Bionovo's Drug Candidate Shows In Vivo Safety and Efficacy in the Treatment of Vaginal Atrophy- Results Presented at Endocrine Society's 90th Annual Meeting -
SAN FRANCISCO and EMERYVILLE, Calif., June 16, 2008 /PRNewswire-FirstCall/ -- Bionovo Inc. today announced results from animal studies of its drug candidate, VG101. The data were presented at the Endocrine Society's 90th Annual Meeting in San Francisco, and showed that in animal models, VG101, an estrogen receptor beta selective modulator, is safe and effective for the treatment of vaginal atrophy or "vaginal dryness."
"Vaginal dryness occurs in over 50% of menopausal women, resulting in long lasting pain and discomfort as well as an increased susceptibility to infections," said Dr. Dale Leitman, from the Department of Obstetrics, Gynecology and Reproductive Sciences at the . "We compared the selective estrogen, VG101, to the estrogen currently prescribed. VG101 restored the vagina to normal appearing tissue. We also found that estrogen caused increased uterine growth and caused abnormal cells, whereas VG101 did not."
The study was conducted by investigators at The Center for Reproductive Sciences in the Department of Obstetrics, Gynecology and Reproductive Sciences at the in collaboration with scientists at Bionovo.
"The safety of estrogens for the treatment of vaginal dryness has not been well elucidated. Local application of existing estrogen products results in significant systemic absorption and long term use may be risky for women," said Isaac Cohen, Bionovo's chairman and chief executive officer. "Our selective estrogen receptor beta modulator, VG101, was effective in restoring the vaginal canal, but more importantly, unlike estrogen, it did not cause any uterine growth. This suggests, that unlike estrogens, it will not increase the risk of uterine cancer. VG101 will enter human clinical testing later this year. We believe that demonstrated efficacy coupled with improved safety will be greatly welcomed by women."
Dr. Cohen continued, "VG101 is another showcase component of Bionovo's robust and important pipeline under development for women's health."
VG101 is a topical vaginal preparation designed for the treatment of menopausal vaginal atrophy. VG101 is manufactured from substances derived from three botanical species. VG101 activates transcriptional gene regulation only via the estrogen receptor beta. There are two estrogen receptors subtypes, the alpha and beta. When estrogen receptor alpha is stimulated it results in cell proliferation and tumor formation, whereas when the beta form is stimulated it results in the opposite effect, inhibition of growth and prevention of tumor formation. There are currently approximately 40 million women of menopausal age. Vaginal atrophy and dryness, is experienced by 55% of menopausal women. While 75% of middle-aged women report that sex is moderately to extremely important, 41% experience painful intercourse.
Bionovo is a pharmaceutical company focused on the discovery and development of safe and effective treatments for women's health and cancer, which are 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.
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Posted: June 2008