EMERYVILLE, Calif., June 2 /PRNewswire-FirstCall/ -- Bionovo Inc. today announced results from a second ongoing clinical trial of BZL101, an oral drug candidate, in patients with refractory, metastatic breast cancer. The data, which were presented at the American Society of Clinical Oncology 44th Annual Meeting, showed that BZL101, at higher doses, continues to have a favorable safety and tolerability profile and shows ongoing evidence of clinical activity in women with advanced breast cancer.
“We are encouraged by the positive results of this second study which further underscores BZL101’s safety at higher doses and highlights its potential as an effective, novel, oral treatment for the more than 45,000 women who are diagnosed with this late stage breast cancer each year,” said lead author, Dr. Alejandra Perez, Director of the Breast Cancer Center at the Memorial Regional Hospital Cancer Institute. “While safety and maximum tolerability are the primary endpoints of the trial, BZL101 also showed early clinical efficacy, including one patient who has been stable for 13 months and shows radiographic evidence of tumor shrinkage.”
The study is being conducted by investigators at Duke University, Columbia Presbyterian Medical Center, University of Chicago, University of Texas Southwestern Medical Center, Ohio State University, Montefiore Medical Center, Cancer Research Network and Memorial Regional Cancer Institute in collaboration with scientists at Bionovo. The study is a Phase 1/2 trial, and is currently in the Phase 1 Dose Escalation component, and is expected to progress to the Phase 2 component and full recruitment during the third quarter of this year.
“Based on the promising data from the early clinical trials of BZL101, we are excited to transition to our FDA-approved Phase 2 program later this year,” said Isaac Cohen, Bionovo’s Chairman and Chief Executive Officer. “I believe this trial’s results further validate the potential for a novel, oral anticancer drug with a unique mechanism of action that selectively target cancer cells without affecting normal cells as evidenced by our low toxicity and early clinical efficacy. Due to BZL101’s favorable results to date, Bionovo will consider studying BZL101 as the first non-hormonal, oral adjuvant for early breast cancer.”
Study Design and Results
In this open-label, dose escalation trial, 20 patients with histologically confirmed metastatic breast cancer and measurable disease were treated with oral BZL101 until disease progression or toxicity. Mean age was 60 years and patients had failed an average of 3.1 prior chemotherapy treatment regimens since diagnosis with metastatic breast cancer. Primary endpoints of the study include safety, toxicity and tumor response as defined by RECIST (Response Evaluation Criteria In Solid Tumors), a set of published criteria that determine when a tumor responds, remains stable or progresses.
The trial is currently ongoing and three different doses of BZL101 have been found to be safe and well tolerated. A fourth cohort of patients is currently being enrolled to the trial in order to determine the maximum tolerated dose that will be tested in the Phase 2 clinical trial later this year. There were no serious adverse events (SAEs) associated with BZL101 treatment. Patients were able to tolerate BZL101 therapy well and compliance with treatment was 93% of prescribed doses. The most frequently reported BZL101-related adverse events were: diarrhea (40%), nausea (30%), headache (20%), and increased amino alanine transferase (20%).
Twelve patients were evaluable for response according to RECIST. Five of the 12 patients had stable disease (SD) for >90 days (42%) and one patient, currently on study, has had SD for >170 days. An additional patient has been stable for 13 months and had radiographic evidence of tumor shrinkage.
About BZL101
BZL101 is an oral drug designed for the treatment of breast cancer that targets only cancer cells, leaving the normal cells intact and functioning. BZL101 is an aqueous extract from herba Scutellaria Barbata D. Don of the Lamiaceae family. BZL101 is a compound that induces cell death due to attenuation of mitochondrial transmembrane potential (MTP) leading to the release of reactive oxygen species, causing inhibition of glycolysis and ending with induction of DNA damage and cell death. There are currently no effective therapeutic cures for advanced breast cancer and treatment is primarily aimed at palliation of symptoms as well as improving overall survival. Breast cancer is the second leading cause of cancer death with approximately 200,000 new cases per year. Although survival after breast cancer treatments is improving, there are still more than 40,000 deaths per year due to breast cancer.
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.
CONTACT: Investors, Lauren Glaser of The Trout Group, +1-415-392-3310,
lglaser@troutgroup.com, For Bionovo Inc.; or Media, Tom Chesterman of
Bionovo Inc., +1-510-420-4189, investor@bionovo.com
Web site: http://www.bionovo.com/
