Scandinavian ChemoTech’s Chief Medical Officer, Suhail Mufti, provides an update on the clinical development and strategy of Medical Affairs

After the entry of TSE (Tumour Specific Electroporation™) in the curative lines of therapy for Head and Neck (H&N) cancer at AIIMS Jodhpur, ChemoTech brings updates on its long-term clinical targets and ongoing projects.

 

Clinical strategy

Apart from continued validation of the beneficial effects in superficial tumours and palliative care settings, the clinical development goals of TSE are focused on earlier and curative lines of cancer treatment in combination with other therapies, especially immunotherapy, including deep-seated tumours.

 

Clinical Trial Progress
 

1. University Hospital in Jodhpur India, non-sponsored trials:

 

• It was publicly announced on 29th November 2023 that treatments for the initial patients under the revised protocol will commence in Q1 or Q2 of 2024.
• Patient enrolment commenced on time according to the revised protocol with three patients included so far after the amendment.
• In the last protocol amendment, Arms B and C were included in the study. These study arms include patients with unresectable locoregional recurrence of H&N cancer eligible for radiotherapy (Arm B) OR chemotherapy/targeted therapy/ immunotherapy or a combination with medical treatment (Arm C).

It is pertinent to mention here that the first patient for Arm B under the revised protocol has been enrolled and undergone the first treatment. This is the first time ever that a patient has been considered for TSE therapy prior to other second-line treatments.  

• The ongoing clinical trial is expected to be completed in H1(the first half) of 2025.
• A protocol for breast cancer has been discussed and we are aiming for approval H1 2025. 
• Ongoing discussions regarding pilot studies for deep-seated tumours such as pancreatic cancer.
• For cases performed routinely, i.e., outside the clinical trial at AIIMS, a write-up for a case series publication has been completed and is with the journal for peer review. Expected to be online Q3 2024.
   

2.  Other Studies

• Pancreatic study protocol for TSE in combination with immunotherapy has been shared with King Faisal Hospital, Rwanda.
  Update - On hold and looking for collaborators for this clinical trial.
• Protocol for breast cancer clinical validation study has been shared with the investigator at Kakamega General Hospital, Kenya. Discussions are ongoing with the regulatory authorities to include TSE in the payment system in Kenya. 
  Update - due to a focused strategy on India for Human Care this project has been put on hold.
• Clinical Study Data from Malaysia has been received.
  Update – targeted to be published in Q4 2024.  

 

Clinical Achievements and Updates

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

​​​​Upcoming

1. After receiving MD-42 in India this year MD14 / MD15 (mandatory re-registration) is expected in H2 2024.
2. Treatment data from the Malaysian trial to be published as a case series report by the lead investigator
3. Registration of TSE in Australia targeted for Q4 2024
4. European re-certification of CE mark under the Medical Device Regulation MDR, latest by 2028

CMO Suhail Mufti will provide further details on the updates mentioned above in a pre-recorded presentation, which will be available from Monday July 15^th at 18.00 CET.

You can view the presentation on our YouTube channel:

https://www.youtube.com/@scandinavianchemotechabpub4074

A separate direct link will be posted before the presentation. 

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]

 

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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.