Date: 2011-03-15
Type of information: Initiation of preclinical development
phase: 2
Announcement: initiation
Company: King’s College London (UK) Intercytex (UK) DEBRA (UK)
Product: ICX-RHY
Action
mechanism: ICX-RHYis a suspension of human dermal fibroblasts (HDFs, which are naturally derived skin cells) in cell storage medium, for injection into the skin. The newly introduced HDFs are thought to repair the extracellular matrixto improve skin structure and function.
ICX-RHYis designated as one of the first Advanced Therapy Medicinal Products (ATMP) by the European Medical Agency and has already been used in clinical trials and compassionate use programmes in over 100 patients in a variety of indications.
Disease: Recessive Dystrophic Epidermolysis Bullosa (RDEB)
Therapeutic area: Rare diseases - Genetic diseases - Dermatological diseases
Country: UK
Trial
details: The placebo controlled trial will involve 20 RDEB patients. It will be led by Professor John McGrath, Professor of Molecular Dermatology at King’s College London and Honorary Consultant Dermatologist at Guy’s and St Thomas’ NHS Foundation Trust, London, who will administer a single series of ICX-RHYinjections or placebo around the margins of several selected skin erosions. The injections will take place at the Clinical Research Facilities at Guy’s Hospital. Patients will then be assessed initially over a three month period to measure end points including time to wound closure, wound recurrence and erosion pain. The trial, which is scheduled for completion early in the autumn,is funded jointly by Intercytex, The Technology Strategy Board and DEBRA.
Latest
news: King’s College London; the regenerative medicine company Intercytex; and the patient charity DEBRA, have announced the start of a Phase II trial with the Intercytex therapy ICX-RHY to treat skin erosions in patients suffering from the severe genetic skin disorder Recessive Dystrophic Epidermolysis Bullosa (RDEB). In such patients the skin blisters at the slightest knock or rub, causing painful, open wounds which result in scarring and fusion of fingers.
