Sanofi-aventis and Regeneron Pharmaceuticals announced that the Phase 3 VELOUR clinical trial of aflibercept (VEGF Trap) in patients with metastatic colorectal cancer (mCRC) will continue to completion as planned, with no modifications due to efficacy or safety concerns
PARIS, FRANCE and TARRYTOWN, NY, USA | September 8, 2010 | Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) and Regeneron Pharmaceuticals, Inc. (Nasdaq:REGN – News) announced today that the Phase 3 VELOUR clinical trial of aflibercept (VEGF Trap) in patients with metastatic colorectal cancer (mCRC) will continue to completion as planned, with no modifications due to efficacy or safety concerns. This decision is based on the recommendation of an Independent Data Monitoring Committee (IDMC) following a planned interim analysis. Both sanofi-aventis and Regeneron management and staff remain blinded to the interim study results.
"We look forward to the final results of the trial, which are expected in the second half of 2011 with belief that the combination of aflibercept and FOLFIRI has the potential to benefit patients with this difficult-to-treat disease," said Tal Zaks, Head of Development, Global Oncology Division, sanofi-aventis.
About the VELOUR Study
The main objective of the VELOUR (Aflibercept Versus Placebo in Combination with Irinotecan and 5-FU [FOLFIRI] in the Treatment of Patients with Metastatic Colorectal Cancer after Failure of an Oxaliplatin Based Regimen) study is to evaluate the safety and effectiveness of aflibercept as a second-line treatment in combination with folinic acid (leucovorin), 5-fluorouracil, and irinotecan (FOLFIRI) in 1,226 patients with mCRC who previously had been treated with an oxaliplatin-based regimen. The primary endpoint is improvement in overall survival. Secondary endpoints include progression-free survival, response to treatment, and safety.
About the Aflibercept Clinical Development Program
Sanofi-aventis Oncology and Regeneron are collaborating on a broad oncology development program combining aflibercept (VEGF Trap) with common chemotherapy regimens in several types of cancer. In addition to VELOUR, the program includes two Phase 3 trials and one Phase 2 trial, all of which are fully enrolled:
* VITAL study: 2nd-line treatment for metastatic non-small cell lung cancer in combination with docetaxel (Phase 3). Complete results are anticipated in the first half of 2011.
* VENICE study: 1st-line treatment for hormone-refractory metastatic prostate cancer (mHRPC) in combination with docetaxel and prednisone (Phase 3). An interim analysis is expected to be conducted by an IDMC in mid-2011, with complete results anticipated in 2012.
* AFFIRM study: 1st-line treatment in mCRC in combination with folinic acid (leucovorin), 5-fluorouracil, and oxaliplatin (FOLFOX) (Phase 2). Results are anticipated in 2H 2011.
About Aflibercept
Aflibercept (VEGF Trap) is an anti-angiogenesis inhibitor with a unique mechanism of action. This fusion protein binds all forms of Vascular Endothelial Growth Factor-A (VEGF-A), as well as VEGF-B and placental growth factor (PIGF), additional angiogenic growth factors that appear to play a role in tumor angiogenesis and inflammation. Aflibercept has been shown to bind VEGF-A, VEGF-B, and PlGF with higher affinity than their natural receptors.
About Colorectal Cancer
Worldwide, colorectal cancer is the third most common cancer in men and the second in women; accounting for about 8% of all cancer deaths, making it the fourth most common cause of death from cancer. Colorectal cancer disproportionately affects people over age 65. FOLFIRI (5-fluorouracil, leucovorin, and irinotecan) is considered a standard backbone of second-line treatment in patients with advanced metastatic colorectal cancer.
About sanofi-aventis Oncology
Sanofi-aventis Oncology is targeting cancer on all 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 cancer develops, grows and spreads, as well as identifying the right science early in the discovery process, the company employs innovative approaches to bring the right medicines to the right patients. There are currently more than 10 compounds in development across a broad scientific platform, including cytotoxic, antimitotic, anti-angiogenic agents, antivascular agents, monoclonal antibodies and cancer vaccines, as well as supportive care therapies. Four of these compounds are now being investigated in Phase 3 clinical studies aimed at multiple solid and hematologic tumors.
About sanofi-aventis
Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE:SNY – News).
About Regeneron Pharmaceuticals, Inc.
Regeneron is a fully integrated biopharmaceutical company that discovers, develops, and commercializes medicines for the treatment of serious medical conditions. In addition to ARCALYST® (rilonacept) Injection for Subcutaneous Use, its first commercialized product, Regeneron has therapeutic candidates in Phase 3 clinical trials for the potential treatment of gout, diseases of the eye (wet age-related macular degeneration and central retinal vein occlusion), and certain cancers. Additional therapeutic candidates developed from proprietary Regeneron technologies for creating fully human monoclonal antibodies are in earlier stage development programs in rheumatoid arthritis and other inflammatory conditions, pain, cholesterol reduction, allergic and immune conditions, and cancer. Additional information about Regeneron and recent news releases are available on Regeneron’s web site at www.regeneron.com.
SOURCE: Regeneron Pharmaceuticals, Inc.
