Multi-cell therapies (MCTs) are derived from natural tissue extracts selected for the most active cells, removing components (such as red blood cells and platelets) that potentially reduce the cells’ therapeutic activity.
Our lead MCT, REX-001 is currently in development for the treatment of chronic limb-threatening ischemia (CLTI).
REX-001 is a composite multi-cell product that builds on the established biology of using cells from a patient’s own bone marrow to treat CLTI.
The product is an autologous bone-marrow-derived cell suspension enriched for white blood cells. It consists of a combination of progenitor cells and immune cells (lymphocytes, monocytes, granulocytes).
REX-001, is currently in a multi-site Phase 3 clinical trial for the treatment of CLTI (NCT03174522).
REX-001 is designed to address the complex disease processes (plaque deposition, inflammation, ischemia, vessel degeneration, ulcer formation) that lead to the clinical progression of CLTI.
REX-001 is being developed as a patient-specific cellular immunotherapy that delivers multiple immune and progenitor cells directly to the diseased vessels of the lower leg.
Using a proprietary manufacturing process, cells are selected and extracted from the patient’s own bone marrow. The cells are then optimized for cell composition, dose and administration procedure – a strategy shown to substantially improve clinical efficacy.
Local administration of REX-001 boosts the levels of beneficial immune-modulating cells (growth factors and cytokines), which are only present at very low levels in the peripheral blood and are further depleted in diseased patients.
The combination of multiple immune and progenitor cells acts to address the immune imbalance associated with CLTI, which manifests as atherosclerotic plaques and non-healing ulcers. The immune and progenitor cells heal ischemic ulcers by restoring the impaired immune balance to disrupt plaques, downregulate damaging inflammation, promote collateral recruitment, regenerate blood vessels, improve blood flow, reduce ischemia and restore disrupted tissue-healing processes.
Healing of ischemic ulcers and alleviation of ischemic rest pain leads to a substantial improvement in the patient’s quality of life.
IP and patent protection
The specific characteristics of REX-001 (cell composition, dose and administration procedure) have strong intellectual property protection through granted and pending patents, regulatory protection and unique know-how.