REG - CRISM Therapeutics - Appointment of Specialist Clinical CRO

CRISM' TherapeuticsAnnouncement

20/12/2024 07:00

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RNS Number : 8363Q  CRISM Therapeutics Corporation  20 December 2024

 

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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                Richard Morrison                  Mark Court / Jamie Hooper

 Chris McConville, CSO           Adam Cowl                         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/
(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/
(https://www.crismtherapeutics.com/)

 

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