BACKGROUND ON THE TREATMENT OF HOT FLASHES AND NIGHT SWEATS ASSOCIATED WITH MENOPAUSE

40 million women in America are currently transitioning through menopause.

75% to 85% of them will experience vasomotor symptoms associated with menopause due to declining and fluctuating hormone levels.

Vasomotor symptoms associated with menopause, include hot flashes, night sweats, and associated insomnia.

Historically, postmenopausal hormone therapies containing estrogens were an effective treatment for vasomotor symptoms.

Data from the 2002 Women’s Health Initiative Estrogen Plus Progestin trial found that hormone therapy increases the risks of breast cancer, deep-vein thrombosis, pulmonary embolism, stroke, heart disease, and dementia.

Many physicians do not want to prescribe traditional HT for the treatment of vasomotor symptoms associated with menopause due to safety concerns.

A safe, effective treatment for vasomotor symptoms associated with menopause is needed.

ABOUT MF101

MF101 is an oral botanical drug designed for the treatment of vasomotor symptoms (hot flashes) associated with menopause. MF101 has a targeted mechanism of action which activates only the estrogen receptor beta pathway, which is associated with hot flashes. Unlike hormone therapy, MF101 does not activate the estrogen receptor alpha (ERα) pathway, known to be implicated in both breast and uterine cancer formation.

EARLY MF101 CLINICAL TRIAL RESULTS

Bionovo, Inc. has completed a series of randomized, double-blinded, placebo-controlled Phase 1 and Phase 2 clinical studies of MF101.

Phase 1 Results
In a Phase 1 clinical trial of MF101, conducted at the University of California, San Francisco, the drug was found to be safe, well tolerated and taken with high compliance. There was also statistically significant evidence of efficacy in the Phase 1 study.

Phase 2 Clinical Results
The Phase 2 clinical trial was designed to evaluate the safety and efficacy of 2 doses of MF101 versus placebo and was conducted under the direction of key opinion leader, Dr. Deborah Grady, at the University of California, San Francisco. The trial was a randomized, double-blinded, placebo-controlled study that enrolled 217 healthy postmenopausal women at 6 clinical sites in the U.S. who reported at least 50 moderate to severe hot flashes per week. Participants were randomized to receive MF101 5 g/day, MF101 10 g/day or identical placebo for 12 weeks.

The trial was completed by 98% of participants and 91% took at least 75% of assigned doses of study medication during the duration of the study. After 12 weeks of treatment, there was a statistically significant decrease in the frequency of all hot flashes in the higher dose of MF101 when compared to placebo. This trial provided evidence that treatment with MF101 reduced the frequency of hot flashes in healthy postmenopausal women and the drug was well tolerated.

The median reduction in the number of all hot flashes per week from baseline to 12 weeks of treatment was as follows: 68 to 41 in the placebo group, 63 to 32 in the MF101 low dose group and 67 to 31 in the MF101 high dose group. The difference in the median reduction in hot flashes per week after 12 weeks of treatment in the MF101 high dose group compared to placebo was statistically significant (p=0.04). Compared to placebo, women in the MF101 10 g/day group were 2.3-fold more likely to have at least a 50% reduction in all hot flushes at 12 weeks of treatment (OR 2.3, p=0.03), also, MF101 reduced the number of times women were woken up from sleep due to hot flashes, also known as “night awakenings” or “night sweats”. The median percent reduction in night time awakenings from hot flashes for women randomized to the higher dose of MF101 was 67%, and this reduction was statistically superior compared to placebo (p=0.05).

MF101 was very well tolerated and the only statistically significant side effect was loose stools (12% on MF101 versus 3% on placebo; p=0.03), which was most likely due to the presence of soluble fiber in MF101. For future studies, manufacturing improvements have been implemented to reduce the fiber content in order to minimize this one side effect.

Safety analyses showed no cases of endometrial hyperplasia or uterine cancer during the trial and there was no difference in the incidents of vaginal bleeding between the placebo group and the two cohorts treated with MF101. This has not been tested for safety in long term trials and long term affects are unknown.

Scientific Community and Physicians Respond to Study Results

• Data from MF101’s Phase 2 trial was presented and deemed the top-scoring abstract at the North American Menopause Society's annual meeting. The abstract, entitled, "A Novel Selective Estrogen Receptor-Beta Agonist for the Treatment of Menopausal Hot Flushes," was presented by the company's study trial’s principal investigator, Dr. Deborah Grady, a leading expert on menopause.

Phase 1 Safety Study Complete
An open label safety study enrolling 35 postmenopausal women to two doses of MF101 was completed in Q2 2011. The primary aim of this study was to assess the safety of 2 doses of MF101. The average age of participant was 53 and had at baseline an average of 73 hot flashes per week. There were no reported cases of serious adverse events, no abnormal findings on endometrial biopsies, no abnormal lab results, no changes to blood pressure, heart rate or weight and no concerning side effects from the treatments. Three US clinical sites participated in the Phase 1 study.

Phase 3 Study Now Enrolling
A Phase 3, multi-center, double-blinded, placebo-controlled trial of 1200 postmenopausal women with moderate to severe hot flashes is is now enrolling. The primary aim of this study is to determine the effect of two doses of MF101 on the frequency of hot flashes. Click here to find out more about the Phase 3 Clinical Trial for MF101.

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