Cyclana Bio launches landmark endometriosis study, enrolling first 500 patients to build 3D disease models from human tissue.
Regulatory green light and recruitment underway for PEMP study
Cyclana Bio, a biotechnology company, has received regulatory approvals and recruited the first participants for a clinical observational study on endometriosis. The study, named PEMP (Predicting Endometriosis Mechanisms and Populations), is enrolling 500 patients.
The study has received approval from the Health Research Authority (HRA) and the Research Ethics Committee (REC). The first participants were recruited at Peterborough City Hospital, with recruitment also beginning at the Rosie Hospital in Cambridge.
Study objectives: building 3D models from patient samples
The PEMP study aims to increase understanding of endometriosis physiology. Cyclana Bio plans to use human data, as well as cells from biopsies and menstrual fluid donated by participants, to construct 3D in vitro models of the disease.
These models are intended to aid in understanding basic biological mechanisms and identifying potential drug targets.
The study also aims to develop tools for stratifying patients based on clinical need.
Methodology: comparing tissue dynamics and causal mechanisms
Researchers will compare tissue-level dynamics in individuals without endometriosis to those with the condition. The study will collect data to investigate whether endometriosis has a common causal mechanism or requires personalized treatment approaches. Cyclana Bio has previously reported involvement of the extracellular matrix (ECM) in the disease.
Conduct and personnel
The study is being conducted by Cambridge University Hospitals NHS Foundation Trust and North West Anglia NHS Foundation Trust.
- Chief Investigator: M. Saikat Banerjee at the Rosie Hospital.
- Principal Investigator at Peterborough: M. Lukasz Polanski.
- Investigator at Cambridge: Dr. Norman Shreeve.
Funding and future plans
The study is funded by Cyclana Bio's £5 million pre-seed funding round. The company plans to use future financing to recruit additional study sites and expand its methodology to other chronic inflammatory conditions.