Cyclana Bio granted Health Research Authority approval and recruits first patients for clinical observational study in endometriosis
· News-MedicalCyclana Bio, a biotechnology company pioneering tissue-level approaches to women’s health, today announced it has received Health Research Authority (HRA) and Research Ethics Committee (REC) approval for its 500-patient clinical observational study, PEMP (Predicting Endometriosis Mechanisms and Populations). The first patients to take part in the study have been recruited at Peterborough City Hospital, with the Rosie Hospital, Cambridge recently also starting recruitment.
The PEMP study aims to improve the understanding of the disease physiology of endometriosis, a condition that affects 1 in 10 women, yet has limited available treatments due to a lack of available data and disease models. Cyclana Bio will use human data and cells collected from both biopsies and menstrual fluid donated by participants in the study to build physiologically relevant in vitro 3D models of the disease. These models will help uncover the basic biology and support the identification and prioritization of novel druggable targets for therapeutic development. The Company also aims to develop tools to better stratify patients based on clinical need, highlighting not just endometriosis but the differences in the disease.
To establish a better understanding of the mechanisms of the disease, Cyclana Bio will compare the tissue level dynamics in healthy women to those with endometriosis. Having previously confirmed the involvement of the extracellular matrix (ECM) in the manifestation of the disease, data from the study will also reveal whether endometriosis has a common underlying causal mechanism for which a single treatment can be developed, or whether a personalized medicine approach is needed.
Conducted by the Cambridge University Hospitals NHS Foundation Trust and the North West Anglia NHS Foundation Trust, the study is being led by Chief Investigator M. Saikat Banerjee at the Rosie Hospital alongside Peterborough City Hospital site Principle Investigator M. Lukasz Polanski and Cambridge site Investigator Dr. Norman Shreeve.
M. Saikat Banerjee, Chief Investigator, Rosie Hospital, CambridgeEndometriosis is sadly a common condition and yet we know so little, and as a result women’s suffering is further prolonged and treatments remain out of reach. With the use of the latest tools in molecular phenotyping and genomics, together with Cyclana Bio we are focused on correcting this problem through this observational study.”
The 500-patient study is being funded by Cyclana Bio’s £5 M pre-seed funding round, which closed last year. The Company will use future financings to recruit additional study sites and expand its whole tissue-based methodology to other underserved chronic inflammatory indications with similar tissue-level mechanisms.
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