No data on starting dose? How many center will participate?
Hope it will not take as long as was for PI sc. One year extension sound good.
Aventis and Regeneron Start Clinical Development for VEGF Trap as a Potential Treatment for Eye Diseases
Tuesday March 9, 1:00 am ET
STRASBOURG, France & TARRYTOWN, N.Y.--(BUSINESS WIRE)--March 9, 2004--
Initial Phase I Study Will Evaluate Safety and Tolerability of
VEGF Trap in Patients with Age Related Macular Degeneration (AMD)
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Aventis and Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN - News) announced today the initiation of a clinical development program for the VEGF Trap. The initial Phase I clinical trial is being conducted in patients with the neovascular or "wet" form of Age Related Macular Degeneration (wet AMD), a degenerative condition that is a major cause of severe vision impairment and blindness in adults over 55.
Wet AMD occurs when new vessels form to improve the blood supply to retinal tissue, specifically beneath the macula (the central retina). The new vessels are easily damaged and sometimes rupture, causing bleeding and injury to the surrounding tissue. Although wet AMD only occurs in about 10 percent of all AMD cases, it accounts for approximately 90% of AMD-related blindness.
The Phase I trial is a randomized, placebo-controlled, dose-escalating study designed to assess the safety and tolerability of VEGF Trap in wet AMD and obtain a preliminary assessment of the potential effect of the VEGF Trap on visual acuity. Based on safety and tolerability measurements in the initial treatment period, patients may be allowed to continue treatment with VEGF Trap in a one year, open-label safety extension phase that will also examine the durability of effects.
Patients in the study will receive VEGF Trap via intravenous infusions. In preclinical studies conducted in the laboratory of Dr. Peter Campochiaro, Professor of Ophthalmology at The Johns Hopkins University School of Medicine, the VEGF Trap inhibited the growth of new blood vessels when given intravenously, as well as when administered directly into the eye.
"We believe that intravenous administration of the VEGF Trap has the potential to provide distinct clinical advantages, including increased patient comfort and acceptance and less risk of ocular infection due to direct penetration of the eye by an injection," said Jesse M. Cedarbaum, MD, Vice President of Clinical Affairs at Regeneron.
"Initiation of this trial is a significant step forward in exploring the potential benefit the VEGF Trap can provide to patients suffering from ocular diseases," states Bruce Seeley, Head of Oncology New Products and Licensing at Aventis. "The VEGF Trap's unique mechanism of action makes it potentially useful in multiple diseases that are affected by abnormal blood vessel growth or integrity."
Regeneron is nearing completion of its initial Phase I clinical trial of the VEGF Trap in patients with solid tumor malignancies and patients with non-Hodgkin's lymphoma.
The Role of VEGF in Age Related Macular Degeneration
Vascular Endothelial Growth Factor (VEGF) is a naturally occurring protein in the body that has been associated with the abnormal growth and fragility of new blood vessels, important factors in the development of wet AMD. The VEGF Trap has been shown in preclinical studies to block the action of VEGF, thereby blocking the abnormal growth of blood vessels.
Growth factors, such as VEGF, and cytokines help regulate immune, inflammatory and growth responses. In excess, growth factors and cytokines can be harmful and have been linked to a variety of diseases. Blocking growth factors and cytokines is a proven therapeutic approach with a number of medicines already approved for marketing by the U.S. Food and Drug Administration (FDA). In a number of publications, Regeneron has reported a breakthrough in understanding how receptors work for an entire class of growth factors and cytokines in the human body (e.g., Davis et al., Science 260:1805 (1993); Stahl et al., Science 263:92 (1994)). Based on these findings, Regeneron developed the VEGF Trap, a blocker of the growth factor VEGF. |
