New studies launched with Modrenal.

2004 JAN 1 - (NewsRx.com & NewsRx.net) -- Bioenvision, Inc., (BIV) announced its intention to conduct new studies in the U.K. in premenopausal, preoperative, and postmenopausal women for its lead breast cancer treatment Modrenal (trilostane).

The announcement was made at the prestigious International Breast Cancer Symposium in San Antonio, Texas, where key consultations are taking place with leading breast cancer specialists to finalize protocols for the new studies.

The aim of the postmenopausal phase IV study is to confirm Modrenal's proven clinical benefit in patients who have relapsed after third generation aromatase inhibitor therapy. Sixty patients will be enrolled into the study, completion of which is planned for fourth quarter 2004.

The phase II study of pre-menopausal breast cancer patients will evaluate Modrenal's efficacy following relapse to first line endocrine therapy. Fifty-five patients will be enrolled in this study, which is expected to be completed by the end of 2004.

The research, planned to commence in the first quarter of 2004, will build upon the existing large database and further evaluate the efficacy of Modrenal in women with breast cancer who may fall outside the current U.K. indication for the treatment of advanced, postmenopausal breast cancer following relapse on prior endocrine therapy.

Leading U.K. cancer specialist, professor Robert Leonard of The South Wales Cancer Institute, Swansea, present in San Antonio commented, "Modrenal has shown impressive clinical benefit rates in patients with previously treated breast cancers. The new studies will help to ensure that the full potential of Modrenal, as part of a fully integrated treatment program, can be determined for wider patient groups such as premenopausal women and those who have been diagnosed with breast cancer and are awaiting surgery."

Modrenal is ...