Scandinavian ChemoTech AB (publ) provided 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. 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 first quarter or second quarter 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 first half of 2025. A protocol for breast cancer has been discussed and the company 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 third quarter 2024.

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 fourth quarter 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.