Scotia Back On Track For Amelorad Approval

Scotia has reported new clinical trial data which could hasten theprogress of its radioprotectant Amelorad (EF27) through regulatory review in the UK. The Medicines Control Agency had asked for more evidence to show that the drug did not protect the tumor from the radiotherapy when used to reduce damage to normal skin.

Breast radiotherapy causes two types of reactions. The early reaction occurs around the six-week mark, and is characterized by radiation burns, around 10% of which are severe. Late-stage reactions peak at around one year and include telangiectasia, the growth of blood vessels in the skin, which occurs in about 40% of women.

The Phase III study followed 414 patients with breast cancer, half of whom received placebo while the other half received Amelorad, which comprises the n-6 fatty acid gamma-linolenic acid and the n-3 fatty acid eicosapentaenoic acid, for a period of 12 weeks. Results demonstrated a 15% overall reduction in breast skin damage within five to seven weeks after treatment initiation, and a 35% reduction after one year.