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Product profile
Cx501 is a cell therapy medicinal product for the treatment of epidermolysis bullosa (EB). EB is a hereditary disease that affects skin. Patients with EB experience blister formation and skin breakage upon the slightest friction, often while carrying out activities of daily living. There is currently no satisfactory treatment for EB. Patients are at a high risk of dying at an early age due to development of squamous cell carcinoma, although the incidence of death due to renal failure is also high.
Cx501 is a novel medicinal product consisting of a chimeric skin equivalent (using components from both patients themselves and donors) comprising two layers (dermal and epidermal layers) as follows:
- Artificial epidermis Autologous human keratinocytes.
- Artificial dermis: a three-dimensional matrix consisting of a fibrin-rich substrate obtained from pure blood plasma of an allogeneic source to which healthy allogeneic human fibroblasts are incorporated.
Cx501 has been designated by the European Medicines Evaluation Agency as an orphan drug and has been evaluated in a Phase II, multicenter clinical study.
Advantages of Cx501
Cx501 is a unique product; well differentiated from all other currently available or technologically equivalent skin equivalents.
Advantages of the cell component
The combination of allogeneic cells and cells from patients themselves (healthy fibroblasts and keratinocytes respectively) is a completely new approach that offers a real and lasting therapeutic option, as it potentially allows for the adequate functions of a healthy skin, preventing rejection of the new graft. Healthy fibroblasts persist after implantation and contribute to skin healing.
Advantages of the three-dimensional matrix
The human plasma reconstructs the physiological conditions of the wound repair process in the body. The matrix promotes an improved growth of fibroblasts and keratinocytes, thus allowing for obtaining large skin surfaces from a very small biopsy.
Based on the capacity of ASCs to inhibit immune cell activation, proliferation, and function through selective induction of regulatory T cells (Tregs), Cellerix started development of an immunotherapy platform for large scale production of regulatory T cells.
Cx911 (Tregs generated in the presence of ASCs) is the first product within this program and is currently in the preclinical phase.
Development of this immunotherapy platform will allow Cellerix to reach wider markets within the area of tailor-made medicine for the treatment of autoimmune diseases.