Bionovo's MF101 Shows Statistically Significant Improvement in Sleep Disturbance from Hot Flashes
EMERYVILLE, Calif., September 15, 2008 /PRNewswire-FirstCall/ -- Bionovo, Inc. today announced that its lead drug candidate, MF101, for menopausal hot flashes, showed improved sleep quality for women in a Phase 2 study completed earlier this year. The Company previously announced that the study showed positive results in the Phase 2 trial for the primary endpoint of reducing the number of hot flashes when compared to placebo. Additional analyses from the Phase 2 trial now show that 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 the placebo (p=0.05). Women randomized to the lower dose of MF101 also had a greater reduction of night time awakenings due to hot flashes compared to placebo (58% reduction versus 44% reduction with placebo).
The trial was conducted under the directorship of Dr. Deborah Grady at the and recruitment took place at six medical centers in the United States: , , , , and the San Diego Medical Center for Clinical Research. Two hundred and seventeen women were enrolled in the company's multicenter, double-blind, placebo-controlled, randomized Phase 2 trial. Postmenopausal women with 50 or more moderate to severe hot flashes per week were randomized to one of three treatment groups receiving one of two doses of MF101 or placebo for twelve weeks.
Bionovo's primary objectives in the Phase 2 clinical trial were to assess the safety, tolerability and efficacy of two doses of MF101 to reduce the frequency and severity of hot flashes. Both doses of MF101 were more effective than placebo at reducing the frequency and severity of hot flashes from the start of the trial until the end of the treatment period 12 weeks later.
There was a clear dose response demonstrating that the higher dose of MF101 was more effective at reducing night time awakenings from hot flashes compared to the lower dose and the lower dose was more effective than placebo. These data are also consistent with the dose response trend previously reported where the higher dose of MF101 was more effective at reducing both the frequency and severity of hot flashes than the lower dose and both doses were more effective than placebo.
"These additional positive findings showing that MF101 can improve sleep quality in menopausal women are extremely exciting to the 40 million women who suffer from hot flashes and night sweats," said Mary Tagliaferri, M.D., President and Chief Medical Officer of Bionovo. "As we gear up to start recruitment for our Phase 3 clinical trial of MF101 for the treatment of menopausal hot flashes, these additional beneficial results will help with the swift recruitment of 640 postmenopausal women in this pivotal trial."
"Proving that MF101 significantly helps with menopausal sleep related symptoms further illustrates the potential of our lead drug," said Isaac Cohen, Chairman and CEO of Bionovo. "So far, MF101 has shown efficacy for the treatment of hot flashes and night sweats and our drug has an unmatched safety profile when compared to its competition. With the Phase 3 pivotal trial shortly underway, Bionovo is positioned to be a major player in the second largest indication in Women's Health after contraception, a multibillion dollar opportunity, with no competition with an equivalent offering anywhere in sight."
MF101 is an estrogen receptor (ER) beta selective drug developed as an alternative to postmenopausal hormone products currently on the market, which are both ER beta and ER alpha agonists that have been shown to increase the risk for breast and uterine cancers. It has been shown that the increased risk of breast and uterine cancers is associated with ER alpha activation and that ER beta blocks the growth promoting effects on breast cancer cells. Bionovo recognized the opportunity to commercialize a product that would be equally effective, with an improved safety profile compared to traditional hormone therapy. The clinical trial results have been evaluated by an independent Data and Safety Monitoring Board and the drug candidate has passed through a standard two-phase examination for safety.
Bionovo is a pharmaceutical company focused on the discovery and development of safe and effective treatments for women's health and cancer, markets with significant unmet needs and billions in potential annual revenue. The company applies its expertise in the biology of menopause and cancer to design new drugs derived from botanical sources which have novel mechanisms of action. Based on the results of early and mid-stage clinical trials, Bionovo believes they have discovered new classes of drug candidates within their rich pipeline with the potential to be leaders in their markets. Bionovo is headquartered in Emeryville, California and is traded on the NASDAQ Capital Market under the symbol, "BNVI". For more information about Bionovo and its programs, visit http://www.bionovo.com.
Forward Looking Statements
This release contains certain forward-looking statements relating to the business of Bionovo, Inc. that can be identified by the use of forward-looking terminology such as "believes," "expects," or similar expressions. Such forward-looking statements involve known and unknown risks and uncertainties, including uncertainties relating to product development, efficacy and safety, regulatory actions or delays, the ability to obtain or maintain patent or other proprietary intellectual property protection, market acceptance, physician acceptance, third party reimbursement, future capital requirements, competition in general and other factors that may cause actual results to be materially different from those described herein as anticipated, believed, estimated or expected. Certain of these risks and uncertainties are or will be described in greater detail in our filings with the Securities and Exchange Commission, which are available at http://www.sec.gov. Bionovo, Inc. is under no obligation (and expressly disclaims any such obligation) to update or alter its forward-looking statements whether as a result of new information, future events or otherwise.
Web site: http://www.bionovo.com/
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Posted: September 2008