Bionovo, Inc. has begun enrollment for its single ascending dose pharmacokinetics clinical trial to further evaluate the company's 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 Center, with Dr. Thomas Henthorn as lead investigator.
Dr. Henthorn, Professor and Chair of the Department of Anesthesiology at the UCDHSC, is on the editorial board of the journal Clinical Pharmacology and Therapeutics and reviews manuscripts for several anesthesiology 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 Anesthesiologists Committee on Drug Disposition and Chairs the Committee on Biochemistry and Anesthetic Action.
A total of 184 post-menopausal women out of 217 women randomized 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 hyperplasia 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%. The company expects to have full results from the Phase 2 trial in the second quarter of 2007.
"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."