Bionovo, Inc. (OTCQB: BNVI), a pharmaceutical company focused on the discovery and development of safe and effective treatments for women's health and cancer, announced today that the Company's independent Data Safety Monitoring Board (DSMB) recommended that the Phase 3 trial of Menerba (MF101) could continue as designed after an initial review of its clinical safety and tolerability data. Menerba is Bionovo's oral botanical drug candidate designed for the safe and effective treatment of vasomotor symptoms (hot flashes) associated with menopause.
The DSMB evaluated unblinded safety and dose tolerability data after 66 participants were randomized and on study medication for at least 30 days. After an independent review of the data, the DSMB issued their positive recommendation to continue the trial as originally designed and no concerning safety signals were identified.
"I am very encouraged by the positive recommendation from our independent DSMB. This assurance that Menerba™ continues to be a safe, well-tolerated, non-estrogen alternative therapy for the treatment of menopausal hot flashes is consistent with the promising results of our early clinical trial data and extensive pre-clinical toxicity studies. We are very eager to continue to develop a safe and effective treatment for post-menopausal hot flashes, a drug that can be the leading seller in the well established multibillion dollar market," said Mary Tagliaferri, M.D., Bionovo's President and Chief Medical Officer.
The MF101-004 Phase 3 pivotal study dosed its first patient on November 16, 2011. To date, a total of 280 postmenopausal women have been randomized to the trial. Recruitment to the Phase 3 trial was voluntarily halted on March 9, 2012 as Bionovo does not have adequate funding to further advance the registration trial. Bionovo will need to secure additional financing to complete either a smaller Phase 2B trial with the current cohort of 280 randomized participants or to complete the planned Phase 3 study.
The purpose of the study is to evaluate the safety and efficacy of two doses of Menerba™ (MF101) among a cohort of postmenopausal women for the treatment of menopausal hot flashes.
Participants are randomized to Menerba™ 5g/day, Menerba™ 10g/day or placebo and treated for 12 weeks. Efficacy will be measured by the reduction of moderate to severe hot flashes from baseline to 12 weeks of treatment Dr. Wulf Utian, Executive Director Emeritus and Honorary Founding President of the North America Menopause Society and Professor Emeritus at Case Western Reserve University is serving as the Principal Investigator for this study.
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