Friday, September 25, 2009
Advanced Cell Completing Pre-Clinical Activities in Preparation for IND Filing
WORCESTER, Mass.,
Advanced Cell Technology, Inc. (Advanced Cell, ACT) (OTC: ACTC) provided an update on pre-clinical activities in preparation of its first IND filing with the Food and Drug Administration for its retinal pigment epithelium (RPE) cell program for the treatment of various eye diseases. In the next few weeks, the Company will be completing the preclinical work necessary for filing the IND. To date, no adverse events have occurred in testing. The results will be part of the submission which Advanced Cell expects to submit to the FDA prior to the end of the year.
"We are very pleased with the long-term safety and efficacy data," said Dr. Robert Lanza, ACT's Chief Scientific Officer. "We have carried out pre-clinical studies using these cells in multiple animal models, and to-date have not seen any teratoma formation or untoward pathological reactions. We are optimistic that human embryonic stem cells (hESCs) will serve as a potentially safe and inexhaustible source of RPE for the treatment of a range of macular degenerative diseases."
"We are pleased with the progress we have made in preparation for the FDA submission," said William M. Caldwell IV, Advanced Cell's Chairman and CEO. "In the retina, compromised RPE function can lead to deteriorated vision and photoreceptor loss in both age-related macular degeneration and other forms of degenerative eye disease. We look forward to further studying the role that our RPE cells can play in providing a potential solution to this problem."
For more information go to www.maculardegenerationassociation.org
Advanced Cell Technology, Inc. (Advanced Cell, ACT) (OTC: ACTC) provided an update on pre-clinical activities in preparation of its first IND filing with the Food and Drug Administration for its retinal pigment epithelium (RPE) cell program for the treatment of various eye diseases. In the next few weeks, the Company will be completing the preclinical work necessary for filing the IND. To date, no adverse events have occurred in testing. The results will be part of the submission which Advanced Cell expects to submit to the FDA prior to the end of the year.
"We are very pleased with the long-term safety and efficacy data," said Dr. Robert Lanza, ACT's Chief Scientific Officer. "We have carried out pre-clinical studies using these cells in multiple animal models, and to-date have not seen any teratoma formation or untoward pathological reactions. We are optimistic that human embryonic stem cells (hESCs) will serve as a potentially safe and inexhaustible source of RPE for the treatment of a range of macular degenerative diseases."
"We are pleased with the progress we have made in preparation for the FDA submission," said William M. Caldwell IV, Advanced Cell's Chairman and CEO. "In the retina, compromised RPE function can lead to deteriorated vision and photoreceptor loss in both age-related macular degeneration and other forms of degenerative eye disease. We look forward to further studying the role that our RPE cells can play in providing a potential solution to this problem."
For more information go to www.maculardegenerationassociation.org
Friday, September 18, 2009
Patient enrollment for Phase 3 clinical trials of VEGF Trap-Eye completed
Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) today announced the completion of patient enrollment in two randomized, double-masked, Phase 3 clinical trials evaluating VEGF Trap-Eye in the treatment of the neovascular form of age-related macular degeneration (wet AMD). In each study of the VIEW (VEGF Trap-Eye: Investigation of Efficacy and Safety in Wet AMD) program, VEGF Trap-Eye is being evaluated for its effect on maintaining and improving vision when dosed as an intravitreal injection on a schedule of 0.5 milligram (mg) every four weeks, 2.0 mg every four weeks, or 2.0 mg every eight weeks (following three monthly doses), as compared with intravitreal ranibizumab (Lucentis((R)), a registered trademark of Genentech, Inc.) administered 0.5 mg every four weeks during the first year of the studies. As-needed (PRN) dosing with both agents is being evaluated during the second year of each study. These studies are part of the global development program for VEGF Trap-Eye being conducted by Regeneron and Bayer HealthCare AG. Each study has enrolled in excess of the targeted 1,200 patient goal. One-year primary endpoint data from both studies are expected in the fourth quarter of 2010.
VEGF Trap-Eye, an investigational drug, is being developed by Regeneron and Bayer HealthCare AG for the potential treatment of eye diseases, including wet AMD, diabetic macular edema (DME), and Central Retinal Vein Occlusion (CRVO). Regeneron maintains exclusive rights to VEGF Trap-Eye in the United States. Bayer HealthCare has exclusive rights to market VEGF Trap-Eye outside the United States, where the companies will share equally in profits from any future sales of VEGF Trap-Eye.
"Even with recent advances in the treatment of wet AMD, vision is not improved or stabilized in all patients despite monthly office visits and examinations that are inconvenient for these often elderly patients," said George D. Yancopoulos, M.D., Ph.D., President of Regeneron Research Laboratories. "This Phase 3 program is exploring various doses and dosing schedules with our novel anti-VEGF investigational agent to evaluate whether further improvements in vision and/or longer dosing intervals than monthly administration are possible."
