Phase 3 Trial of ZALTRAP™ (aflibercept) in Advanced Prostate Cancer to Continue as Planned at Recommendation of Independent Data Monitoring Committee
"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
About the VENICE Study
The main objective of the multinational
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.
Sanofi Oncology and Regeneron are collaborating on an oncology development program, combining the investigational agent ZALTRAP™ (aflibercept) with common chemotherapy regimens in the treatment of patients with advanced cancers. In addition to
- VELOUR study (Phase 3): second-line treatment in combination with the FOLFIRI regimen (irinotecan-5-fluorouracil-leucovorin) in patients with metastatic colorectal cancer (mCRC) previously treated with an oxaliplatin-based regimen. Positive results demonstrating significantly improved survival with ZALTRAP were presented
June 25during the ESMO World Congress on Gastrointestinal Cancer; the associated abstract (#0-0024) was published in the June 2011supplement to Annals of Oncology.
- AFFIRM study (Phase 2): first-line treatment in mCRC in combination with folinic acid (leucovorin), 5-fluorouracil, and oxaliplatin (FOLFOX). Results are anticipated in the second half of 2011.
About Prostate Cancer
Worldwide, prostate cancer ranks second in cancer incidence, with approximately 900,000 new cases annually, and sixth in cancer mortality in men.(2) Latest figures show that an estimated 324,000 new cases of prostate cancer appear in the
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, central retinal vein occlusion, and diabetic macular edema), 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.
Forward Looking Statements
This news release includes forward-looking statements that involve risks and uncertainties relating to future events and the future financial performance of Regeneron, and actual events or results may differ materially from these forward-looking statements. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of Regeneron's product candidates and research and clinical programs now underway or planned, the likelihood and timing of possible regulatory approval and commercial launch of Regeneron's late-stage product candidates, determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron's ability to continue to develop or commercialize Regeneron's product and drug candidates, competing drugs that may be superior to Regeneron's product
and drug candidates, uncertainty of market acceptance of Regeneron's product and drug candidates, unanticipated expenses, the availability and cost of capital, the costs of developing, producing, and selling products, the potential for any license or collaboration agreement, including Regeneron's agreements with the
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(1) Aflibercept in combination with docetaxel in metastatic androgen independent prostate cancer (
(5) Tannok IF,
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