REG - CRISM Therapeutics - Clinical Trial Update

CRISM' TherapeuticsAnnouncement

31/03/2025 07:15

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RNS Number : 8631C  CRISM Therapeutics Corporation  31 March 2025

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31 March 2025

 

 

CRISM Therapeutics Corporation

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

 

Clinical Trial Update

 

CRISM Therapeutics Corporation (AIM: CRTX), the innovative UK drug delivery
company focused on the localised delivery of chemotherapy drugs, provides a
positive update regarding its clinical trial authorisation ("CTA") application
to evaluate irinotecan ChemoSeed ("ChemoSeed") in patients with  high grade
glioma.  CRISM has been working with the Medicines and Healthcare products
Regulatory Agency ("MHRA") to finalise the design of the first in-human trial
of ChemoSeed and is pleased to confirm it has received positive written
scientific advice from the MHRA on the development, clinical trial programme
and potential Market Authorisation Application for the commercialisation of
ChemoSeed.

The written advice confirms that further preclinical toxicology studies will
not be required, which will significantly reduce the cost and time of the
development work. The Company had previously estimated a cost of approximately
£400,000 to conduct the toxicology studies.

In addition, the MHRA agreed that there is a biological basis supporting the
benefits of  ChemoSeed  and that  more drugs and methods of delivery are
needed for this disease.  MHRA was supportive of CRISM's novel dose
escalation study for ChemoSeed, confirming that the trial design was
appropriate for a Phase 2 clinical trial.  The MHRA  provided
recommendations to improve aspects of the clinical trial to make it more
suited to achieving potential market authorisation. The Company is now
progressing these recommendations, with support and advice from its contract
research organisation, Aixial, and its medical advisers.  The Company expects
to finalise its CTA application for submission in H1 2025 and to begin
clinical trials of ChemoSeed in Q4 2025, subject to MHRA and other external
regulatory organisations meeting expected review times.

The Company has also appointed Ryan LLC, which has a specialisation in
accessing grant funding, to assist CRISM secure grant funding specifically for
this clinical trial.  Ryan has an excellent track record in achieving
successful grant applications and has already identified opportunities for
which ChemoSeed is likely to qualify.

Commenting on the MHRA guidance, CRISM CEO Andrew Webb said: "We are pleased
that the MHRA has confirmed that our trial design is appropriate for a Phase 2
clinical trial in patients with  high grade glioma without the need for
further toxicology studies. The MHRA confirmed the need for more drugs and
methods of delivery in this disease where there remains a significant lack of
treatment options. The written advice from the MHRA is well received, and we
are working through the recommendations on ways to improve the trial design
with our medical advisers and Aixial ahead of submitting our CTA.
Additionally, we look forward to working with Ryan in order to secure grant
funding for this trial."

 

Dr. Valentina Zhukova-Harrill, Chief Medical Officer at Aixial, added: "We are
proud to see Aixial's expertise playing a pivotal role in advancing the
clinical strategy for ChemoSeed. This collaboration marks a critical step
forward in addressing a significant unmet medical need, and we look forward to
contributing to the upcoming Phase 2 study."

 

 

-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.

CRISM is expects to submit a clinical trial application for ChemoSeed in
high-grade glioma in H2 2025.

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

For more information about Aixial, please visit: https://www.aixialgroup.com/
(https://www.aixialgroup.com/)

For more information about Ryan, please visit:
https://ryan.com/europe/practice-areas/innovation-funding/
(https://ryan.com/europe/practice-areas/innovation-funding/)

 

 

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