Bionovo reports positive Menerba clinical program meeting with FDA

Dec 13 2010

Bionovo, Inc. (Nasdaq: BNVI), a pharmaceutical company focused on the discovery and development of innovative treatments for women's health and cancer, today announced that it had received the minutes from the U.S. 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 program 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 1 study before the first Phase 3 study, which includes a dose 3 times higher than previously tested in the Phase 2," said Mary Tagliaferri, M.D., 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 3 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 3 study as subjects for safety evaluation. The protocol would have required enrollment to be suspended after 60 patients had been enrolled. Enrollment 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 1 study in advance of the Phase 3 study. The Phase 1 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 3 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 1 study at the same time the required 13-week animal toxicology studies are being conducted and while the Phase 3 clinical trial material is manufactured and packaged," concluded Dr. Tagliaferri.

We anticipate starting the Phase 1 study in Q1, 2011 and beginning the Phase 3A 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, O.M.D., Chairman and CEO of Bionovo. "The discussion with the FDA was also fruitful concerning future potential labeling 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 3 trials, Menerba will provide a safer alternative to current hormone therapy."