Scandinavian ChemoTech’s Chief Medical Officer, Suhail Mufti, delivers clinical update

This is the second clinical update following the introduction of TSE (Tumour Specific Electroporation™) in the curative treatment line of Head and Neck (H&N) cancer at AIIMS Jodhpur. In this update, CMO Suhail Mufti provides insights into the long-term clinical study objectives and key milestones.

 

 

Clinical Trial Progress in University Hospital in Jodhpur India, non-sponsored trials:

 

1. Patient enrolment began as scheduled, following the Ethics Committee approval of the revised clinical study protocol, as publicly announced on November 29, 2023.
2. The latest protocol amendment added Arms B and C to the study, including patients with unresectable locoregional recurrence of Head and Neck (H&N) cancer. Arm B of the study protocol includes patients eligible for radiotherapy, while Arm C involves patients eligible for chemotherapy, targeted therapy, immunotherapy, or a combination with medical treatment. Arm A is unchanged and includes patients with recurrence after surgery, radiation and chemotherapy.
3. The delay in enrolment due to administrative changes at the research institution, which are beyond ChemoTech's control, are of course deeply regrettable. However, we are optimistic that these adjustments will ultimately benefit the research process. We appreciate your patience as we work through this and remain committed to moving the project forward efficiently.

 

The first patient under Arm B of the revised protocol has completed TSE therapy, marking the first time TSE was used before other second-line treatments. The study team reported a nearly 50% reduction in tumour size, allowing the patient to proceed with radiotherapy without needing surgery. A case study on this is being prepared by the research team.

 

Future targets for the AIIMS Trial

• Data collection and biomarker analysis in the ongoing clinical trial continues.
• A breast cancer protocol has been reviewed and is awaiting discussion by the Ethics Committee.
• AIIMS research teams has shown interest in pilot studies for deep-seated tumours. Updates will follow.
• A case series for routine cases outside the clinical trial at AIIMS is completed and under peer review. Further updates will be provided soon.

Clinical Strategy and Achievements

 

The clinical development goals for TSE extend beyond demonstrating its effectiveness in treating superficial tumours and providing palliative care. The current focus is on utilizing TSE in earlier, curative cancer treatments in combination with other therapies.

 

The table below highlights the key milestones achieved in translating the scientific knowledge of TSE into clinical practice, ensuring compliance with Regulatory Affairs and Good Clinical Practice (GCP) standards.

 

2015	ChemoTech launched TSE - Tumour Specific Electroporation™
2016	-          TSE first publication -          NOC in India, approval for the previous model of IQwave™ 2.0
2018	First clinical trial initiated in Malaysia
2021	-          The product, IQwave™ 3.0 CE approved for CE mark according to Medical Device Directive (Europe) MDD 93/42 -          Post Market Clinical Follow up (PMCF) study at AIIMS Jodhpur with immune biomarker analysis
2022	-          Two pancreatic cancer cases treated with a shown 50% mass reduction of tumour -          The company was certified according to ISO 13485:2016 Quality Management system Regulatory registration of IQwave™ 3.0 CE in Malaysia and in Ukraine approved. -          Malaysian Study ended prematurely due to the pandemic and was converted to a case series report. Report to be completed by the investigator
2023	Multi-centre study for validating immune effect and combinations
2024	For the first time, Tumour Specific Electroporation (TSE) has been employed with curative intent. Notably, traditional ablative technologies such as IRE have not been used in the same clinical setting as TSE. This breakthrough is attributed to TSE's unique multimodal mechanism of action, which enables a graded and gentle cytoreduction The revised clinical strategy for TSE therapy in India emphasizes prioritizing Large Government Oncology Institutions and University Hospitals, recognizing their central role as primary referral centres for patients requiring such specialized treatment. This strategic shift capitalizes on the concentrated patient flow to these oncology centres, optimizing resource allocation and enhancing patient access to targeted TSE therapy In India MD- 42 License (Stock & Sale in India) received in May 2024 Regulatory registration of IQwave 3.0 CE in Singapore approved March 2024

 

 

For further information please contact:

 

CMO Dr Suhail Mufti

Scandinavian ChemoTech AB, Medicon Village, Scheeletorget 1, SE-223 63 Lund, Sweden

Phone numbers: +46 (0)10 218 93 00

 

E-mail: [email protected]

 

 

Scandinavian ChemoTech AB (publ)

ChemoTech is a Swedish medical technology company based in Lund that has developed a patented technology platform to offer cancer patients access to a new treatment alternative, Tumour Specific Electroporation™ (TSE), available for treatment of both humans and animals. There are a large number of cancer patients whose tumours for various reasons cannot be treated by conventional methods but where TSE can be a solution. Therefore, the company continuously evaluates new opportunities and areas of application for the technology. ChemoTech's shares (CMOTEC B) are listed on Nasdaq First North Growth Market in Stockholm and Redeye AB is the company's Certified Adviser. Read more at: www.chemotech.se.