Bionovo Inc., a pharmaceutical company focused on the discovery and development of innovative treatments for women's health and cancer, announced that it had received the minutes from the US Food and Drug Administration's (FDA) Clinical Guidance meeting that took place on November 8, 2010. In that meeting, the FDA agreed with the company's proposed overall clinical development plan.
“We had a very positive meeting with the FDA to discuss the clinical programme for Menerba. The Agency agreed with our overall clinical and non-clinical development plan for approval. The Agency did suggest a change to the clinical development plan which will allow for faster and more efficient initiation of the pivotal testing, by introducing a small phase I study before the first phase III study, which includes a dose 3 times higher than previously tested in the phase II,” said Mary Tagliaferri, MD, Bionovo's president and chief medical officer.
“In order to reach higher efficacy we are evaluating the higher dose of Menerba in the first phase III trial. The FDA would like to see additional safety data to assess this dose. We had originally proposed to the FDA to use the first 60 patients enrolled in our first phase III study as subjects for safety evaluation. The protocol would have required enrollment to be suspended after 60 patients had been enrolled. Enrolment to study would continue only once an independent Data and Safety Monitoring Board (DSMB) had reviewed the safety data and deemed there were no safety issues,” continued Dr. Tagliaferri.
“However, the Agency instead recommended, and we agreed to conduct, a phase I study in advance of the phase III study. The phase I open label trial will enroll 20 postmenopausal women who will all receive Menerba 15g/day (7.5g BID) for 28 days. This approach will allow us to expedite the initiation of the phase III trial, since we will no longer have to halt enrollment after 60 patients are accrued to the trial to allow the DSMB to review safety data. We will be able to complete the phase I study at the same time the required 13-week animal toxicology studies are being conducted and while the phase III clinical trial material is manufactured and packaged,” concluded Dr. Tagliaferri.
We anticipate starting the phase I study in Q1, 2011 and beginning the phase III A pivotal trial in Q2, 2011.
“We are excited to move Menerba forward in the path to commercialization. Menerba is an important new treatment approach for millions of women suffering from menopausal hot flashes”, said Isaac Cohen, OMD, chairman and CEO of Bionovo. “The discussion with the FDA was also fruitful concerning future potential labelling of Menerba. Bionovo provided additional data to support our claim that Menerba is not an estrogen and not a SERM. The FDA acknowledged that Menerba is a selective estrogen receptor beta agonist. Granted we continue to show no safety concerns after the phase III trials, Menerba will provide a safer alternative to current hormone therapy.”
Menerba is an oral botanical 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 an alternative to the products currently on the market which have been shown to increase the risk for breast and uterine cancers. It has been shown that the increased risk of breast and uterine cancers is associated with activation of Estrogen Receptor alpha (ER-a) and that activation of ER-b blocks the growth promoting effects on breast cancer cells.
The active ingredients in Menerba are derived from botanicals with centuries of recorded safe, effective use in Traditional Chinese Medicine (TCM). Bionovo recognizes the opportunity to commercialize a product that would be as effective as hormone therapy, without the health risks.
Menerba has completed a phase II trial with positive results for efficacy and has been evaluated by an independent Data and Safety Monitoring Board and passed through a standard two-round examination for safety. Menerba also has been shown in animal studies to prevent the proliferation of breast cancer and to have a beneficial effect on osteoporosis, though this has not yet been studied in humans.
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.