REG - CRISM Therapeutics - US Orphan Drug Designation Application

CRISM TherapeuticsAnnouncement

30/10/2025 07:00

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RNS Number : 4097F  CRISM Therapeutics Corporation  30 October 2025

30 October 2025

 

 

CRISM Therapeutics Corporation

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

 

Submission of Orphan Drug Designation Application to the FDA for
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,
is pleased to announce that it has submitted an application to the US Food and
Drug Administration ("FDA") seeking Orphan Drug Designation ("ODD") for its
lead programme, irinotecan-ChemoSeed™, for the treatment of glioblastoma.

Glioblastoma is a rare and aggressive form of brain cancer with extremely
limited treatment options and poor survival outcomes. The submission of this
application marks another step in CRISM's strategy to advance
irinotecan-ChemoSeed as a localised therapy for patients undergoing surgical
resection of glioblastoma.

The FDA's Orphan Drug Designation programme is designed to encourage the
development of medicines for rare diseases affecting fewer than 200,000
patients in the United States. If granted, ODD status would provide CRISM with
potential benefits including: seven years of US market exclusivity following
approval; tax credits for clinical research costs; waiver of FDA application
fees; and enhanced regulatory support and guidance throughout development.

CRISM has already been awarded an Innovation Passport for irinotecan-ChemoSeed
under the UK's Innovative Licensing and Access Pathway ("ILAP"), recognising
the therapy's potential to address the critical unmet need in glioblastoma.
ILAP provides access to enhanced regulatory collaboration and accelerated
assessment pathways in the UK. In addition, CRISM is exploring participation
in Project Orbis, the international regulatory collaboration led by the FDA to
speed up access to promising cancer treatments across major global markets.

The submission of the ODD application follows recent regulatory and ethical
approvals in the UK for CRISM's registration-grade Phase 2 clinical trial of
irinotecan-ChemoSeed in surgically resectable glioblastoma, which is expected
to begin dosing of patients in Q1 2026.

 

The Company's ODD application forms a key part of its global regulatory
strategy designed to unlock accelerated development and early market access
opportunities in both the US and UK.

Professor Chris McConville, Chief Scientific Officer of CRISM Therapeutics,
commented:
"Submitting our Orphan Drug Designation application to the FDA represents
another important step in CRISM's strategy. The US is the largest
pharmaceutical market globally, and we believe this application will add
further appeal to potential partners as we start to produce data from our
Phase 2 clinical trial next year. Together with our Innovation Passport under
ILAP and our potential alignment with Project Orbis, this application reflects
a global regulatory strategy to bring ChemoSeed to patients faster, starting
with glioblastoma."

-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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