Two phase III studies in Central Retinal Vein Occlusion (CRVO) to begin in the second half of this year
Leverkusen, Germany and Tarrytown, NY, USA | April 30, 2009 | Bayer HealthCare AG and Regeneron Pharmaceuticals, Inc. today announced that the companies will extend their development program for VEGF Trap-Eye, an investigational new substance for the treatment of certain eye diseases, to include Central Retinal Vein Occlusion (CRVO). The companies plan to initiate a Phase III program evaluating the efficacy and safety of VEGF Trap-Eye in the treatment of this disease in the second half of this year. CRVO is caused by obstruction of the central retinal vein that leads to retinal injury and loss of vision. The retina can also become "ischemic" (starved for oxygen), resulting in the growth of new, inappropriate blood vessels that can cause further vision loss and more serious complications.
The Phase III program in CRVO will consist of two, multinational, one year clinical studies which have been reviewed with U.S. and European regulatory authorities. These studies will expand the companies’ global development collaboration for VEGF Trap-Eye, which already includes two ongoing Phase III studies in patients with the neovascular form of Age-related Macular Degeneration (wet AMD) and a Phase II study in patients with Diabetic Macular Edema (DME). Enrollment in the AMD and DME studies is expected to be completed later this year.
“Although CRVO is a leading cause of blindness, there is currently no treatment available worldwide that can be considered the standard of care, and there is no approved treatment to prevent the loss of vision or improve vision once it is lost,” said Dr. Kemal Malik, Head of Global Development and member of the Bayer HealthCare Executive Committee. “Since the underlying biology of CRVO is related to edema and the inappropriate growth of new blood vessels that are mediated by vascular endothelial growth factor, we are hopeful that VEGF Trap-Eye may help address this significant unmet medical need.”
About CRVO
Over 100,000 people in the United States and more than 66,000 people in key European countries are estimated to suffer from CRVO. CRVO is caused by obstruction of the central retinal vein that leads to a back up of blood and fluid in the retina. This causes retinal injury and loss of vision. The retina can also become "ischemic" (starved for oxygen), resulting in the growth of new, inappropriate blood vessels that can cause further vision loss and more serious complications. Release of VEGF contributes to increased vascular permeability in the eye and inappropriate new vessel growth. It is believed that anti-VEGF treatment may help decrease vascular permeability and edema and prevent the inappropriate growth of new blood vessels in the retina in patients with CRVO.
About the Phase III Program CRVO
In their Phase III CRVO program, Regeneron and Bayer HealthCare will conduct two identical multinational clinical studies: COPERNICUS (Controlled Phase III Evaluation of Repeated intravitreal administration of VEGF Trap-Eye In Central retinal vein occlusion: Utility and Safety) will be led by Regeneron and GALILEO (General Assessment Limiting Infiltration of Exudates in central retinal vein Occlusion with VEGF Trap-Eye) will be led by Bayer HealthCare. Enrollment will be initiated later in 2009.
Patients in both studies will receive 6 monthly injections of either VEGF Trap-Eye at a dose of 2 milligrams (mg) or sham control injections. The primary endpoint of both studies is improvement in visual acuity versus baseline after 6 months of treatment. At the end of the initial 6 months, all patients will be dosed on a PRN (as needed) basis for another 6 months. All patients will be eligible for rescue laser treatment.
About VEGF Trap-Eye
Vascular Endothelial Growth Factor (VEGF) is a naturally occurring protein in the body whose normal role is to trigger formation of new blood vessels (angiogenesis) to support the growth of the body’s tissues and organs. It has also been associated with the abnormal growth and fragility of new blood vessels in the eye and vascular permeability and edema. VEGF Trap-Eye is a fully human, soluble VEGF receptor fusion protein that binds all forms of VEGF-A along with the Placental Growth Factor (PlGF). Investigational VEGF Trap-Eye is a specific and highly potent blocker of VEGF-A and PlGF that has been demonstrated in preclinical models to bind these growth factors with greater affinity than their natural receptors.
Regeneron and Bayer HealthCare are collaborating on the global development of VEGF Trap-Eye for the treatment of wet AMD, DME, CRVO, and other eye diseases and disorders. Bayer HealthCare will market VEGF Trap-Eye outside the United States, where the companies will share equally in profits from any future sales of VEGF Trap-Eye. Regeneron maintains exclusive rights to VEGF Trap-Eye in the United States.
About Regeneron Pharmaceuticals
Regeneron is a fully integrated biopharmaceutical company that discovers, develops, and commercializes medicines for the treatment of serious medical conditions. In addition to ARCALYST® (rilonacept) Injection for Subcutaneous Use, its first commercialized product, Regeneron has therapeutic candidates in clinical trials for the potential treatment of cancer, eye diseases, inflammatory diseases, and pain and has preclinical programs in other diseases and disorders. Additional information about Regeneron and recent news releases are available on Regeneron’s web site at www.regeneron.com
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer HealthCare, a subsidiary of Bayer AG, is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Bayer Schering Pharma, Consumer Care and Medical Care divisions. Bayer HealthCare’s aim is to discover and manufacture products that will improve human and animal health worldwide. Find more information at www.bayerhealthcare.com.
Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company. Its research and business activities are focused on the following areas: Diagnostic Imaging, General Medicine, Specialty Medicine and Women’s Healthcare. With innovative products, Bayer Schering Pharma aims for leading positions in specialized markets worldwide. Using new ideas, Bayer Schering Pharma aims to make a contribution to medical progress and strives to improve the quality of life. Find more information at www.bayerscheringpharma.de.
