Bionovo Inc. has begun enrolment for its single ascending dose pharmacokinetics clinical trial to further evaluate the company's lead drug candidate, MF101, designed to treat the symptoms of menopause. The clinical trial will take place at the University of Colorado at Denver and Health Sciences Centre, with Dr Thomas Henthorn as lead investigator.
Dr Henthorn, Prof. and chair of the Department of Anaesthesiology at the UCDHSC, is on the editorial board of the journal clinical pharmacology and Therapeutics and reviews manuscripts for several anaesthesiology and pharmacology journals. He has served on research review committees for the National Institutes of Health (NIH) and the Department of Veterans Affairs Merit Review. In addition, Dr Henthorn currently serves on the American Society of Anaesthesiologists Committee on Drug Disposition and chairs the committee on Biochemistry and Aesthetic Action.
A total of 184 post-menopausal women out of 217 women randomised to the double-blind, placebo-controlled phase 2 study, started in October 2006, have completed their 12-week, off-study medication visit. To date, there have been no cases of uterine hyperplasic or uterine cancer during the trial.
Moreover, adherence to the study medication in the phase 2 trial has been high and the drop out rate has been less than 10 per cent.
"We are encouraged by our preliminary phase 2 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."
Bionovo is a drug development company focusing on the discovery of novel pharmaceutical agents for cancer and women's health. The company has two drugs in clinical testing. MF101 is in phase 2 for quality of life conditions associated with menopause and BZL101 is in phase 1/2 for the treatment of advanced breast cancer. The company has an additional pipeline of drugs in development for breast cancer, pancreatic cancer and other menopausal symptoms with a total of 5 drug candidates expected to be in clinical trials by the end of 2007.