Since it was discovered that the risks of hormone therapy outweighed the benefits, scientists have been searching for a safe, natural way to alleviate the symptoms of menopause.
Participants are currently being recruited for a follow-up clinical trial of a treatment known as MF101 developed by Bionovo, Inc. In its initial clinical trial, MF101 provided women in the study with preliminary evidence of relief from such symptoms as hot flashes and night sweats, without the risks associated with hormone therapy.
The treatment being tested clinically targets only one of the two known estrogen receptors-the estrogen receptor beta. Laboratory data has shown that MF101 does not cause the proliferation of breast or uterine cancer cells the way hormone therapy can, making the drug a safer alternative to currently available hormone therapies.
In 2002, the Women’s Health Initiative (WHI) Estrogen Plus Progestin Trial, with over 16,000 women participants, was stopped early when it was found that the standard dose of combination hormone therapy increased the risk of breast cancer, stroke, heart attacks, blood clots and dementia.
“Given the void that exists for a safe and effective treatment for menopausal symptoms, our aim is to discover and develop novel drugs such as MF101 that can abate many of the symptoms that have historically been treated with hormones,” said Dr. Mary Tagliaferri. Tagliaferri is co-author of “The New Menopause Book: The Experts Help You Make Informed Decisions on HRT, Natural Hormone Therapy, Herbal Therapies, Traditional Chinese Medicine And More” (Avery, 2006) and Chief Medical Officer of Bionovo, which is developing the drug.
The clinical trials will take place under the directorship of renowned researcher Dr. Deborah Grady at four leading academic medical centers.
Bionovo expects this Phase 2 trial to be completed by the second quarter of 2007.
“If this new drug proves to be effective, we will be providing health care practitioners with a treatment they can comfortably recommend to women experiencing menopause,” said Dr. Tagliaferri.