REG - CRISM Therapeutics - Submission of CTA Application

CRISM' TherapeuticsAnnouncement

01/07/2025 07:00

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RNS Number : 0868P  CRISM Therapeutics Corporation  01 July 2025

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1 July 2025

 

 

CRISM Therapeutics Corporation

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

 

Submission of Clinical Trial Authorisation application to the MHRA

 

First-in-human clinical trial of a novel treatment for brain tumours

 

CRISM Therapeutics Corporation (AIM: CRTX), the innovative UK drug delivery
company focused on the localised delivery of chemotherapy drugs, today
confirms the submission of a Clinical Trial Authorisation ("CTA") application
on 30 June 2025 to the UK Medicines and Healthcare products Regulatory Agency
("MHRA") for the Company's Phase 2 registration grade clinical study of
irinotecan ChemoSeed in resectable glioblastoma.

The study, titled 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 evaluate the safety,
tolerability, and efficacy of ChemoSeed, CRISM's proprietary biodegradable
implant technology, delivering irinotecan directly into the resection margin
following surgical removal of glioblastoma tumours.

The Phase 2 trial will enrol patients with both recurrent and newly diagnosed,
surgically resectable glioblastoma and aims to assess whether localised,
sustained delivery of irinotecan immediately after tumour resection can
improve outcomes compared with conventional systemic chemotherapy by targeting
residual tumour cells at the site of highest risk of recurrence, when they are
at their lowest volume and most vulnerable to chemotherapy.

The trial, which is open label, has been designed in two parts. The first part
is a dose escalation study in recurrent glioblastoma using an increasing
number of irinotecan ChemoSeeds in a total of 12 patients. Pending regulatory
approval from the MHRA, the first patient is expected to be dosed in Q1 2026
and this part of the trial is expected to report in Q1 2027.

The second part of the trial will use the optimum dosage from part one of the
trial and will include newly diagnosed and recurrent glioblastoma patients
divided across two arms, a control arm and a treatment arm. It is expected
that a total of 135 patients will be treated in this part of the trial at
multiple specialist neuro-oncology centres across the UK,  with 90 patients
in the treatment arm and 45 in the control arm.

The second part of the trial is expected to start in H1 2027 and to report out
approximately 2.5 years later.

The primary endpoint of the trial is progression free survival, and the
secondary endpoint is median overall survival.

 

Prof. Chris McConville, Chief Scientific Officer at CRISM Therapeutics,
commented: "Submitting this CTA marks a significant milestone in the clinical
development of ChemoSeed. By delivering irinotecan precisely where it is
needed, in the resection margin, when the tumour is at its most vulnerable and
treated over a sustained period of time, this study aims to provide a new
therapeutic strategy for glioblastoma, a cancer with persistently poor
prognosis despite standard-of-care interventions."

Andrew Webb, CEO of CRISM Therapeutics, added: "This first-in-human trial
builds on compelling preclinical data and reflects our commitment to
redefining solid tumour treatment through sustained localised therapy. We are
hopeful that this Phase 2 study will demonstrate the clinical impact of our
ChemoSeed drug delivery platform in one of the most urgent areas of need in
neuro-oncology and bring a new treatment to patients affected by this
devastating disease."

 

-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 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.

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

 

 

 

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