REG - CRISM Therapeutics - GMP Manufacture of ChemoSeed

CRISM TherapeuticsAnnouncement

12/08/2025 07:00

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RNS Number : 8754U  CRISM Therapeutics Corporation  12 August 2025

 

12 August 2025

 

 

CRISM Therapeutics Corporation

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

 

 

GMP Manufacture of ChemoSeed for Phase 2 Clinical Trial in Glioblastoma

 

CRISM Therapeutics (AIM: CRTX), the innovative UK drug delivery company
focused on the localised delivery of chemotherapy drugs, announces the
initiation of production of a clinical batch of ChemoSeed, its proprietary
sustained-release implant containing irinotecan, under Good Manufacturing
Practice (GMP).

 

This clinical batch will be produced for the Company's upcoming open-label
Phase 2 safety and efficacy trial evaluating ChemoSeed administered directly
into the resection margin in patients with surgically resectable glioblastoma.
US-based ProMed Pharma LLC, a Contract Development and Manufacturing
Organisation ("CDMO"), will produce the clinical batch.

 

The start of production marks a critical step toward first patient dosing,
expected in Q1 2026, and underscores CRISM's commitment to addressing the
significant unmet need in glioblastoma, a highly aggressive brain cancer with
poor prognosis and limited effective treatment options.

 

The Phase 2 study is designed to evaluate both safety and efficacy following
direct administration of ChemoSeed into the tumour resection margin, with the
goal of delivering a local high-dose of chemotherapy over a sustained period
of time, while minimising systemic toxicity. This innovative approach builds
on positive preclinical and early clinical data and has the potential to
redefine the standard of care in post-surgical glioblastoma management.

 

Andrew Webb, Chief Executive Officer of CRISM Therapeutics, commented:
"Initiating GMP manufacturing of ChemoSeed for our upcoming Phase 2 trial is
an important step towards bringing a potentially transformative therapy to
glioblastoma patients. This achievement reinforces CRISM's leading position in
the localised and sustained delivery of chemotherapeutics and advances our
mission to improve outcomes in some of the most challenging cancers."

 

Jim Arps, Director of Business Development at ProMed Pharma LLC, commented:
"We are proud to support CRISM Therapeutics in the GMP manufacture of
ChemoSeed for their innovative glioblastoma program. Our team is committed to
ensuring timely and compliant production of this novel treatment, which
represents a promising new approach to post-surgical cancer treatment."

 

The Company will provide further updates on its Clinical Trial Application,
clinical site activation and patient enrolment timelines in due course.

 

 

 

-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.

 

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

 

The Company's LEI is 213800XFW6MKVCHHPW88.

 

About ProMed Pharma

ProMed Pharma specializes in the molding and extrusion of drug-loaded
silicones, thermoplastics, and bioresorbable materials, leveraging this
expertise to manufacture long-term implants and combination devices under
cGMP.  Working with both established and early-stage companies, we utilize
robust manufacturing processes for controlled release of APIs utilizing a
variety of materials.  From clinical trial materials to commercial products,
ProMed supports pharmaceutical and medical device companies developing
controlled release formulations including subcutaneous, orthopedic,
cardiovascular, and ophthalmic implants, intravaginal rings, and
steroid-eluting combination components.  The company has facilities in
Plymouth and Maple Grove, Minnesota.

 

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

 

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