For more information go to www.maculardegenerationassociation.org
VEGF Trap-Eye, an investigational drug, is being developed by Regeneron and Bayer HealthCare AG for the potential treatment of eye diseases, including wet AMD, diabetic macular edema (DME), and Central Retinal Vein Occlusion (CRVO). Regeneron maintains exclusive rights to VEGF Trap-Eye in the United States. Bayer HealthCare has exclusive rights to market VEGF Trap-Eye outside the United States, where the companies will share equally in profits from any future sales of VEGF Trap-Eye.
"Even with recent advances in the treatment of wet AMD, vision is not improved or stabilized in all patients despite monthly office visits and examinations that are inconvenient for these often elderly patients," said George D. Yancopoulos, M.D., Ph.D., President of Regeneron Research Laboratories. "This Phase 3 program is exploring various doses and dosing schedules with our novel anti-VEGF investigational agent to evaluate whether further improvements in vision and/or longer dosing intervals than monthly administration are possible."
For more information go to www.maculardegenerationassociation.org
Wednesday, September 9, 2009
Advice for Seniors with Vision Loss
U.S.News & World Report
By Philip Moeller
Personal experience with macular degeneration.
I have macular degeneration (MD) in both eyes. The Amsler grid is used to determine if you have MD. When I look at the grid with just my right eye all of the lines of the grid seem straight and clear. With my left eye the lines are wavy and distorted. My ophthalmologist diagnosed macular degeneration and sent me to a retina specialist. My mother and both of her siblings had MD, so I was genetically predisposed to get it. The retina specialist took pictures of my macula, the central part of the retina that provides for sharp, clear vision. The pictures showed I had “dry” MD in my right eye, and “wet” in my left. Wet is the worse of the two. Both eyes have “drusens,” which are yellow deposits under the retina. These are early signs of MD but they alone don’t cause severe vision loss. The center of my left retina has a protuberance that is distorting my vision.
Every six weeks I have Lucentis injections in the white part of my left eye. Sounds like it would hurt, but it really doesn’t. They numb the eye before the injection. After the injection I use antibiotic drops for three days to protect against infection. At each visit the doctor takes more pictures to check for change in my left eye. Unfortunately, there’s been no improvement. But it hasn’t gotten worse, so maybe injections have held off progression of the disease. The injections are very costly, so make sure your insurance company agrees to pay before you take them. I also take “AREDS” which is a vitamin complex very rich in eye nutrients. And I take lutein, long considered helpful for eye health. My new glasses include a prism in my left lens that has helped a lot for my distant vision. My reading glasses don’t help much; I actually read better with my left eye closed.
There is an important conference for retina specialists in New York next month. I am hoping to learn results of recent clinical trials to determine other treatment options. I read that vitamin B complex and folic acid have been somewhat effective, but the test results were not at all conclusive. I’m taking them just in case they can help. There are so many researchers working on finding a cure, I'm sure it won't be too long. Good luck and keep your spirits up.
Use the downloadable Amsler grid.
It’s important that anyone diagnosed with macular degeneration check their eyes with the Amsler grid daily and report any changes to the eye doctor. This site also has the latest news articles on the disease. By the way, smokers are 2½ times more likely to get macular degeneration—one more reason to kick the habit.
Exciting new research offers hope for a cure.
I also have macular degeneration. It is the number one cause of visual loss in the U.S., and as people live longer it is expected to become even more prevalent. I read an online article in The Times entitled “Blind to be cured with stem cells” that gave me lots of hope. In London they are experimenting with laboratory trials on animals, replacing degenerated cells with new ones created from embryonic stem cells. The trials have been successful. While the therapy may not be available for six or seven years, it is encouraging that Pfizer, the world’s largest pharmaceutical research company, will produce the artificial membranes on which the embryonic stem cells are placed. Also it appears the treatment may take less than an hour as an outpatient procedure.
For more information go to:www.maculardegenerationassociation.org
By Philip Moeller
Personal experience with macular degeneration.
I have macular degeneration (MD) in both eyes. The Amsler grid is used to determine if you have MD. When I look at the grid with just my right eye all of the lines of the grid seem straight and clear. With my left eye the lines are wavy and distorted. My ophthalmologist diagnosed macular degeneration and sent me to a retina specialist. My mother and both of her siblings had MD, so I was genetically predisposed to get it. The retina specialist took pictures of my macula, the central part of the retina that provides for sharp, clear vision. The pictures showed I had “dry” MD in my right eye, and “wet” in my left. Wet is the worse of the two. Both eyes have “drusens,” which are yellow deposits under the retina. These are early signs of MD but they alone don’t cause severe vision loss. The center of my left retina has a protuberance that is distorting my vision.
