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Regeneron Pharmaceuticals Inc. ( REGN - Analyst Report ) received some good news when an Independent Data Monitoring Committee (IDMC) recommended the continuation of a late-stage study (VENICE) which is evaluating its cancer therapy Zaltrap (aflibercept) without any modifications.
The study is evaluating the candidate (in conjunction with docetaxel and prednisone) as a first-line therapy in patients suffering from androgen-independent (hormone-refractory) metastatic prostate cancer. The committee arrived at the decision after conducting an interim analysis of the data from the VENICE study. Regeneron is co-developing Zaltrap with Sanofi-Aventis ( SNY - Analyst Report ) .
Final results from the multicenter study, whose primary goal is to increase overall survival following Zaltrap treatment, are expected in 2012. The secondary objective of the study includes measurement of prostate specific antigen and pain coupled with progression-free survival and safety. Progression free survival indicates survival without the worsening of the disease.
If Zaltrap is successfully developed and commercialized, then the top line at Regeneron would be significantly boosted since the market for prostate cancer represents a significantopportunity.
Apart from the VENICE study, Zaltrap is also being evaluated in a phase II study (AFFIRM) as a first-line therapy in patients suffering from metastatic colorectal cancer. The AFFIRM study is evaluating Zaltrap in combination with Folfox (leucovorin, 5-fluorouracil and oxaliplatin). Results from the study are expected in the second half of 2011.
Moreover, Zaltrap was also being evaluated as a combination therapy in a late-stage, multinational study (VELOUR). The study evaluated Zaltrap as a second-line therapy in previously treated patients suffering from metastatic colorectal cancer. Positive results from the study were presented in June 2011.
Currently, we have a Neutral stance on Regeneron in the long run. The company carries a Zacks #3 Rank (Hold rating) in the short run.
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