BRIDGEWATER, N.J., May 29, 2007 /PRNewswire-FirstCall/ -- Sanofi-aventis announced today that a total of 375 abstracts indicative of its oncology commitment have been accepted for the 43rd Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, Illinois (June 1-5, 2007). The results from key studies involving the company's leading anticancer agents, Eloxatin(R) (oxaliplatin injection) and Taxotere(R) (docetaxel injection concentrate), will be presented alongside clinical trial data examining investigational agents, aflibercept (VEGF Trap), S-1 (oral fluoropyrimidine) and TroVax(R) (Therapeutic Cancer Vaccine).
Of the abstracts which have been accepted, 129 focus on Eloxatin(R), 214 on Taxotere(R), 29 on S-1, two on VEGF Trap and one on TroVax(R). One hundred and ninety three Eloxatin(R) and Taxotere(R) abstracts were also accepted for presentation at the scientific sessions, with five Eloxatin(R) and 15 Taxotere(R) abstracts to be oral communications, including one Eloxatin(R) presentation at the ASCO plenary session.
The key results presented with Eloxatin(R)-based treatment (in combination with 5FU/LV) cover clinical trials in the adjuvant (post-surgery) colon cancer (MOSAIC study) and the metastatic (advanced) colorectal cancer (NCCTG/N9741study, EORTC40983/EPOC study) settings.
Data looking at Taxotere(R)-based regimens in adjuvant and in metastatic breast cancer will be presented during the meeting.
Two phase II studies examined aflibercept (VEGF Trap) as a single agent in recurrent ovarian and lung cancers. VEGF Trap is an anti-angiogenic agent that blocks the Vascular Endothelial Growth Factor (VEGF), and is currently being investigated to assess its use in stopping tumor growth. Aflibercept is in phase nausea, vomiting, hair loss, rash, infusion-site reactions, odd sensations (such as numbness, tingling, or burning) or weakness in the hands and feet, nail changes, muscle and/or bone pain, or excessive tearing.
Because of the potential risk of fetal harm, pregnant women should not receive Taxotere(R). Women of childbearing potential should avoid becoming pregnant during treatment with Taxotere(R).
Before receiving Taxotere(R), tell your doctor if -- You have any allergies -- You are taking any other medicines - including nonprescription (over- the-counter) drugs, vitamins, and dietary or herbal supplements When taking Taxotere(R), contact your doctor if -- You have symptoms of an allergic reaction (warm sensation, tightness in your chest, itching/hives, or shortness of breath) -- You experience any other side effects
For full prescribing information, including boxed WARNING, call 800-633-1610 or visit http://www.taxotere.com.
Sanofi-aventis is one of the world leaders in the pharmaceutical industry, ranking number one in Europe. Backed by a world-class R&D organization, sanofi-aventis is developing leading positions in seven major therapeutic areas: cardiovascular, thrombosis, oncology, metabolic diseases, central nervous system, internal medicine and vaccines. Sanofi-aventis is listed in Paris and in New York .
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 financial projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future events, operations, products and services, and statements reg arding 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 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, 2006. Other than as required by applicable law, sanofi-aventis does not undertake any obligation to update or revise any forward-looking information or statements.
Contact: Noelle Boyd, sanofi-aventis, (908) 981-6489
Lisa Kennedy, sanofi-aventis, (908) 981-6569
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S-1 is a novel oral fluoropyrimidine that combines three investigational agents: tegafur, a pro-drug of 5 fluoro-uracil; gimeracil (5-chloro-2,4 dihydropyridine) which inhibits dihydropyrimidine dehydrogenase enzyme; and oteracil (potassium oxonate), a gastrointestinal side effect corrector. The Phase III data to be presented evaluate the addition of cisplatin to S-1 in advanced gastric cancer. S-1 is marketed in Japan by Taiho for a variety of indications including gastric cancer. Sanofi-aventis is leading the development of the compound outside of Japan and in some Asian countries.
TroVax(R) is a therapeutic cancer vaccine developed in collaboration with Oxford BioMedica. It targets the tumor antigen 5T4, broadly distributed in a wide range of solid tumors. The presentation will include new data from two Phase II trials of TroVax(R) in renal cancer.
