Engineered Skin Substitute (ESS)

Phase Preclinical Phase 1 Phase 2 Phase 3 Market
ESS Intractable Severe Burns
Preclinical Phase completed
Phase 1 Phase completed
Phase 2 Phase in progress
Phase 3 Phase not started
Market Phase not started

Engineered Skin Substitute (ESS) is a full thickness skin replacement product prepared from autologous (patient's own) tissue-engineered skin cells in development for the treatment of severe burns. It is a combination of cultured epithelium with a collagen-fibroblast implant that produces a skin substitute that contains both epidermal and dermal components. This model has been shown in preclinical studies to generate a functional skin barrier. Most importantly, self-to-self skin grafts for autologous skin tissue are less likely to be rejected by the immune system of the patient, unlike with porcine or cadaver grafts in which immune system rejection is a possibility. ESS has been used in an investigator initiated clinical setting in over 130 human subjects, primarily pediatric patients, for the treatment of severe burns up to 95% total body surface area. ESS received orphan drug designation from the U.S. Food and Drug Administration for the treatment of hospitalized patients with deep partial and full thickness burns requiring grafting.

Amarantus recently completed the acquisition of Cutanogen Corporation (Cutanogen) from Lonza Walkersville, Inc., a subsidiary of Lonza Group Ltd. Cutanogen has an exclusive worldwide license to intellectual property rights associated with Engineered Skin Substitute.

Amarantus expects to commence a Phase 2 study of ESS in the U.S. in the second quarter of 2016.