Bionovo Announces the Publication of its Tissue Selective Estrogen Receptor Modulators for Postmenopausal Obesity

EMERYVILLE, Calif., Dec. 8, 2011  /PRNewswire/ -- Bionovo, Inc. (NASDAQ: BNVI), a pharmaceutical company focused on the discovery and development of safe and effective treatments for women's health and cancer, today announced the publication of a study on the effects of two botanically-derived, tissue selective estrogen receptor modulators for the treatment of postmenopausal obesity in the Journal of the Public Library of Science One.

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On average, women transitioning through menopause experience a 10-15 pound weight gain with a redistribution of fat to the abdomen. Menopausal changes of body weight and increased abdominal fat increases the risk of cardiovascular disease, Type 2 diabetes and metabolic syndrome. The study describes a new class of botanically-derived, tissue selective estrogen receptor modulators in adipose tissue which cause weight loss in mice without the unwanted proliferative effects in breast and uterine tissue that are associated with cancer.

"Estrogens used in menopausal hormone therapy have been shown to reduce weight and fat redistribution as well as Type 2 diabetes, but unfortunately they also result in increased risk for breast and uterine cancer, among other risks," said Dale Leitman, M.D., Ph.D. from the University of California, Berkeley and the principal investigator of the study. "Unfortunately, the estrogens currently used in menopausal hormone therapy are not clinically useful for the treatment of obesity and diabetes because they activate estrogen receptors in all tissues. While activating these receptors produces beneficial effects in some tissues, such as fat it leads to serious side-effects in other tissues that can increase the risk of cancer. We are taking a unique approach to discovering new, safer tissue estrogenic drugs by identifying estrogens that act in fat tissue, but not in breast and uterine tissue, thereby, resulting in reducing obesity and diabetes without increasing the cancer risk seen with currently available estrogens." 

In this study, ovariectomized female mice, mimicking menopause, were placed on a high fat diet for two months prior to initiation of treatment with the two plant derived drugs. While the untreated mice continued to gain weight, the mice administered with estrogens or the botanically-derived tissue selective estrogen receptor modulators lost weight. While estrogens that are currently used in menopausal hormone therapy regimens had favorable effects on the body fat mass, they significantly stimulated proliferation of cells in the mammary gland and uterus. In contrast, the botanically-derived tissue selective estrogen receptor modulators did not adversely affect the breast or uterus. These findings suggest that the development of botanically-derived, tissue selective estrogen receptor modulators result in safer alternatives for the treatment of menopausal weight gain and the prevention of obesity, Type 2 diabetes and metabolic syndrome.

"Our scientific discoveries continue to show that Bionovo has a robust pipeline of drugs for the treatment of women's health for multiple important clinical indications that are safer than currently available therapies and in large demand by physicians and patients alike. There are 40 million women transitioning through menopause and a selective therapy that prevents or reverses weight gain through menopause would have enormous commercial potential," said Isaac Cohen, Chairman and CEO of Bionovo. "Metabolic syndrome can affect as many as 30% of postmenopausal women and being overweight and obese leads to an increase in morbidity and mortality. We believe that the tissue selective estrogen receptor modulators represent an exciting new class of drugs that have the potential to protect postmenopausal women from the many health risks associated with weight gain without increasing the risks of breast and endometrial cancer like the current estrogens used in hormone therapy."

About Bionovo, Inc.

Bionovo, Inc. 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.

SOURCE Bionovo, Inc.

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