The three separate studies of Modrenal (trilostane) will investigate the efficacy of the treatment in three distinct settings: a phase IV trial in advanced, post-menopausal breast cancer; a phase II trial in pre-menopausal breast cancer; and a phase II trial utilizing Modrenal as a neo-adjuvant (pre-operative) treatment in post-menopausal breast cancer.
Instigation of this new clinical trial program follows the discovery of new mechanisms of action for Modrenal, which, according to Bioenvision, is now known to be effective in cases of acquired endocrine resistance.
“These multi-center studies are an important step in the development of Modrenal,” said Dr Christopher Wood, CEO and chairman of Bioenvision. “There is an enormous need for new drugs that offer alternative treatment options, especially for patients who have developed resistance to existing therapies.”
Modrenal is licensed and marketed in the UK to treat post-menopausal advanced breast cancer following relapse on initial hormone therapy and has demonstrated clinical benefit rates as high as 55%.