REG - CRISM Therapeutics - Approval for phase 2 clinical trial

CRISM TherapeuticsAnnouncement

01/09/2025 07:00

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RNS Number : 3434X  CRISM Therapeutics Corporation  01 September 2025

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1 September 2025

 

 

CRISM Therapeutics Corporation

("CRISM", "CRISM Therapeutics" or the "Company")

 

Regulatory and Ethical Approval for Registration-Grade Phase 2 Trial of
irinotecan-ChemoSeed in Glioblastoma

CRISM Therapeutics Corporation (AIM: CRTX), a UK clinical-stage drug delivery
company focused on the localised and sustained delivery of chemotherapy drugs,
today confirms that it has received both regulatory approval from the UK
Medicines and Healthcare products Regulatory Agency (MHRA) and favourable
ethical opinion from a UK Research Ethics Committee (REC) to initiate its open
label registration-grade Phase 2 clinical trial of irinotecan-ChemoSeed™ in
patients with surgically resectable glioblastoma.

This dual approval marks a significant operational milestone and clears the
Company to commence the trial across selected UK clinical sites in Q1 2026, as
planned.

The approved study, titled "An Open-label Phase 2 Safety and Efficacy Trial of
Irinotecan ChemoSeed Administered Directly into the Resection Margin in
Patients with Surgically Resectable Glioblastoma", is designed to assess the
safety, tolerability, and efficacy of irinotecan-ChemoSeed, CRISM's
proprietary, biodegradable implant technology delivering sustained-release
irinotecan directly into the tumour resection margin following surgical
removal of the glioblastoma tumour. The trial has been designed in alignment
with regulatory expectations for future marketing authorisation submissions.

Key Highlights:

·      Regulatory (MHRA) and Ethical (REC) approval received

·      Trial confirmed to initiate in Q1 2026 at leading UK
neuro-oncology centres

·      Open-label format supports interim analysis, reporting of early
results and potential for expedited regulatory approval

·      ChemoSeed platform targets local recurrence with sustained,
localised chemotherapy

·      Registration-grade Phase 2 design supports pathway to marketing
authorisation and commercialisation.

Professor Chris McConville, Chief Scientific Officer of CRISM Therapeutics,
commented:

"We are delighted to have received both regulatory and ethical approval to
begin our Phase 2 study. This is a critical inflection point for CRISM as we
prepare to clinically validate our ChemoSeed platform in patients with
glioblastoma, an area of immense unmet need. With these approvals secured, we
are now in a position to move rapidly into trial activation and first patient
dosing. We believe the data from this study could serve as a foundation for
future regulatory submissions and commercial advancement."

Professor Garth Cruickshank, Emeritus Professor of Neurosurgery at the
University of Birmingham, and scientific advisor to CRISM, added: "This is a
very exciting development in the drive to treat one of the most complex
cancers. The technical innovation of putting the tumour killing drug
irinotecan into the tumour site at the time of the surgery offers the very
best chance to hit the tumour when it is at its smallest. The release process
at least covers the time until radiotherapy and or temozolomide are introduced
providing a much more powerful sustained antitumour assault. The local
deposition of drug already known to attack glioblastoma, avoids systemic side
effects, so no additional problems for patients. This approach safely enables
high antitumour concentrations without evidence of associated neurotoxicity.
Furthermore, the spectrum of patients likely to respond is greater than for
any gene targeted or existing immunotherapy. Patients and surgeons will surely
welcome such a pragmatic and truly practical step forward in treatment for
glioblastoma."

CRISM is working with its CRO, Aixial Group, to activate the first site in the
UK and start to enrol patients in Q1 of 2026. Further details of the trial are
included in the Submission of Clinical Trial Authorisation application to the
MHRA
(https://www.londonstockexchange.com/news-article/CRTX/submission-of-cta-application/17111717)
announcement on 01 July 2025.

 

-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           Vadim Alexandre                   CRISM@buchanancomms.co.uk

                                 Adam Cowl
 via Burson Buchanan             +44 (0) 20 3470 0470              +44 (0) 20 7466 5000

 

 

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
glioblastoma, 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 will initiate its registration-grade Phase 2 clinical trial of
irinotecan-ChemoSeed in patients with surgically resectable glioblastoma in Q1
2026.

 

For more information please visit: https://www.crismtherapeutics.com/
(https://www.crismtherapeutics.com/)

 

The Company's LEI is 213800XFW6MKVCHHPW88.

 

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