Phase III results with Scotia's EF27 have shown that the drug is effective in reducing a major side effect of breast cancer radiotherapy treatment, damage to the skin and sometimes the underlying tissues of the breast.
A total of 432 patients were entered into the study. After six weeks of radiotherapy, the peak time for skin reactions, EF27 treatment was associated with a 64% reduction in the number of women experiencing the most severe reactions compared to placebo (8.3% versus 3.0%). The average severity of damage at the scar site in all women was reduced by 22%.
On the basis of these results, Scotia plans to submit a product license application for EF27 to prevent skin reactions in patients undergoing anticancer radiotherapy in the UK in the first part of 1996. Data from the USA which show that EF27 does not prevent radiation damage to tumor cells, and may even increase the kill, will also be included in the dossier.
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