MHRA: "Intercytex' ICX-RHY a tissue rather than drug product"

UK-based cell therapy specialist Intercytex says that the domestic drug and device licensing authority, the Medicines and Healthcare products Regulatory Agency, has confirmed that ICX-RHY, its product for facial rejuvenation, will fall under the proposed definition of a tissue engineered agent once the draft European Commission Regulation on advanced therapy medicinal products becomes effective.

The MHRA also confirmed that, pending implementation of this Regulation, the supply or sale of ICX-RHY would not be subject to the licensing and other provisions of The Medicines for Human Use Regulations 1994 or the Medicines Act 1968. Accordingly, Intercytex plans to make ICX-RHY available in the UK market when convincing safety and efficacy data are available.

The firm is currently conducting a Phase I safety trial of ICX-RHY and is planning to start a Phase II study in the middle of the year. The product has been conceived as a cell therapy approach to the long-term rejuvenation of rhytids (wrinkles) and other skin blemishes such as scarring. It comprises a suspension of allogeneic human dermal fibroblasts which are injected into the dermis of the skin to provide a source of young collagen-secreting cells, the firm noted.