BRIDGEWATER, N.J., Dec. 9, 2010 /PRNewswire-FirstCall/ -- Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today that the final survival analysis (10-year follow-up) of the BCIRG001 study that included a Taxotere® (docetaxel) Injection Concentrate chemotherapy treatment regimen in the adjuvant breast cancer setting, as well as data from iniparib (BSI-201) pre-clinical and clinical breast cancer studies will be featured during the 33rd Annual San Antonio Breast Cancer Symposium (SABCS) in San Antonio, Texas from December 8 to 12, 2010.
During SABCS, the final (10-year follow up) survival analysis of the BCIRG001 study that included sanofi-aventis' chemotherapy drug Taxotere, in combination with doxorubicin and cyclophosphamide, in women with operable node-positive breast cancer will be presented. Also being presented are data from pre-clinical and clinical studies involving the sanofi-aventis investigational compound iniparib (BSI-201), which is being studied in breast cancer. Iniparib is a novel investigational small molecule with poly (ADP-ribose) polymerase (PARP) inhibitory activity.
Key events at SABCS include: Taxotere Data:Abstract #S4-3
Friday, Dec. 10
3:45 PM CSTAn oral presentation featuring final results from the ten-year follow-up analysis of the BCIRG 001 trial Iniparib Data:Abstract #P5-06-09
Phase 1b/2 MBC trial
Saturday, Dec. 11
5:30 - 7:30 PM CSTData from a Phase 1b study to assess the safety and tolerability of the investigational compound iniparib (BSI-201) in combination with irinotecan in patients with metastatic breast cancer (MBC)Iniparib Data:Abstract # P6-04-12
Activity in TNBC Cell lines
Sunday, Dec. 12
7:00 - 8:30 AM CSTData from a preclinical study assessing the cell cycle effects of the investigational compound iniparib (BSI-201) in combination with gemcitabine and carboplatin in the MDA-MB-468 (-) Triple Negative Breast Cancer (TNBC) cell lineIniparib Data:Abstract # P6-15-01
Gene pathway analysis of
primary TNBC tumors
Sunday, Dec. 12
7:00 - 8:30 AM CSTData from a preclinical study characterizing the pathways of primary human triple-negative breast cancersAbout Iniparib (BSI 201)Iniparib (BSI-201), the United States Adopted Name (USAN) for BSI-201, is a novel investigational small molecule with poly (ADP-ribose) polymerase (PARP) inhibitory activity.
BiPar Sciences and sanofi-aventis are pursuing a broad development program with iniparib in breast cancer and multiple trials are planned to start in the next several months. A Phase 3 trial in mTNBC is ongoing, and multiple new trials are planned to start in the next several months. New trials include:
Iniparib also in being studied in a Phase 3 trial for patients with squamous non-small cell lung cancer, and in Phase 2 trials for patients with ovarian, uterine and brain cancers. The regulatory submissions are planned for Q1 2011 in the U.S. and Q2 2011 in the European Union.
About Taxotere (docetaxel) Injection ConcentrateIntroduced more than 14 years ago, Taxotere is approved for use in the following indications:
Non-Small Cell Lung Cancer:
Head and Neck Cancer:
Important Safety Information for Taxotere® (docetaxel) Injection ConcentrateWARNING
For more information about Taxotere, including full prescribing information and product boxed WARNING, visit: http://products.sanofi-aventis.us/taxotere/taxotere.pdf
About sanofi-aventis Oncology Sanofi-aventis Oncology is targeting cancer on several fronts in an effort to address unmet medical needs for a broad range of patients. Starting with a deep understanding of the mechanisms by which cancers develop, grow and spread, as well as translating this deep scientific understanding early in the drug discovery process, the company employs innovative approaches to bring the right medicines to the right patients. Compounds are now being investigated in Phase III clinical studies aimed at multiple solid and hematologic tumor types.
About sanofi-aventisSanofi-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, visit www.sanofi-aventis.us or www.sanofi-aventis.com.
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 wholly owned subsidiary of sanofi-aventis. For more information, please visit www.biparsciences.com.
Forward Looking StatementsThis 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 labelling 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.
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