Navigation Links
Sanofi-aventis Reports Top-line Results from Phase III Study with Iniparib (BSI-201) in Metastatic Triple-Negative Breast Cancer

BRIDGEWATER, N.J., Jan. 27, 2011 /PRNewswire/ -- Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) and its subsidiary, BiPar Sciences, today announced that a randomized Phase III trial evaluating iniparib* (BSI-201) in patients with metastatic triple-negative breast cancer (mTNBC) did not meet the pre-specified criteria for significance for co-primary endpoints of overall survival and progression-free survival.

Importantly, the results of a pre-specified analysis in patients treated in the second- and third-line setting demonstrate an improvement in overall survival and progression-free survival, consistent with what was seen in the Phase II study. The overall safety analysis indicates that the addition of iniparib (BSI-201) did not significantly add to the toxicity profile of gemcitabine and carboplatin.

"While this trial did not meet its primary goal, we believe that the improvement in overall survival and progression-free survival in patients in the second- and third-line setting are important findings," said Dr. Debasish Roychowdhury, Senior Vice President and Head of sanofi-aventis Oncology. "We are conducting in-depth analysis to gain further insight into these Phase III results. Sanofi-aventis remains committed to improving outcomes for patients with triple-negative breast cancer where there is high unmet medical need."

Sanofi-aventis plans to discuss these data with United States and European health authorities in the near future. Full study results will be presented at an upcoming major oncology conference.  Patients with questions are encouraged to consult with their treating physicians, or call 1-800-633-1610. The current clinical development program for iniparib (BSI-201) continues in breast, lung and other cancers.

About the Iniparib Phase III Study

The study enrolled 519 women with mTNBC from 109 sites in the United States. Patients were randomized to receive a standard chemotherapy regimen (gemcitabine and carboplatin) on days one and eight of each 21-day cycle, with or without iniparib (BSI-201) 5.6 mg/kg, which was administered on days one, four, eight and 11 of each 21-day cycle. Patients in the study had received up to two previous lines of chemotherapy in a metastatic setting. The co-primary endpoints were overall survival and progression-free survival.

About Iniparib

Iniparib (BSI-201) is a novel investigational anti-tumor agent with poly (ADP-ribose) polymerase (PARP) inhibitory activity in preclinical models. Iniparib (BSI-201) is in Phase III trials for patients with squamous non-small cell lung cancer, as well as in Phase II trials for patients with breast, lung and other cancers.

* Iniparib is the United States Adopted Name (USAN) for the investigational agent BSI-201.

About Triple-Negative Breast Cancer (TNBC)

When women are diagnosed with breast cancer, their tumors are routinely tested for the presence of estrogen and progesterone receptors and for the over-expression of HER2. However, 15 to 20 percent of all breast cancers lack over-expression of all three proteins – giving rise to the term "triple-negative breast cancer" or TNBC. Research has shown TNBC continues to be difficult to treat and associated with poorer outcomes than other types of breast cancer. Women with TNBC are not candidates for hormonal therapies such as tamoxifen or therapies targeting the human epidermal growth factor receptor 2, such as Herceptin, leaving chemotherapy as the standard treatment. Therefore, finding new strategies to enhance the effectiveness of chemotherapy in this population has become an important research focus.

About BiPar Sciences

BiPar Sciences is a biopharmaceutical organization dedicated to pioneering novel tumor-selective therapies designed to address urgent unmet needs of cancer patients. Located in South San Francisco, California, BiPar is a subsidiary of sanofi-aventis. For more information, please visit

About sanofi-aventis Oncology

Based in Cambridge, Massachusetts, and Vitry, France, sanofi-aventis Oncology is translating science into effective cancer therapeutics to address unmet medical needs for patients with cancer. Starting with a deep understanding of the mechanisms by which cancer develops, grows and spreads, the company employs innovative approaches in drug discovery, clinical development and partnerships to bring the right medicines to the right patients with the goal of helping cancer patients live healthier and longer lives.

Sanofi-aventis Oncology is committed to the pursuit of science and innovative cancer therapies. We believe in partnership with leading experts, and combining that expertise with our own internal scientific strength and heritage. There are currently more than 10 investigational compounds in clinical development including small molecules and biological agents.