Every six weeks I have Lucentis injections in the white part of my left eye. Sounds like it would hurt, but it really doesn’t. They numb the eye before the injection. After the injection I use antibiotic drops for three days to protect against infection. At each visit the doctor takes more pictures to check for change in my left eye. Unfortunately, there’s been no improvement. But it hasn’t gotten worse, so maybe injections have held off progression of the disease. The injections are very costly, so make sure your insurance company agrees to pay before you take them. I also take “AREDS” which is a vitamin complex very rich in eye nutrients. And I take lutein, long considered helpful for eye health. My new glasses include a prism in my left lens that has helped a lot for my distant vision. My reading glasses don’t help much; I actually read better with my left eye closed.
There is an important conference for retina specialists in New York next month. I am hoping to learn results of recent clinical trials to determine other treatment options. I read that vitamin B complex and folic acid have been somewhat effective, but the test results were not at all conclusive. I’m taking them just in case they can help. There are so many researchers working on finding a cure, I'm sure it won't be too long. Good luck and keep your spirits up.
Use the downloadable Amsler grid.
It’s important that anyone diagnosed with macular degeneration check their eyes with the Amsler grid daily and report any changes to the eye doctor. This site also has the latest news articles on the disease. By the way, smokers are 2½ times more likely to get macular degeneration—one more reason to kick the habit.
Exciting new research offers hope for a cure.
I also have macular degeneration. It is the number one cause of visual loss in the U.S., and as people live longer it is expected to become even more prevalent. I read an online article in The Times entitled “Blind to be cured with stem cells” that gave me lots of hope. In London they are experimenting with laboratory trials on animals, replacing degenerated cells with new ones created from embryonic stem cells. The trials have been successful. While the therapy may not be available for six or seven years, it is encouraging that Pfizer, the world’s largest pharmaceutical research company, will produce the artificial membranes on which the embryonic stem cells are placed. Also it appears the treatment may take less than an hour as an outpatient procedure.
For more information go to:www.maculardegenerationassociation.org
Wednesday, September 2, 2009
Acucela to Present at the Rodman & Renshaw 11th Annual Healthcare Conference
Acucela, a clinical-stage biotechnology company focused on developing new treatments for blinding eye diseases, announced today that Ryo Kubota, M.D., Ph.D., Acucela’s chairman, president and chief executive officer, will present a company update at the Rodman & Renshaw 11th Annual Healthcare Conference.
The presentation is scheduled for 4:55 p.m. EDT on Wednesday, September 9, 2009 at the New York Palace Hotel in New York City.
“We look forward to presenting an overview of Acucela and more details about our recent clinical progress at the Rodman & Renshaw Healthcare Conference,” stated Dr. Kubota. “With the need for effective blinding eye disease treatments becoming even more critical as our population ages, Acucela is developing a new, oral drug therapy for the leading cause of blindness in people over the age of 50, dry age-related macular degeneration (“dry AMD”). We’re excited to discuss how we’re approaching this challenging condition, which affects 26 million people worldwide and for which there is currently no approved treatment.”
About Acucela Inc.
Acucela Inc. is a clinical-stage biotechnology company focused on leveraging promising science in visual cycle modulation (VCM) to develop new methods for treating blinding eye diseases that affect tens of millions of people worldwide. The company’s orally-delivered VCM therapies, which selectively target cells within the retina to protect visual acuity, have the potential to be used to treat several devastating eye diseases, including dry age-related macular degeneration (AMD), retinopathy of prematurity, Stargardt disease and diabetic retinopathy.
The presentation is scheduled for 4:55 p.m. EDT on Wednesday, September 9, 2009 at the New York Palace Hotel in New York City.
“We look forward to presenting an overview of Acucela and more details about our recent clinical progress at the Rodman & Renshaw Healthcare Conference,” stated Dr. Kubota. “With the need for effective blinding eye disease treatments becoming even more critical as our population ages, Acucela is developing a new, oral drug therapy for the leading cause of blindness in people over the age of 50, dry age-related macular degeneration (“dry AMD”). We’re excited to discuss how we’re approaching this challenging condition, which affects 26 million people worldwide and for which there is currently no approved treatment.”
About Acucela Inc.
Acucela Inc. is a clinical-stage biotechnology company focused on leveraging promising science in visual cycle modulation (VCM) to develop new methods for treating blinding eye diseases that affect tens of millions of people worldwide. The company’s orally-delivered VCM therapies, which selectively target cells within the retina to protect visual acuity, have the potential to be used to treat several devastating eye diseases, including dry age-related macular degeneration (AMD), retinopathy of prematurity, Stargardt disease and diabetic retinopathy.
Subscribe to:
Comments (Atom)
