July 7, 2011
/PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the Phase 3 VENICE clinical trial evaluating the investigational agent ZALTRAP™ (aflibercept) in the first-line treatment of patients with androgen-independent (hormone-refractory) metastatic prostate cancer will continue to completion as planned, with no modifications due to efficacy or to safety concerns. This decision is based on the recommendation of an Independent Data Monitoring Committee (IDMC) following a planned interim analysis. Regeneron and Sanofi are collaborating in the development of ZALTRAP in oncology. Both Regeneron and Sanofi management and staff remain blinded to the interim study results.
"We look forward to the final results of this trial next year in the hope of providing a new therapy for patients with metastatic prostate cancer," said
George D. Yancopoulos
, M.D., Ph.D., Chief Scientific Officer of Regeneron and President of Regeneron Research Laboratories.
About the VENICE Study
The main objective of the multinational
study (Aflibercept in Combination with Docetaxel in Metastatic Androgen Independent Prostate Cancer)(1) is to evaluate the efficacy and safety of ZALTRAP as a first-line treatment in combination with docetaxel and prednisone in 1,200 patients with hormone-refractory metastatic prostate cancer. The primary endpoint is improvement in overall survival. Secondary endpoints include Prostate Specific Antigen (PSA) measurement, pain measurement, progression-free survival and safety. The trial is fully enrolled with 1,224 randomized patients, and final results are anticipated in 2012.
About ZALTRAP and the Clinical Development Program
ZALTRAP™ (aflibercept), also known as VEGF Trap, is an investigational broad-spectrum angiogenesis inhibitor with a unique mechanism of action. This fully-human 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. ZALTRAP has been shown to bind VEGF-A, VEGF-B and PlGF with higher affinity than their native receptors.