A total of 184 post-menopausal women out of 217 women randomized to the phase II study, started in October 2006, have completed their 12-week, off-study medication visit.
To date, there have been no cases of uterine hyperplasia or uterine cancer during the trial. Moreover, adherence to the study medication in the phase II trial has been high and the drop out rate has been less than 10%. The company expects to have full results from the phase II trial in the second quarter of 2007.
“We are encouraged by our preliminary phase II clinical data suggesting that MF101 continues to demonstrate a safer toxicity profile than the currently available hormone therapies,” stated Dr Mary Tagliaferri, chief medical officer of Bionovo.
“There is a large market need for safer and effective drugs to treat menopausal symptoms and MF101 development is proceeding in order to help fill this void.”