The trial has been designed to evaluate the efficacy of Modrenal in patients who have failed prior endocrine therapy with the new generation aromatase inhibitors. The study will be conducted in nine leading UK centers and will enroll up to an additional 54 patients.
The first patients have also been enrolled in a phase II trial, which evaluates the benefit of Modrenal for women with pre-menopausal advanced breast cancer, who have relapsed or are refractory to prior therapies.
“These new, multi-center studies are an important step in the commercial development of Modrenal, which has already demonstrated significant efficacy in patients whose prior treatments have failed,” commented Dr Christopher Wood, chairman and CEO of Bioenvision.
Initiation of the new clinical trial program follows the discovery of new mechanisms of action for Modrenal, which is now known to be effective in cases of acquired endocrine resistance.