Regeneron Initiates VEGF Trap Intravitreal Clinical Development Program as Potental Treatment for Eye Diseases.TARRYTOWN, N.Y. -- Initial Clinical Trial Will Evaluate VEGF VEGF vascular endothelial growth factor. Trap Given by Intravitreal (or Direct) Injection to the Eye in Patients with Age Related Macular Degeneration macular degeneration, eye disorder causing loss of central vision. The affected area, the macula, lies at the back of the retina and is the part that produces the sharpest vision. Regeneron Pharmaceuticals, Inc. (Nasdaq:REGN) announced today the initiation of a clinical program evaluating the VEGF Trap in certain eye diseases utilizing intravitreal (or direct) injections to the eye. The clinical trial is being conducted in patients with the neovascular or "wet" form of Age Related Macular Degeneration (wet AMD (Advanced Micro Devices, Inc., Sunnyvale, CA, www.amd.com) A major manufacturer of semiconductor devices including x86-compatible CPUs, embedded processors, flash memories, programmable logic devices and networking chips. ), a degenerative condition that is a major cause of severe vision impairment and blindness in adults over 55. "Blocking VEGF is a validated approach in treating wet AMD, and the VEGF Trap blocks all forms of VEGF-A with extremely high affinity," said Jesse M. Cedarbaum, MD, Vice President of Clinical Affairs at Regeneron. "This trial is another significant step forward in further exploring the potential benefit the VEGF Trap can provide to patients suffering from wet AMD and other eye diseases." The Phase 1 trial is a dose-escalating study designed to assess the safety and tolerability of VEGF Trap in patients with wet AMD. In the initial part of the trial, patients will receive a single dose of the VEGF Trap delivered by intravitreal injection into the eye, after which they will be evaluated for three months to measure the durability of effects and provide guidance for dosing regimens to be used in future trials. Wet AMD occurs when new blood vessels Blood vessels Tubular channels for blood transport, of which there are three principal types: arteries, capillaries, and veins. Only the larger arteries and veins in the body bear distinct names. form to improve the blood supply to retinal tissue, specifically beneath the macula (the central retina). The new vessels are leaky, easily damaged and sometimes rupture, causing swelling, 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 percent of AMD-related blindness. The VEGF Trap and Eye Diseases Vascular Endothelial Growth Factor Vascular endothelial growth factor (VEGF) is an important signaling protein involved in both vasculogenesis (the de novo formation of the embryonic circulatory system) and angiogenesis (the growth of blood vessels from pre-existing vasculature). (VEGF) is a naturally occurring protein in the body that has been associated with the abnormal growth, leakiness, and fragility of new blood vessels, important factors in the development of wet AMD. The VEGF Trap has been shown in preclinical studies preclinical studies, n.pl a term used to describe research done before a clinical study. May be laboratory or epidemiologic research. to block the action of VEGF, thereby blocking the abnormal growth of blood vessels. Researchers reported in May 2005 that the VEGF Trap had successfully met its pre-specified efficacy endpoint in patients with advanced wet AMD in its initial phase 1 clinical trial phase 1 clinical trial Phase 1 study. See Phase study. using intravenous delivery. These results were presented at the 2005 Association for Research in Vision and Ophthalmology (ARVO ARVO Association for Research in Vision and Ophthalmology. ) annual meeting. This study, which evaluated the safety and tolerability of the VEGF Trap when delivered by intravenous injections, showed a statistically significant decrease in excess retinal thickness, which increased in both magnitude and duration with higher doses. Growth factors, such as VEGF, and cytokines Cytokines Chemicals made by the cells that act on other cells to stimulate or inhibit their function. Cytokines that stimulate growth are called "growth factors. 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. About Regeneron Regeneron is a biopharmaceutical company that discovers, develops, and intends to commercialize therapeutic medicines for the treatment of serious medical conditions See carpal tunnel syndrome, computer vision syndrome, dry eyes and deep vein thrombosis. . Regeneron has therapeutic candidates in clinical trials for the potential treatment of cancer and eye diseases, rheumatoid arthritis rheumatoid arthritis Chronic, progressive autoimmune disease causing connective-tissue inflammation, mostly in synovial joints. It can occur at any age, is more common in women, and has an unpredictable course. and other inflammatory conditions, and asthma, and has preclinical programs in other diseases and disorders. Regeneron corporate headquarters are in Tarrytown, NY. For more information, please visit www.regn.com This news release discusses historical information and includes forward-looking statements about Regeneron and its products, programs, finances, and business, all of which involve a number of risks and uncertainties, such as risks associated with preclinical and clinical development of drugs and biologics, determinations by regulatory and administrative governmental authorities, competitive factors, technological developments, the availability and cost of capital, the costs of developing, producing, and selling products, the potential for any collaboration agreement to be canceled or to terminate without any product success, and other material risks. A more complete description of these risks can be found in Regeneron's filings with the United States Securities and Exchange Commission, including its Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. for the year ended December 31, 2004 and the Form 10-Q Form 10-Q See 10-Q. for the quarter ended March 31, 2005. Regeneron does not undertake any obligation to update publicly any forward-looking statement, whether as a result of new information, future events, or otherwise unless required by law. Additional information about Regeneron and recent news releases are available on Regeneron's Worldwide Web Home Page at www.regeneron.com |
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