BTR-NTA: Non-confidential Summaries of Therapies Reviewed

 

Review Meeting 1 – November 2023

London, United Kingdom

GRACE – Glioma Resection Advanced Cavity Electric Field Therapy.

  • QV Bioelectronics
  • GRACE is an implanted device that delivers electric field therapy directly to tumour resection margins. The QV Bioelectronics team applied to the BTR-NTA programme to seek feedback on their preclinical strategy and clinical trial design. The BTR-NTA Committee provided feedback on preclinical safety and efficacy next steps and first in human trial design. The Committee also provided guidance in other areas of device development including, manufacturing, regulatory, funding, and patient and public involvement/engagement.

WISTERIAN – Window STudy of ExpeRimental Interventional Approaches to Neuro-oncology.

  • Dr Matthew Williams (Imperial College Healthcare NHS Trust), Dr Nelofer Syed (Imperial College London), and Dr Richard Perryman (Imperial College London)
  • The WISTERIAN study aims to explore the effects of giving ADI-PEG20 (acts via the depletion of arginine) in combination with radiotherapy prior to tumour resection surgery in newly diagnosed patients with radiologically diagnosed glioblastoma. Dr Williams, Dr Syed, and Dr Perryman applied to the BTR-NTA programme to seek feedback and guidance on their preclinical data and clinical trial design. The BTR-NTA Committee provided feedback in several areas, including safety considerations, biomarker selection, potential tools for collecting further preclinical data and clinical trial design.

MEMRISTIVE – Micro-electrochemical ablation and neuromodulation of recurring glioblastoma using hardware-AI accelerated brain implants.

  • Romeo Racz, DEng (Imperial College London) and Mr Kevin O’Neill (Imperial College Healthcare NHS Trust)
  • MEMRISTIVE is an implantable therapeutic neural interface designed to slow the progression of malignant brain tumours. Dr Racz and Mr O’Neil sought feedback from the BTR-NTA Committee on health economics, regulatory routes, market access and the clinical trials design. The BTR-NTA Committee provided guidance on the key preclinical next steps (including safety, feasibility, and efficacy) and other areas including, patient and public involvement/engagement, market access and regulatory pathways.