Finally, the first outcomes of the innovative program "My Child Matters," a unique humanitarian pediatric cancer initiative in developing countries co- sponsored by sanofi-aventis and the International Union Against Cancer (UICC), will be presented.
Details on the key studies to be presented at the meeting during podium presentations and poster discussions are as follows:
Eloxatin(R) (oxaliplatin injection) clinical studies:
Abstract # 4007 - Oxaliplatin/5FU/LV in the adjuvant treatment of colon cancer: updated efficacy results of the MOSAIC trial, including survival, with a median follow-up of 6 years.
-- A long-term update including disease-free-survival and overall survival data from the MOSAIC study, which evaluates the role of oxaliplatin/5FU/LV (FOLFOX4) as adjuvant treatment for stage II and III colon cancer, will be presented. -- Sunday, June 3, 8:15 AM - 8:30 AM, E Arie Crown Theatre, Oral Presentation.
Abstract # 4067 - N9741: Survival update and prognostic factor analysis of oxaliplatin (ox) and irinotecan (iri) combinations in patients with metastatic colorectal cancer (MCRC).
-- An updated analysis of the phase III N9741 study evaluating FOLFOX4 versus irinotecan-based chemotherapy in metastatic colorectal cancer patients will be presented. -- Monday, June 4, 8:00 AM - 12:00 PM, S Hall A2, Poster Presentation.
Abstract # LBA5 - Final results of the EORTC Intergroup randomized phase III study 40983: Peri-operative FOLFOX4 chemotherapy and surgery for resectable liver metastases from colorectal cancer.
-- The study examines the use of chemotherapy with oxaliplatin/5FU/LV (FOLFOX4) given before and after surgery of liver metastases from metastatic colorectal cancer versus surgery alone. Eloxatin(R) for peri-operative use is not in the U.S. label. -- Monday, June 4, 3:30 PM - 3:45 PM, N Hall B1, Plenary Session.
For information about currently approved uses of Eloxatin(R), please see full prescribing information.
Taxotere(R) (docetaxel) Injection Concentrate clinical studies:
Abstract # LBA1008 - BCIRG007: First overall survival analysis of a randomized phase III trial of trastuzumab plus docetaxel with or without carboplatin as first line therapy in HER2 amplified metastatic breast cancer (MBC).
-- This study evaluates the use of two Taxotere(R) - Herceptin (trastuzumab) regimens for the treatment of metastatic HER2 positive breast cancer patients. -- Sunday, June 3, 9:45 AM - 10:00 AM, N Hall B1, Oral Presentation.
Abstract #537 - Estrogen receptor expression and efficacy of docetaxel in early breast cancer: A pooled analysis of 3490 patients included in two randomized trials.
-- This presentation reviews the use of Taxotere(R) in trials involving patients with early stage node positive breast cancer, accor ding to the hormonal receptor status of the tumor. -- Monday, June 4, 10:00 AM - 10:15 AM, E Hall D1, Oral Presentation. Investigational Agents:
Abstract # 5508 - VEGF Trap for patients (pts) with recurrent platinum- resistant epithelial ovarian cancer (EOC): Preliminary results of a randomized, multicenter phase II study.
-- Data on the use of aflibercept (VEGF Trap) as a single agent in recurrent ovarian cancer will be presented. -- Sunday, June 3, 2:45 PM - 3:00 PM, E 354a, Oral Presentation.
Abstract # 7627 - Phase II study of the efficacy and safety of Intravenous (IV) AVE0005 (VEGF Trap) given every two weeks in patients (pts) with platinum and erlotinib-resistant adenocarcinoma of the lung (NSCLA).
-- Data on the use of aflibercept (VEGF-Trap) as a single agent in refractory NSCLA will be presented. -- Sunday, June 3, 8.00 AM - 12:00 PM, S Hall A2, General Poster Session.
Abstract # 4514 - Randomized phase III study of S-1 alone versus S-1 plus CDDP in advanced gastric cancer (the SPIRITS trial).
-- This study evaluated the addition of cisplatin to S-1 versus S-1 alone in advanced gastric cancer. -- Sunday, June 3, 5:00 PM - 5:15 PM, E Hall D2, Oral Presentation.
