I’m happy to notify that SIZOMUS (Safety of IxaZOmib targeting plasma cells in Multiple Sclerosis) is re-commencing after MHRA approval. This follows a pre-planned interim safety analysis.
MHRA stands for Medicines & Healthcare products Regulatory Agency and without their say so this trial would not have been able to proceed.
The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health and Social Care in the United Kingdom which is responsible for ensuring that medicines and medical devices work and are acceptably safe.
Why were the MHRA involved in SIZOMUS?
Ixazomib, the active agent in the study, although licensed for use in humans has not been tested in Multiple Sclerosis, nor it’s MOA (mode of action – cleaning the brain of plasma cells; the main source of antibodies in inflammatory disorders) studied in MS.
So of course, 5 participants (3 on active treatment; 2 on placebo) entered the study last year and took the drug for three months, and owing to lack of any significant side effects or serious adverse events the trial has now been given the go ahead to start full recruitment.
The running and safety of the clinical trial is overseen by the clinical trial committee. This committee is a star studded cast with many years of experience in MS and clinical trials:
- Chair: Dr Rachel Farrell, Consultant Neurologist, National Hospital for Neurology & Neurosurgery
- Second: Dr Wallace Brownlee, Consultant Neurologist, National Hospital for Neurology & Neurosurgery
- Observer: Professor Gavin Giovannoni, Professor of Neurology, Barts Health NHS Trust
- Lay representative: Mrs Catriona Whyte, MS Specialist Nurse, Essex Partnership University NHS Foundation Trust
- Statistician: Dr Jonathan Bestwick, Senior Lecturer, Wolfson Institute of Preventative Medicine, Queen Mary University of London
- Secretary: Miss Thamanna Begum, MS coordinator, Barts Health NHS Trust
- Governance: Mrs Sabiha Khan, Department of Research & Governanace, Queen Mary University of London
It has taken 4 years to get this clinical trial off the ground, some of the delay not surprisingly has been due to COVID-19. However, we are happy to have this now officially off the ground and excited to see the fruition of many years of concept work that is finally seeing the light of day.
MD (Mouse Doctor) has been integral to the scientific development of this project and I’m sure he is anxious to see the initial outcomes of the clinical trial!6.-PIS-v2.0-27Mar19-SIZOMUS-CLEAN
If you are interested in participation in the SIZOMUS study or would like to know more, please contact:
Dr. Mohammad Abouwafa (Wafa), Clinical Research Fellow for SIZOMUS; email@example.com
Disclaimer: Please note that the opinions expressed here are those of the author NDG and do not reflect the positions of the Barts and The London School of Medicine and Dentistry nor Barts Health NHS Trust or Queen Mary University of London.