Dec 7, 2022
MediSieve Announces Positive Final Results from Phase 1 Clinical Trial
Magnetic Blood Filtration Platform shown to be safe and well tolerated, with no serious adverse events.
LONDON – December 07, 2022 – MediSieve, a privately held BioTech company developing the Magnetic Blood Filtration Platform, today announces positive final results from a Phase I clinical trial. The study enrolled 11 adults, of which 8 completed the study. The main inclusion criteria were healthy adults, 1:1 females to males ratio and aged 18-50 years.
The study met all primary and secondary endpoints, with all results indicating that the System used in the trial is safe and well tolerated. No serious adverse events were reported, and no difference was observed between genders.
Professor Peter Pickkers, Professor of Intensive Care Medicine at the Radboud University Medical Center in Nijmegen, the Netherlands, and Principal Investigator of this study said: “The results of this study are very encouraging. This is the first step for the MediSieve Magnetic Blood Filtration Platform that has the potential to benefit a wide range of patients. The ability to selectively deplete IL-6 from patients, for example, would provide a new treatment modality for the many ICU patients with diseases related to hyperinflammation. We are excited to be contributing to the development and validation of MediSieve’s technology.”
Dr Cristina Blanco-Andujar, CTO at MediSieve, said: “We are delighted with the results obtained in the phase 1 study, which looked at the safety of the Delivery Platform. No significant changes on the clinical chemistry or blood counts were observed throughout the study, including no significant change in platelet counts, which is commonly observed during extracorporeal treatments. The study has demonstrated that the treatment is well-tolerated and safe in healthy volunteers. This is the first step towards opening the horizon of possibilities of MediSieve’s technology with the introduction of our targeted Therapeutic Magnetic Beads.”
The primary objective of this trial was to evaluate the safety and tolerability of the Delivery Platform, focusing on the incidence of adverse events. Magnetic Beads will be included in the next study. A paper describing the trial and its full results is in preparation.
The Magnetic Beads can be designed to bind specifically to various different agents in blood, enabling the Magnetic Blood Filtration Platform to be adapted to different indications thereby unlocking new clinical and commercial opportunities for MediSieve. MediSieve is actively exploring opportunities in Acute Hyperinflammation, Gene Therapies, Oncology and Severe Malaria. Uniquely for Severe Malaria, the Delivery Platform can deplete Malaria infected erythrocytes without the need for any Magnetic Beads.
Dr George Frodsham, Founder and CEO at MediSieve, said: “This trial is the first time our products have been used in a clinical environment, and we are thrilled that the results have been so positive. The Delivery System is the key product that underpins our platform, and this data enables us to push towards the full potential of the technology. The next step for us is to perform clinical studies with our Magnetic Bead products, which have already undergone significant preclinical validation. We have three Bead assets under development, each solving a unique clinical problem, so we are very excited about the future.”
About Magnetic Blood Filtration
MediSieve's Magnetic Blood Filtration Platform is intended to enable the rapid and specific depletion of specific agents from the bloodstream of patients. The extracorporeal therapy uses therapeutic Magnetic Beads that are designed to bind specifically to the clinical target. The Beads are introduced into the extracorporeal circuit during the therapy, mixing with the patient’s blood and binding to the clinical targets. The Delivery Platform captures all the Magnetic Beads and bound targets, preventing their return to the patient.
MediSieve is a London-based BioTech start-up that has developed Magnetic Blood Filtration, a revolutionary platform therapy that enables the physical removal of specific substances from the bloodstream of patients. It can be used (1) as a direct treatment, (2) to increase the safety and efficacy of other therapies, or (3) to enable personalised medicine. The company is a spin-off from University College London and is developing its products at the White City Innovation District in West London. MediSieve is actively seeking investment and partnerships.
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