To: Miljenko Zuanic who wrote (600 ) 11/29/2001 12:50:38 AM From: Miljenko Zuanic Read Replies (1) | Respond to of 3559 Wednesday November 28, 7:04 am Eastern Time Press Release SOURCE: Regeneron Pharmaceuticals, Inc. Regeneron Initiates Clinical Trial of VEGF Trap in Cancer Second Product Candidate from Proprietary Trap Platform to Enter Clinical Trials TARRYTOWN, N.Y.--(BW HealthWire)--Nov. 28, 2001--Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN - news) announced today at the Robertson Stephens Medical Conference that it has initiated a Phase I clinical trial that is designed to assess the safety and tolerability of the Company's VEGF Trap, a potent angiogenesis inhibitor, in patients with solid tumor malignancies and patients with non-Hodgkin's lymphoma. Tumors depend on the formation of new blood vessels - a process termed ``angiogenesis'' - to support their growth. Blocking tumor-associated angiogenesis can prevent tumor growth, and the most widely validated target for such angiogenesis blockade is Vascular Endothelial Growth Factor (VEGF). The Phase I trial is an open-label study in patients with advanced tumors and will evaluate the VEGF Trap in increasing dose levels. The study is being conducted at a clinical site in New York City. ``The VEGF Trap clinical trial represents an important first milestone in our efforts to commercialize our extensive research in angiogenesis. said George Yancopoulos, M.D., Ph.D., Executive Vice President and Chief Scientific Officer of Regeneron. We believe that there may be several opportunities to extend this research to other healthcare problems in which the regulation of blood vessel growth and function may play a key role.'' ``In early stage clinical trials, Genentech, Inc. has conducted pioneering work indicating that the blockage of VEGF may be an important new approach to cancer treatment,'' noted Leonard S. Schleifer, M.D., Ph.D., Regeneron's President and Chief Executive Officer. ``Our preclinical studies suggest that our VEGF Trap has the potential to be a very potent blocker of VEGF. The Role of VEGF in the Growth of Solid Tumors Vascular Endothelial Growth Factor (VEGF) is a naturally occurring protein in the body whose normal role is to trigger angiogenesis, the formation of new blood vessels to support the growth of the body's tissues and organs. In early stages of life, embryos and young animals undergo large amounts of angiogenesis to support their rapid growth. In adults with fully developed vascular systems, the need for on-going angiogenesis is very limited. A notable exception occurs in the case of growing tumors, which induce sprouting of new blood vessels to support their growth. Blocking tumor-associated angiogenesis has been shown to prevent tumor growth in a variety of animal models, with the best results achieved using approaches that block VEGF. Recently, indications of efficacy were reported by another company in human clinical trials of a VEGF-blocking antibody in renal cell carcinoma. The VEGF Trap: How it May Prevent Solid Tumor Growth Regeneron has developed a potent VEGF blocker termed a VEGF Trap, based on its proprietary Trap technology platform. This technology has also produced an interleukin-1 blocker (IL-1 Trap) for rheumatoid arthritis that is currently in clinical trials and an interleukin-4/interleukin-13 dual blocker (IL-4/IL-13 Trap) for allergy and asthma that is expected to enter clinical trials in 2002. The VEGF Trap is a fusion protein that contains portions of the extracellular domains of two different VEGF receptors. These receptors occur naturally on blood vessels. By combining key portions of the receptors that bind VEGF, the VEGF Trap blocks VEGF activity and prevents the formation of new blood vessels needed to sustain growth in cancerous tumors. In laboratory experiments in many different tumor types, the Company has shown that the VEGF Trap has effectively blocked angiogenesis, leaving tumors with few or no blood vessels feeding them. The VEGF Trap may also have applications outside of cancer in areas where pathologic vessel growth can cause problems, such as diabetic retinopathy, psoriasis, and corneal neovascularization associated with transplants, infection, or trauma.