Key Developments For Bionovo, Inc.
Bionovo, Inc. (BNVI.O) (Consolidated Issue listed on NASDAQ Capital Market)
Bionovo Inc. Announces Publication Of Data On Potential Increase In Breast Cancer Risk
Bionovo Inc. announced the publication of results from its study on the inhibitory effect of tamoxifen on estrogen receptor beta (ERb) gene regulation. The results of the study, which will be published in Molecular and Cellular Endocrinology, demonstrate that tamoxifen inhibits the beneficial effects of ERb in the prevention of breast cancer cell proliferation. Since the discovery of ERb, various studies have demonstrated that this receptor plays an important role in preventing breast cancer cell proliferation and tumor formation. These studies indicate that ERb is an important therapeutic target for drugs in development for breast cancer treatment and prevention. It has also been shown that approximately 40% of breast tumors express ERb, which suggests that this large subset of tumors could be inhibited by selective ERb drugs. This publication describes the effect of tamoxifen on hormone independent regulation of genes by ERb that are important in preventing the proliferation of breast cancer cells. The study shows that the pattern of gene expression by ligand independent regulation by ERb is inhibited by the administration of tamoxifen in estrogen dependent breast cancer cells. Moreover, this study shows that tamoxifen inhibits the recruitment of important coregulatory proteins to the receptor, which demonstrates that the effect observed is directly due to the interaction of tamoxifen with ERb.
Bionovo Inc. Announces Pricing of Securities Offering
Bionovo Inc. announced that it has entered into agreements with selected investors to sell up to 3,230,995 units at a price per unit of $6.20 for aggregate gross proceeds of up to $20.0 million. Each unit consists of ten shares of common stock and ten warrants. Each warrant entitles its holder to purchase one share of Bionovo common stock at an exercise price of $0.85. The warrants may be exercised at any time after six months from the date of the closing and will expire after five years. The offering is expected to close on or about October 7, 2009. Bionovo expects to use the net proceeds from this offering to advance its lead drug candidate for postmenopausal vasomotor symptoms, Menerba, into Phase 3 clinical trials, and the remaining net proceeds, if any, for general corporate purposes. Dawson James Securities acted as the exclusive placement agent for the offering.
Bionovo Inc. To Present On Female Specific Drugs For Obesity
Bionovo Inc. announced that it will present the results of a study on the effects of two plant-derived, tissue-selective estrogen receptor alpha (ERa) modulators (TSERaM) for obesity. In this study, ovariectomized female mice, mimicking menopause, were placed on a high fat diet for one month prior to initiation of treatment. While the untreated mice continued to gain weight, the mice administered with estrogens or the plant-derived TSERaMs lost weight. While estrogens had positive effects on the body fat mass, they significantly increased the size of the mammary gland and uterus. In contrast, the same tissues in the plant-derived TSERaM-treated mice closely resembled those of the untreated mice. These findings suggest that the development of botanically-derived, tissue-selective ERa modulators could result in a safer alternative for the treatment of menopausal weight gain and the prevention of metabolic syndrome and its associated risks.
Bionovo Inc. To Present Positive ResultsFfrom Phase 2 Trial of Menerba For Vasomotor Symptoms
Bionovo Inc. announced that it will be presenting the positive results from the phase II clinical trial of their lead drug candidate for postmenopausal symptoms, Menerba, to the international community at the 8th Annual European Society for Gynecology (EGS) in Rome, Italy. The phase II clinical trial was designed to evaluate the safety and efficacy of two doses of Menerba versus placebo. The trial was a randomized, double-blinded, placebo-controlled study that enrolled 217 healthy postmenopausal women reporting moderate to severe hot flashes. Highlights from the trial include: After 12 weeks of treatment, there was a statistically significant decrease in frequency of all hot flashes in the higher dose of Menerba (p=0.04), there was a clear dose response trend in multiple efficacy analyses,Menerba reduced the number of times women were awakened from sleep due to hot flashes. The median percent reduction in night sweats in the higher dose of Menerba was 67%, statistically superior to placebo (p=0.05), compliance and study retention was excellent: 98% of participants completed the trial, with 91% of participants taking at least 75% of the assigned study medication, only statistically significant adverse event was transient loose stools. During the trial, there was no difference in the number of uterine bleeding episodes between the treatment groups and placebo and no cases of endometrial hyperplasia or uterine cancer, further demonstrating Menerba's excellent safety profile.
Bionovo Inc. Presents Positive Results From Phase 1B Trial Of Bezielle For Metastatic Breast Cancer
Bionovo Inc. announced the positive results from the Phase 1B clinical trial of Bezielle (formerly BZL101), their lead drug candidate for advanced breast cancer. In the trial, Bezielle showed an excellent safety and tolerability profile, and also showed promising indications of efficacy in a difficult-to-treat population. The Phase 1B clinical trial was conducted at eight US clinical sites under the directorship of Dr. Charles Shapiro, Professor of Medicine and Director of Breast Oncology at Ohio State University. The primary objective of the study was to identify the maximum tolerated dose of Bezielle and to determine the safety, feasibility and preliminary efficacy of the Company's novel, oral, anticancer therapy. A total of twenty-seven women with metastatic breast cancer were enrolled to the Phase 1B trial. To date, 48 women with advanced breast cancer have been successfully treated with Bezielle in two early clinical trials. In a previous Phase 1A study, Bezielle demonstrated very limited toxicity with a favorable tolerability profile and encouraging clinical activity among a cohort of patients with metastatic breast cancer who had been heavily pretreated with anticancer therapies. Results from this second Phase 1B study provide further support that Bezielle is safe and well-tolerated, with early signs of clinical efficacy.
