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Phase 1 Results of Bionovo's Lead Compound, BZL101, Demonstrate Favorable Toxicity Profile and Evidence of Clinical Activity in Advanced Breast Cancer
Results Presented at San Antonio Breast Cancer Symposium
SAN ANTONIO and EMERYVILLE, Calif., Dec. 8 /PRNewswire-FirstCall/ -- Bionovo, Inc. (OTC Bulletin Board: BNVI.OB) today announced results from a Phase 1 clinical trial of BZL101, an oral drug candidate, in patients with refractory, metastatic breast cancer. The data, which were presented at the 28th Annual San Antonio Breast Cancer Symposium, showed that BZL101 has a favorable tolerability profile and demonstrates evidence of clinical activity in this patient group.
"We are encouraged by the results of this study, which underscore BZL101's low toxicity and highlight its potential as an effective new oral treatment for the more than 45,000 women who are diagnosed with this aggressive late stage of the disease each year," said Debu Tripathy, M.D., director of the Komen/UT Southwestern Breast Cancer Research Program at UT Southwestern Medical Center at Dallas and lead investigator of the study. "While safety was the primary endpoint of the trial, it is worth noting that BZL101 showed elements of clinical efficacy similar to what we observed in early stage studies of currently marketed therapies. Future studies are planned to further explore BZL101's activity."
The study was conducted by investigators at the Cancer Research Network in Plantation, Fla., Memorial Cancer Institute in Hollywood, Fla., the University of California, San Francisco, and UT Southwestern Medical Center at Dallas, in collaboration with scientists at Bionovo.
"Based on the promising data from our preclinical and Phase 1 clinical trial of BZL101, we are excited to initiate the Phase 2 program and hope to do so quickly," said Isaac Cohen, Bionovo's president and chief executive officer. "I believe this trial's results validate our unique approach to rapid drug development from bench to candidate selection to clinical trial design. Bionovo is committed to discovering and developing safe, novel therapies to treat metastatic breast cancer and filling this unmet medical need."
Study design and results
In this open-label trial, 21 patients with histologically confirmed metastatic breast cancer and measurable disease were treated with up to 12 gm in 350 ml solution per day of BZL101 until disease progression, toxicity or personal preference to discontinue treatment. Mean age was 54 years, and patients had failed an average of 3.9 prior treatment regimens for their advanced stage of the disease. Primary endpoints included safety and 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.
There were no hematologic or grade III or IV non-hematologic adverse events (AEs). All AE's were transient and did not require medical or pharmacological intervention.
Sixteen patients were evaluable for response. Four of the 16 patients had stable disease (SD) for >90 days (25%) and 3/16 had SD for >180 days (19%). Five patients had objective tumor regression, one of which was 1 mm short of a partial remission based on RECIST criteria.
About BZL101
BZL101, an oral drug designed for the treatment of breast cancer, specifically targets only malignant cells, leaving the normal cells intact and functioning. It is a standardized aqueous extract from herba Scutellaria Barbata D. Don of the Lamiaceae family. BZL101 is a compound that induces apoptosis through mitochondrial transmembrane potentiation. Specifically it translocates the AIF1 protein into the nucleus of the cell, causes chromatin condensation and DNA degradation, and leads to the cell's 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 over 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 drug development company focusing on the discovery of novel pharmaceutical agents for cancer and women's health. The company has two drugs ready to enter Phase 2 clinical testing, one for breast cancer therapy and another to treat conditions associated with menopause. The company is developing its products in close collaboration with leading U.S. academic research centers including the University of California, San Francisco; University of Colorado Health Sciences Center; University of California, Berkeley; and UT Southwestern. For further information please visit:
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 (SEC), which are available at
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.
San Antonio Breast Cancer Symposium Abstract Information
Tagliaferri M, Cohen I, Vogel C, Perez A, Tan Chui E, Franco S, Campbell M, Melisko M, Rugo H, Tripathy D. A phase I trial of Scutellaria Barbata (BZL101) for metastatic breast cancer. (Abstract #1079)
SOURCE Bionovo, Inc.
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Phase 1 Results of Bionovo's Lead Compound, BZL101, Demonstrate Favorable Toxicity Profile and Evidence of Clinical Activity in Advanced Breast Cancer.
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