Bezielle (BZL101) Clinical Trial
Trial Status: Open to Recruitment

Background

• Over 200,000 women in the US are diagnosed with breast cancer every year.
• Breast cancer is the 2nd leading cause of cancer deaths for women.
• Current treatments lead to intolerable side effects and ineffective control of advanced breast cancer symptoms.
• Therapies with minimal side effects are urgently needed.

About Bezielle

• Bezielle is an oral botanical drug designed for the treatment of breast cancer that targets only cancer cells but leaves normal cells intact and functioning.
• Bionovo, Inc completed a preliminary trial to determine the side effects from Bezielle treatment and to determine if Bezielle is effective in the treatment of metastatic breast cancer .

Results of the preliminary trial:

• 21 women with metastatic breast cancer enrolled.
• On average, the group of women enrolled to the trial had been on 4 prior treatments for metastatic disease prior to starting Bezielle therapy.
• 16 women on the trial were evaluable for response: 
• 4 women had stable disease >90 days
• 3 women had stable disease for >180 days
• 1 woman was 1 mm short of a partial remission

Results published in: Breast Cancer Research and Treatment and tagged as a “Critical Trial” 
Read the article [Adobe Acrobat PDF [232 KB]

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Who is eligible to participate?

• Phase I:
• Up to 20 women with histological stage IV metastatic breast cancer
• Phase II, 80 women total with histological stage IV metastatic breast cancer
• 40 women with hormone receptor positive disease
• 40 women with hormone receptor negative disease

Key Inclusion Criteria:

• Women 18 years or older
• Histologically confirmed breast cancer
• Clinical evidence of metastatic (stage IV) metastasis (other than bone metastasis)
• Availability of estrogen receptor and HER2 over-amplification status
• At least one measurable disease site defined by RECIST criteria, 30 days prior to study therapy
• For the phase 2 only, no more than 2 prior cytotoxic treatments for breast cancer 
• Life expectancy ≥ 12 weeks
• Women of child bearing potential must agree to 2 forms of contraception during the course of the trial.

• Inability to understand/unwillingness to sign a written informed consent
• Treatment within 6 weeks of study entry with antibodies/immunotherapy
• Treatment within 2 weeks of study entry with chemotherapy, radiotherapy or any investigational agents
• Currently using an investigational agent
• Bisphosphonate therapy started within 4 weeks of study treatment
• Women who report pregnancy, are breast-feeding or have a positive pregnancy test

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Study Centers:

Bionovo, Inc has selected trial sites throughout the continental United States. For participation in the Bezielle trial please contact the Principal Investigator listed at the site nearest to you. 

Study Centers currently include locations in:Florida, Illinois, Massachusetts, New York, North Carolina, Ohio and Texas

If you cannot find a site near you please complete the following form and a Bionovo, Inc representative will contact you as soon as possible. (Click here for contact form)

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Additional resources on Clinical Trials and Breast Cancer:

Breast Cancer Resource Sites

• Breast Cancer Site: Provides breast cancer survivors with accurate information about everything from post-surgery options and products to information about insurance and intimacy issues.
• Living Beyond Breast Cancer: A non-profit educational organization committed to empowering all women affected by breast cancer to live as long as possible with the best quality of life.
• Susan Love website: Information on risk, prevention, and treatment for primary and metastatic breast cancer, as well as issues and information relevant to menopause, hormone replacement therapy, and other mid-life health issues.

Find out more about Clinical Trials

• Background Information on Clinical Research
• What is a Clinical Trial?

About the Trial Sponsor, Bionovo:
Bionovo is a publicly traded pharmaceutical company focused on discovering and developing drugs for women's health and cancer.  The company is working simultaneously on two distinct discovery approaches, one focusing on pro-apoptotic agents for cancer and a second, in the area of selective estrogen receptor modulators (SERMS) to treat severe menopausal symptoms. Both approaches are highly selective to yield products that will effectively and safely address these areas of high unmet need.  The company's clinical development strategy leverages relationships with key faculty at leading research institutions to conduct trials with recognized opinion leaders. 

To obtain more information on Bionovo, Inc., please visit our website: www.bionovo.com

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