Abstract # 3069 - Activity of MVA 5T4 alone or in combination with either interleukin-2 or interferon-alpha in patients with metastatic renal cell cancer.
-- The trials are designed to evaluate TroVax either as a single agent, or in combination with either interleukin-2 or interferon-alpha. -- Sunday, June 3, 8:00 AM - 12:00 PM, S Hall A2, General Poster Session. "My Child Matters" program:
Abstract # 9526 - My child matters program: A UICC-sanofi-aventis partnership to improve paediatric cancer care in developing countries.
-- First outcomes of the humanitarian program focused on children with cancer in the developing world will be presented in this presentation. -- Sunday, June 3, 2:00 PM - 6:00 PM, S Hall A2, Poster Number W2. About Eloxatin(R) Indications and Usage
Eloxatin(R) (oxaliplatin for injection), a DACH platinum, is approved in combination with infusional 5-FU/LV for the second-line treatment of patients with advanced carcinoma of the colon or rectum. In 2004, Eloxatin received additional approval for the first-line treatment of these patients. Based on data showing improvement in disease-free survival, Eloxatin was also approved in 2004 for use in combination with infusional 5-FU/LV in adjuvant (post- surgery) treatment of stage III colon cancer patients.
Clinical Safety Considerations
Eloxatin(R) should be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents.
Appropriate management of therapy and complications is possible only when adequate diagnostic and treatment facilities are readily available.
Anaphylactic-like reactions to Eloxatin(R) have been reported and may occur within minutes of Eloxatin(R) administration. Epinephrine, corticosteroids, and antihistamines have been employed to alleviate symptoms, and discontinuation of Eloxatin(R) therapy may be required.
-- Eloxatin(R) should not be administered to patients with a history of known allergy to Eloxatin(R) or other platinum compounds. Hypersensitivity and anaphylactic/anaphylactoid reactions to Eloxatin(R) have been reported and were similar in nature and severity to those reported with other platinum compounds (ie, rash, urticaria, erythema, pruritus, and, rarely, bronchospasm and hypotension). These reactions occur within minutes of administration and should be managed with appropriate supportive therapy. Drug-related deaths from this reaction have been reported -- Eloxatin(R) may cause fet al harm when administered to a pregnant woman. Women of childbearing potential should be advised not to become pregnant while receiving Eloxatin(R). It is not known whether Eloxatin(R) or its derivatives are excreted in human milk -- Eloxatin(R) has been associated with pulmonary fibrosis (<1% of study patients), which may be fatal. The combined incidence of cough and dyspnea was 7.4% (<1% grade 3, no grade 4) in the Eloxatin(R) plus 5- FU/LV arm compared to 4.5% (no grade 3, 0.1% grade 4) in the 5-FU/LV alone arm in the adjuvant colon cancer study. In this study, one patient died from eosinophilic pneumonia in the Eloxatin(R) combination arm. The combined incidence of cough, dyspnea, and hypoxia was 43% (7% grade 3 and 4) in the Eloxatin(R) plus 5-FU/LV arm compared to 32% (5% grade 3 and 4) in the irinotecan plus 5-FU/LV arm in patients with previously untreated colorectal cancer. In case of unexplained respiratory symptoms, Eloxatin(R) should be discontinued until pulmonary investigation excludes interstitial lung disease or pulmonary fibrosis -- Eloxatin(R) is associated with two types of primarily peripheral sensory neuropathy: an acute, reversible type of early onset and a persistent type (>14 days). In patients with advanced colorectal cancer paresthesias occurred in 77% (all grades) and 18% (grade 3/4) of previously untreated patients. In previously treated patients, acute neuropathy occurred in 56% (all grades) and 2% (grade 3/4) of patients; persistent neuropathy occurred in 48% (all grades) and 6% (grade 3/4) of patients. In patients with stage II and III colon cancer, paresthesia was seen in 92% (all grades) and 13% (grade 3/4) of patients; 21% (all grades), 0.5% (grade 3/4) had residual paresthesia at 18-month follow-up -- Hepatotoxicity, as evidenced in the adjuvant study by increase in transaminases and alkaline phosphatase was observed more commonly in the Eloxatin(R) combination arm. The incidence of increased bilirubin was similar on both arms. Changes noted on liver biopsies include: peliosis, nodular regenerative hyperplasia or sinusoidal alterations, perisinusoidal fibrosis and veno-occlusive lesions. Hepatic vascular disorders should be considered and, if appropriate, investigated