About sanofi-aventis

Sanofi-aventis U.S. is an affiliate of sanofi-aventis, a leading global pharmaceutical company that discovers, develops and distributes therapeutic solutions to help improve the lives of patients. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

For more information, or

Forward-Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans" and similar expressions. Although sanofi-aventis' management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of sanofi-aventis, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labeling and other matters that could affect the availability or commercial potential of such products candidates, the absence of guarantee that the products candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, the Group's ability to benefit from external growth opportunities as well as those discussed or identified in the public filings with the SEC and the AMF made by sanofi-aventis, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in sanofi-aventis' annual report on Form 20-F for the year ended December 31, 2009. Other than as required by applicable law, sanofi-aventis does not undertake any obligation to update or revise any forward-looking information or statements.

SOURCE sanofi-aventis
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Reportlinker Adds Sanofi-Aventis: PharmaVitae Profile
2. Sanofi-aventis Oncology Data to be Presented at San Antonio Breast Cancer Symposium
3. Sanofi-aventis Sends Letter to Genzyme Seeking Clarification on Potential Board Actions
4. Covance and sanofi-aventis Finalize Agreements for 10-year Strategic R&D Alliance
5. Sanofi-aventis to Acquire BMP Sunstone Creating a Strong Consumer Healthcare Platform in China
6. Sanofi-aventis Initiates Phase III Study with Teriflunomide as Adjunct Therapy with Interferon Beta to Further Explore Clinical Benefits in Multiple Sclerosis
7. Sanofi-aventis Commences Tender Offer to Acquire All Outstanding Shares of Genzyme for $69 per Share in Cash
8. Covance and Sanofi-Aventis Sign Definitive Agreements for 10-Year Strategic R&D Alliance
9. European Hospital Anticoagulant Market Dominated by Sanofi-Aventiss Clexane
10. Reportlinker Adds Sanofi-Aventis: PharmaVitae Profile
11. Sanofi-aventis Announces Non-Binding Offer to Acquire Genzyme
Post Your Comments:
(Date:11/25/2015)... Endo International plc (NASDAQ: ENDP ) (TSX: ... and CEO, will discuss corporate updates at the 27 th ... York on Wednesday, December 2, 2015 at 1 ... Relations, and then the link to the event. Participants should ... to visit the site and download any streaming media software ...
(Date:11/25/2015)... Asia -based venture ... and the New Investors will make a direct equity ... private placement. The financing will help IOPtima to continue ... in the treatment of glaucoma, as well as to ... system with the U.S. Food and Drug Administration, commencing ...
(Date:11/25/2015)... PHILADELPHIA, Pennsylvania , November 25, 2015 ... Continuing Medical Education (CME) --> ... Care Continuing Medical Education (CME) ... -of- Care Continuing Medical Education (CME) ... and medical information products and services, will feature latest diagnostic imaging ...
Breaking Medicine Technology:
(Date:11/26/2015)... ... November 26, 2015 , ... WorldCare International, Inc., ... the 61st annual Employee Benefits Conference. The Employee Benefits Conference was hosted by ... through Wednesday, November 11th, 2015. The conference was held at the Hawaii Convention ...
(Date:11/25/2015)... ... November 25, 2015 , ... As part ... For Empowerment ™ attracts volunteers together who want to combine talents and resources ... key stakeholders in the process. The non-profit launched its first major fundraiser on ...
(Date:11/25/2015)... ... November 25, 2015 , ... Dr. John Pierce, Medical Director ... about hair loss treatment with the Capillus272™ Pro laser therapy cap. FDA cleared for ... and fuller hair, without the need for surgery, prescription pills, or topical foams. ...
(Date:11/25/2015)... ... November 25, 2015 , ... Lakeview Health, a Jacksonville-based drug ... their sobriety and show through pictures what a positive difference it makes. The ... with the hashtag #FacesOfGratitude on their Facebook, Twitter, and Instagram accounts. Short ...
(Date:11/25/2015)... ... 25, 2015 , ... On November 23rd 2015 Cozy Products, a ... products business. Cozy Products explains what this means for business moving forward. , The ... Cozy Products business model: to sell personal heaters that reduce energy consumption, are economical ...
Breaking Medicine News(10 mins):