Regeneron, sanofi-aventis start phase 2 trial on VEGF Trap

By Ted A. Knutson

Washington, Jan. 31 - Regeneron Pharmaceuticals, Inc. said Tuesday that it and sanofi-aventis have begun a phase 2, multicenter, open-label, single-arm, two-stage study of the efficacy and safety of the Vascular Endothelial Growth Factor (VEGF) Trap administered intravenously every two weeks in patients with platinum- and erlotinib-resistant, locally advanced or metastatic non-small lung adenocarcinoma.

The primary purpose of the trial is to determine the overall objective response rate of the VEGF Trap (4.0 milligram/kilogram) delivered intravenously every two weeks in platinum- and erlotinib-resistant patients with locally advanced or metastatic non-small cell lung adenocarcinoma.

The secondary purposes of the trial are to assess the safety of the VEGF Trap and the duration of response, progression-free survival, and overall survival in this patient population.

Paris-based sanofi-aventis is developing products in major therapeutic areas including cardiovascular, thrombosis, oncology, metabolic diseases and vaccines.

Regeneron is a Tarrytown, N.Y.-based drug firm.

The announcement was made in an 8-K filing with the Securities and Exchange Commission.

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