USA and Asia
Pacific. The Board considers that Aixial is best suited to serve
CRISM's requirements for an accelerated CTA application and
approval and they are currently in discussions with the Medicines
and Healthcare products Regulatory Agency ("MHRA") to obtain
scientific advice prior to the submission of the Company's Clinical
Trial Application for the Phase 2 study, scheduled for early
2025.
The appointment of Aixial also brings the
potential for study centres outside of the UK to be included in the
Phase 2 study, which would be of great value in assisting patient
recruitment and in the subsequent commercial pathway should the
study be successful.
The Company continues to work closely with the
University of Birmingham and the Tessa Jowell BRAIN MATRIX
scientific advisory committee is supportive of the clinical
evaluation of ChemoSeed in patients with primary brain cancer and
will promote the clinical trial to patients via their
network.
Commenting on the appointment of Aixial, CRISM CEO Andrew Webb
said: "We are delighted to be working with a well-established CRO
like Aixial on our CTA application. Operating across multiple
jurisdictions and with expertise in rare diseases such as
glioblastoma we believe that Aixial is the ideal strategic partner
for CRISM. We would like to thank the University of
Birmingham for its support and look forward to continuing
collaborating with the Tessa Jowell BRAIN
MATRIX."
Commenting on the agreement, Aixial Managing Director, Jonas
Möller said: "Aixial Group take great
pride in our extensive glioblastoma experience. Our
partnership with CRISM Therapeutics is a testament of our
commitment to advancing oncology research and our ability to
support innovative and impactful treatments such as
ChemoSeed.
"Leveraging the expertise of our operations teams and
glioblastoma subject matter experts, including Dr. Valentina
Zhukova-Harrill, Chief Medical Officer, we ensure every trial is
grounded in robust medical, operational, and regulatory excellence.
Aixial's deep understanding of complex oncology studies strengthens
our ability to deliver high-quality solutions for our partners and,
most importantly, for patients."
-Ends-
Enquiries:
|
Company
|
Nomad and
Broker
|
Financial
PR
|
|
CRISM Therapeutics
Corporation
|
S.P. Angel Corporate Finance
LLP
|
Burson
Buchanan
|
|
Andrew
Webb, CEO
Chris
McConville, CSO
|
Richard
Morrison
Adam
Cowl
|
Mark
Court / Jamie Hooper
CRISM@buchanancomms.co.uk
|
|
via
Burson Buchanan
|
+44 (0)
20 3470 0470
|
+44 (0)
20 7466 5000
|
About Aixial Group
Aixial Group is a Contract Research
Organization (CRO) with over 25 years of experience, dedicated to
delivering high-quality clinical research solutions globally. We
provide comprehensive support for clinical trials, with specialized
expertise in Oncology, Rare Diseases, and Central Nervous System
(CNS) disorders.
For more information please
visit: https://www.aixialgroup.com/
About CRISM Therapeutics Corporation
CRISM Therapeutics Corporation has
developed an innovative drug delivery technology to improve the
clinical performance of cancer treatments for solid tumours through
the local delivery of chemotherapy drugs.
ChemoSeed®, CRISM's lead product,
can be implanted directly into the tumour or the resection margin
following the removal of a tumour. This directs that therapeutic
concentrations of chemotherapy drugs reach the deep-seated tumour
tissue or cover the entire resection margin. In the case of
treating high-grade glioma, ChemoSeeds can be implanted during
surgery thereby bypassing the blood brain barrier, which prevents
other treatments from being able to reach the tumour and be
effective.
CRISM is scheduled to submit a
clinical trial application for ChemoSeed in high-grade glioma in
early 2025.
For more information please
visit: https://www.crismtherapeutics.com/
