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“There is great patient demand for an oral drug with minimal toxicity among women diagnosed with late stage breast cancer.  Bezielle is the exact type of drug that our patients are seeking and the favorable clinical results in 2 different trials among a heavily pretreated patient population are extremely encouraging.”

–Debu Tripathy, M.D.
Industry Opinion Leader, National PI on the Herceptin Trial, Breast Oncologist, University of Texas Southwestern, Dallas, Texas

 

 

“In the age of sequential monotherapy as the treatment approach for the treatment of women with metastatic breast cancer, Bezielle is one of the most exciting new therapies under investigation today.”

–Banu Arun, M.D.
Department of Breast Medical Oncology, Division of Cancer Medicine, The University of Texas M. D. Anderson Cancer Center, Houston, Texas

Bezielle® for the Treatment of Advanced Breast Cancer

Bezielle Logo

Background

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. Approximately 200,000 women are diagnosed with breast cancer each year and breast cancer is the second leading cause of cancer death among women. Although survival after breast cancer treatment is improving, there are still over 40,000 deaths per year due to the disease. The annual market for drugs targeted at this disease is estimated at $7 billion.

Mechanism of Action

Bezielle is an oral drug designed for the treatment of advanced breast cancer with a novel mechanism of action. Bezielle targets diseased cells while leaving normal cells healthy and intact. Normal cells depend primarily on the citric acid cycle (>85%) and very little on glycolysis (<7%) for energy production. In contrast, cancer cells depend largely on glycolysis (>85%) for energy production. Bezielle induces strong oxidative stress in cancer cells leading to severe DNA damage, but in normal cells the effect is blunted due to their different metabolic profile.  Cancer cells attempt but ultimately fail to repair DNA damage that results in the inhibition of glycolysis  and cancer cell death while normal cells remain unharmed.

Selective Cytotoxic Activity

Bezielle is selectively cytotoxic to most of twelve breast cancer cell lines examined, as well as to a number of cancer cell lines of different tissue origins such as prostate, lung, colon and pancreatic cancers. At the same dose, Bezielle does not induce appreciable cell death in normal cells such as fibroblasts and normal mammary epithelial cells and lines. Bezielle was also orally active in preventing tumor formation in a mouse xenograph model.

Phase 1 Clinical Results

Bionovo’s lead cancer candidate has been evaluated in two Phase 1 clinical trials and a total of 47 women with advanced breast cancer have been treated with Bezielle. Data from the Phase 1 clinical trials of Bezielle show promising signs of efficacy and indicate the drug is well tolerated and safe for clinical use.

Next Steps: Phase 2 Clinical Trial

A multi-center, Phase 2, open-label, non-randomized clinical trial to assess ongoing safety and preliminary efficacy of Bezielle for the treatment of metastatic breast cancer is being conducted under the co-directorship of Dr. Banu Arun of the M.D. Anderson Cancer Center and Alejandra Perez of the Memorial Cancer Institute. A total of 80 women with histologically confirmed breast cancer and measurable stage IV disease will be enrolled to the Phase 2 trial. Of the 80 women, 40 will have hormone receptor-positive disease and 40 will have hormone receptor-negative disease. The primary outcome measure will be response to therapy evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST).  Secondary measures of efficacy will include: duration of overall objective response, progression-free survival, overall survival, and patient reported quality of life measures.  Recruitment for the clinical trial will take place at 20 clinical sites throughout the United States. Click here to visit Bionovo's Bezielle clinical trial website.

About the Co-Principal Investigators

Banu Arun, M.D.
Co-Medical Director, Cancer Prevention Division, Department of Clinical Cancer Prevention, M.D. Anderson Cancer Center

Dr. Arun holds appointments in two important departments of the M.D. Anderson Center, Associate Professor of Breast Medical Oncology and Co-Medical Director of the Cancer Prevention Division. Dr. Arun received her medical degree and residency training from the University of Istanbul and completed a fellowship in Hematology and Oncology at the Vincent T. Lombardi Cancer Center in Washington, D.C.

Dr. Arun’s research interests are focused on identifying risk markers for breast cancer in breast tissue and serum/blood, evaluation of potential breast cancer prevention agents, and characterizing breast cancers in individuals with our without the BRCA mutation. She is currently the principal investigator on a pilot study evaluating the significance of the HER2/neu 1655V polymorphism in Hispanic women with breast cancer and women who are at increased risk to develop breast cancer. She also serves as principal investigator on the Lynne Cohen High Risk Screening & Prevention Project for Ovarian & Breast Cancer.

Alejandra Perez, M.D.
Director, Memorial Cancer Institute Breast Cancer Centers

Dr. Perez acquired her medical degree at the Health Science Institute in Colombia, graduating among the top 10 in her class. She completed her training in internal medicine at Danbury Hospital, an affiliate of Yale University School of Medicine. After completing her residency, she was appointed Chief Resident in the ambulatory care setting. She also completed her hematology and oncology fellowship training at Albert Einstein College of Medicine and Montefiore Medical Center in New York.

Dr. Perez is board-certified in internal medicine, hematology and oncology. She is Director of the Breast Cancer Centers at Memorial Cancer Institute where she is primary investigator on numerous clinical trials addressing the prevention and treatment of breast cancer. Her philosophy of care is to treat the individual, completely, including body, mind and spirit with focus on expert disease management whether intent is toward cure, surveillance or control of the breast cancer.