in case of abnormal liver function test results or portal hypertension not explained by liver metastases -- Monitoring of white blood cell count with differential, hemoglobin, platelet count and blood chemistries (including ALT, AST, bilirubin and creatinine) is recommended before each Eloxatin(R) cycle -- The safety and effectiveness of Eloxatin(R) plus 5-FU/LV in patients with renal impairment have not been evaluated. Since the primary route of platinum elimination is renal, this combination should be used with caution in patients with preexisting renal impairment. Clearance of these products may be decreased by coadministration of potentially nephrotoxic compounds, although this has not been specifically studied -- The incidence of diarrhea, dehydration, hypokalemia, leukopenia, fatigue and syncope were higher in patients greater than or equal to 65 years old -- Extravasation may result in local pain and inflammation that may be severe and lead to complications, including necrosis. Injection site reaction, including redness, swelling and pain, has been reported -- There have been reports of prolonged prothrombin time and INR occasionally associated with hemorrhage in patients receiving Eloxatin(R) plus 5-FU/LV while on anticoagulants. Patients receiving Eloxatin(R) plus 5-FU/LV and requiring oral anticoagulant s may require closer monitoring -- The most common adverse reactions in patients with stage II or III colon cancer receiving adjuvant therapy were peripheral sensory neuropathy, neutropenia, thrombocytopenia, anemia, nausea, increase in transaminases and alkaline phosphatase, diarrhea, emesis, fatigue, and stomatitis. The most common adverse reactions in patients with advanced colorectal cancer were peripheral sensory neuropathy, fatigue, neutropenia, nausea, emesis, and diarrhea
For more information about Eloxatin(R) or for full prescribing information, including BOXED WARNING, visit http://www.eloxatin.com.
About Taxotere(R) Indications and Usage
Taxotere(R) is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy.
Taxotere(R) in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable node-positive breast cancer.
Non-Small Cell Lung Cancer (NSCLC)
Taxotere(R), as a single agent, is indicated for the treatment of patients with locally advanced or metastatic NSCLC after failure of prior platinum- based chemotherapy.
Taxotere(R) in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic NSCLC who have not previously received chemotherapy for this condition.
Taxotere(R) in combination with prednisone is indicated for the treatment of patients with androgen independent (hormone refractory) metastatic prostate cancer.
Taxotere(R) in combination with cisplatin and flourouracil is indicated for the treatment of patients with advanced gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for advanced disease.
Head and Neck Cancer
Taxotere(R) in combination with cisplatin and fluorouracil is indicated for the induction treatment of patients with inoperable locally advanced squamous cell carcinoma of the head and neck (SCCHN).
Important safety information
WARNING: Taxotere(R) treatment can cause serious, physically limiting, and potentially life-threatening side effects, such as infection, low blood-cell counts, allergic reaction and retention of excess fluid (edema).
Taxotere(R) in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic NSCLC who have not previously received chemotherapy for this condition.
Taxotere(R) should not be given to patients with low white-blood-cell counts, abnormal liver function, or a history of allergic reactions to Taxotere(R) or any of the ingredients in Taxotere(R).
Before each Taxotere(R) treatment, all patients treated with Taxotere(R) must receive another medicine called dexamethasone. This drug can help reduce the risk of fluid retention (edema) and allergic reactions.
Taxotere(R) should be administered only under the supervision of a qualified physician experienced in the use of anticancer treatments. Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are readily available.
Treatment-related acute myeloid leukemia (AML) has occurred in
patients given anthracyclines and/or cyclophosphamide, including
use with Taxotere(R) in adjuvant therapy for breast cancer. The
most common severe side effects are low white-blood-cell count,
anemia, fatigue, diarrhea, and mouth and throat irritation. Low
white-blood-cell count can lead to life-threatening infections. The
earliest sign of infection may be fever, so tell your doctor right
away if you have a fever. Other common side effects from
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