Post Views: 110
Sanofi-aventis and Regeneron Pharmaceuticals announced that the Phase 3 VELOUR clinical trial of aflibercept (VEGF Trap) in patients with metastatic colorectal cancer (mCRC) will continue to completion as planned, with no modifications due to efficacy or safety concerns
PARIS, FRANCE and TARRYTOWN, NY, USA | September 8, 2010 | Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) and Regeneron Pharmaceuticals, Inc. (Nasdaq:REGN – News) announced today that the Phase 3 VELOUR clinical trial of aflibercept (VEGF Trap) in patients with metastatic colorectal cancer (mCRC) will continue to completion as planned, with no modifications due to efficacy or safety concerns. This decision is based on the recommendation of an Independent Data Monitoring Committee (IDMC) following a planned interim analysis. Both sanofi-aventis and Regeneron management and staff remain blinded to the interim study results.
"We look forward to the final results of the trial, which are expected in the second half of 2011 with belief that the combination of aflibercept and FOLFIRI has the potential to benefit patients with this difficult-to-treat disease," said Tal Zaks, Head of Development, Global Oncology Division, sanofi-aventis.
About the VELOUR Study
The main objective of the VELOUR (Aflibercept Versus Placebo in Combination with Irinotecan and 5-FU [FOLFIRI] in the Treatment of Patients with Metastatic Colorectal Cancer after Failure of an Oxaliplatin Based Regimen) study is to evaluate the safety and effectiveness of aflibercept as a second-line treatment in combination with folinic acid (leucovorin), 5-fluorouracil, and irinotecan (FOLFIRI) in 1,226 patients with mCRC who previously had been treated with an oxaliplatin-based regimen. The primary endpoint is improvement in overall survival. Secondary endpoints include progression-free survival, response to treatment, and safety.
About the Aflibercept Clinical Development Program
Sanofi-aventis Oncology and Regeneron are collaborating on a broad oncology development program combining aflibercept (VEGF Trap) with common chemotherapy regimens in several types of cancer. In addition to VELOUR, the program includes two Phase 3 trials and one Phase 2 trial, all of which are fully enrolled:
* VITAL study: 2nd-line treatment for metastatic non-small cell lung cancer in combination with docetaxel (Phase 3). Complete results are anticipated in the first half of 2011.
* VENICE study: 1st-line treatment for hormone-refractory metastatic prostate cancer (mHRPC) in combination with docetaxel and prednisone (Phase 3). An interim analysis is expected to be conducted by an IDMC in mid-2011, with complete results anticipated in 2012.
* AFFIRM study: 1st-line treatment in mCRC in combination with folinic acid (leucovorin), 5-fluorouracil, and oxaliplatin (FOLFOX) (Phase 2). Results are anticipated in 2H 2011.
About Aflibercept
Aflibercept (VEGF Trap) is an anti-angiogenesis inhibitor with a unique mechanism of action. This fusion protein binds all forms of Vascular Endothelial Growth Factor-A (VEGF-A), as well as VEGF-B and placental growth factor (PIGF), additional angiogenic growth factors that appear to play a role in tumor angiogenesis and inflammation. Aflibercept has been shown to bind VEGF-A, VEGF-B, and PlGF with higher affinity than their natural receptors.
About Colorectal Cancer
Worldwide, colorectal cancer is the third most common cancer in men and the second in women; accounting for about 8% of all cancer deaths, making it the fourth most common cause of death from cancer. Colorectal cancer disproportionately affects people over age 65. FOLFIRI (5-fluorouracil, leucovorin, and irinotecan) is considered a standard backbone of second-line treatment in patients with advanced metastatic colorectal cancer.
About sanofi-aventis Oncology
Sanofi-aventis Oncology is targeting cancer on all 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 cancer develops, grows and spreads, as well as identifying the right science early in the discovery process, the company employs innovative approaches to bring the right medicines to the right patients. There are currently more than 10 compounds in development across a broad scientific platform, including cytotoxic, antimitotic, anti-angiogenic agents, antivascular agents, monoclonal antibodies and cancer vaccines, as well as supportive care therapies. Four of these compounds are now being investigated in Phase 3 clinical studies aimed at multiple solid and hematologic tumors.
About sanofi-aventis
Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE:SNY – News).
About Regeneron Pharmaceuticals, Inc.
Regeneron is a fully integrated biopharmaceutical company that discovers, develops, and commercializes medicines for the treatment of serious medical conditions. In addition to ARCALYST® (rilonacept) Injection for Subcutaneous Use, its first commercialized product, Regeneron has therapeutic candidates in Phase 3 clinical trials for the potential treatment of gout, diseases of the eye (wet age-related macular degeneration and central retinal vein occlusion), and certain cancers. Additional therapeutic candidates developed from proprietary Regeneron technologies for creating fully human monoclonal antibodies are in earlier stage development programs in rheumatoid arthritis and other inflammatory conditions, pain, cholesterol reduction, allergic and immune conditions, and cancer. Additional information about Regeneron and recent news releases are available on Regeneron’s web site at www.regeneron.com.
SOURCE: Regeneron Pharmaceuticals, Inc.
Post Views: 110
