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Regeneron Initiates VEGF Trap Intravitreal Clinical Development Program As Potental Treatment for Eye Diseases

Posted on: Tuesday, 5 July 2005, 09:01 CDT

Initial Clinical Trial Will Evaluate VEGF Trap Given by Intravitreal (or Direct) Injection to the Eye in Patients with Age Related Macular Degeneration

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), 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 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 (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 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 using intravenous delivery. These results were presented at the 2005 Association for Research in Vision and Ophthalmology (ARVO) 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 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. Regeneron has therapeutic candidates in clinical trials for the potential treatment of cancer and eye diseases, rheumatoid arthritis 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 for the year ended December 31, 2004 and the Form 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

Source: Business Wire

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