SOURCE: Bayer HealthCare
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Two phase III studies in Central Retinal Vein Occlusion (CRVO) to begin in the second half of this year
Leverkusen, Germany and Tarrytown, NY, USA | April 30, 2009 | Bayer HealthCare AG and Regeneron Pharmaceuticals, Inc. today announced that the companies will extend their development program for VEGF Trap-Eye, an investigational new substance for the treatment of certain eye diseases, to include Central Retinal Vein Occlusion (CRVO). The companies plan to initiate a Phase III program evaluating the efficacy and safety of VEGF Trap-Eye in the treatment of this disease in the second half of this year. CRVO is caused by obstruction of the central retinal vein that leads to retinal injury and loss of vision. The retina can also become "ischemic" (starved for oxygen), resulting in the growth of new, inappropriate blood vessels that can cause further vision loss and more serious complications.
The Phase III program in CRVO will consist of two, multinational, one year clinical studies which have been reviewed with U.S. and European regulatory authorities. These studies will expand the companies’ global development collaboration for VEGF Trap-Eye, which already includes two ongoing Phase III studies in patients with the neovascular form of Age-related Macular Degeneration (wet AMD) and a Phase II study in patients with Diabetic Macular Edema (DME). Enrollment in the AMD and DME studies is expected to be completed later this year.
“Although CRVO is a leading cause of blindness, there is currently no treatment available worldwide that can be considered the standard of care, and there is no approved treatment to prevent the loss of vision or improve vision once it is lost,” said Dr. Kemal Malik, Head of Global Development and member of the Bayer HealthCare Executive Committee. “Since the underlying biology of CRVO is related to edema and the inappropriate growth of new blood vessels that are mediated by vascular endothelial growth factor, we are hopeful that VEGF Trap-Eye may help address this significant unmet medical need.”
About CRVO
Over 100,000 people in the United States and more than 66,000 people in key European countries are estimated to suffer from CRVO. CRVO is caused by obstruction of the central retinal vein that leads to a back up of blood and fluid in the retina. This causes retinal injury and loss of vision. The retina can also become "ischemic" (starved for oxygen), resulting in the growth of new, inappropriate blood vessels that can cause further vision loss and more serious complications. Release of VEGF contributes to increased vascular permeability in the eye and inappropriate new vessel growth. It is believed that anti-VEGF treatment may help decrease vascular permeability and edema and prevent the inappropriate growth of new blood vessels in the retina in patients with CRVO.
About the Phase III Program CRVO
In their Phase III CRVO program, Regeneron and Bayer HealthCare will conduct two identical multinational clinical studies: COPERNICUS (Controlled Phase III Evaluation of Repeated intravitreal administration of VEGF Trap-Eye In Central retinal vein occlusion: Utility and Safety) will be led by Regeneron and GALILEO (General Assessment Limiting Infiltration of Exudates in central retinal vein Occlusion with VEGF Trap-Eye) will be led by Bayer HealthCare. Enrollment will be initiated later in 2009.
Patients in both studies will receive 6 monthly injections of either VEGF Trap-Eye at a dose of 2 milligrams (mg) or sham control injections. The primary endpoint of both studies is improvement in visual acuity versus baseline after 6 months of treatment. At the end of the initial 6 months, all patients will be dosed on a PRN (as needed) basis for another 6 months. All patients will be eligible for rescue laser treatment.
About VEGF Trap-Eye
Vascular Endothelial Growth Factor (VEGF) is a naturally occurring protein in the body whose normal role is to trigger formation of new blood vessels (angiogenesis) to support the growth of the body’s tissues and organs. It has also been associated with the abnormal growth and fragility of new blood vessels in the eye and vascular permeability and edema. VEGF Trap-Eye is a fully human, soluble VEGF receptor fusion protein that binds all forms of VEGF-A along with the Placental Growth Factor (PlGF). Investigational VEGF Trap-Eye is a specific and highly potent blocker of VEGF-A and PlGF that has been demonstrated in preclinical models to bind these growth factors with greater affinity than their natural receptors.
Regeneron and Bayer HealthCare are collaborating on the global development of VEGF Trap-Eye for the treatment of wet AMD, DME, CRVO, and other eye diseases and disorders. Bayer HealthCare will market VEGF Trap-Eye outside the United States, where the companies will share equally in profits from any future sales of VEGF Trap-Eye. Regeneron maintains exclusive rights to VEGF Trap-Eye in the United States.
About Regeneron Pharmaceuticals
Regeneron is a fully integrated biopharmaceutical company that discovers, develops, and commercializes medicines for the treatment of serious medical conditions. In addition to ARCALYST® (rilonacept) Injection for Subcutaneous Use, its first commercialized product, Regeneron has therapeutic candidates in clinical trials for the potential treatment of cancer, eye diseases, inflammatory diseases, and pain and has preclinical programs in other diseases and disorders. Additional information about Regeneron and recent news releases are available on Regeneron’s web site at www.regeneron.com
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer HealthCare, a subsidiary of Bayer AG, is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Bayer Schering Pharma, Consumer Care and Medical Care divisions. Bayer HealthCare’s aim is to discover and manufacture products that will improve human and animal health worldwide. Find more information at www.bayerhealthcare.com.
Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company. Its research and business activities are focused on the following areas: Diagnostic Imaging, General Medicine, Specialty Medicine and Women’s Healthcare. With innovative products, Bayer Schering Pharma aims for leading positions in specialized markets worldwide. Using new ideas, Bayer Schering Pharma aims to make a contribution to medical progress and strives to improve the quality of life. Find more information at www.bayerscheringpharma.de.
SOURCE: Bayer HealthCare
Post Views: 50
