EMERYVILLE, Calif., Aug. 2 /PRNewswire-FirstCall/ -- Bionovo, Inc. (Nasdaq: BNVI) today announced results from studies in neurons of its drug candidate Menerba for the treatment of menopausal hot flashes. The study, published in the Public Library of Science (PLoS) One, describes a novel model for thermoregulatory control with neurons that are differentiated from stem cells, and express native estrogen receptors. Menerba, an estrogen receptor beta selective modulator, was shown to regulate calcium influx, which is related to temperature regulation.
"Menopausal hot flashes occur in approximately 80% of menopausal women. While estrogens are very effective in the treatment of menopausal hot flashes, they have been associated with many serious health risks, such as breast and uterine cancer. Recognizing this, we have been trying to develop safer ways of treating hot flashes and other menopausal symptoms. But to do that, we need to have reliable models for thermoregulatory control – something that we have not had previously. Our study showed that neurons derived from embryonic stem cells are a valuable screening model to identify new treatments for hot flash management because they reliably show a drug candidate's ability to act directly at the neural level. We also found that Menerba, an estrogen receptor beta selective drug candidate being developed by Bionovo, does indeed regulate the activity of the neurons, identifying this receptor subtype as an important target for new drugs for treating hot flashes," said Dr. Dale Leitman, from the Department of Nutritional Science and Toxicology, University of California, Berkeley, who is the Principal Investigator of the study.
"This is a novel and valuable model for investigating thermoregulation," said Isaac Cohen, Bionovo's Chairman and Chief Executive Officer. "In a Phase 2 clinical trial, Menerba, our selective estrogen receptor beta modulator, showed that it was effective in the treatment of hot flashes, but unlike estrogen, it did not adversely affect the uterus. This study provides an explanation on how Menerba is able to control hot flashes. With the clinical data already developed, and the data from Dr. Leitman's research, we are much more confident in Menerba as it enters pivotal Phase 3 trials."
The publication is entitled "Estrogen Receptor B-Selective Agonists Stimulate Calcium Oscillations in Human and Mouse Embryonic Stem Cell-Derived Neurons" and can be found on the PLoS One website and at http://www.bionovo.com/investors/publications.
About Menerba
Menerba is an oral, botanically-derived drug candidate designed for the safe, effective treatment of vasomotor symptoms (hot flashes) associated with menopause. Menerba is an estrogen receptor beta (ER-B) selective drug, developed as a safer alternative to the products currently on the market, which have been shown to increase the risk for breast and uterine cancers. Clinical tests conducted thus far, following the specific guidance of the FDA, have indicated that Menerba is effective and safe.
About Bionovo, Inc.
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.
SOURCE Bionovo, Inc.
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"Menopausal hot flashes occur in approximately 80% of menopausal women. While estrogens are very effective in the treatment of menopausal hot flashes, they have been associated with many serious health risks, such as breast and uterine cancer. Recognizing this, we have been trying to develop safer ways of treating hot flashes and other menopausal symptoms. But to do that, we need to have reliable models for thermoregulatory control – something that we have not had previously. Our study showed that neurons derived from embryonic stem cells are a valuable screening model to identify new treatments for hot flash management because they reliably show a drug candidate's ability to act directly at the neural level. We also found that Menerba, an estrogen receptor beta selective drug candidate being developed by Bionovo, does indeed regulate the activity of the neurons, identifying this receptor subtype as an important target for new drugs for treating hot flashes," said Dr. Dale Leitman, from the Department of Nutritional Science and Toxicology, University of California, Berkeley, who is the Principal Investigator of the study.
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"This is a novel and valuable model for investigating thermoregulation," said Isaac Cohen, Bionovo's Chairman and Chief Executive Officer. "In a Phase 2 clinical trial, Menerba, our selective estrogen receptor beta modulator, showed that it was effective in the treatment of hot flashes, but unlike estrogen, it did not adversely affect the uterus. This study provides an explanation on how Menerba is able to control hot flashes. With the clinical data already developed, and the data from Dr. Leitman's research, we are much more confident in Menerba as it enters pivotal Phase 3 trials."
The publication is entitled "Estrogen Receptor B-Selective Agonists Stimulate Calcium Oscillations in Human and Mouse Embryonic Stem Cell-Derived Neurons" and can be found on the PLoS One website and at http://www.bionovo.com/investors/publications.
About Menerba
Menerba is an oral, botanically-derived drug candidate designed for the safe, effective treatment of vasomotor symptoms (hot flashes) associated with menopause. Menerba is an estrogen receptor beta (ER-B) selective drug, developed as a safer alternative to the products currently on the market, which have been shown to increase the risk for breast and uterine cancers. Clinical tests conducted thus far, following the specific guidance of the FDA, have indicated that Menerba is effective and safe.
About Bionovo, Inc.
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.
SOURCE Bionovo, Inc.
