We are very pleased with the safety data obtained in two animal species that demonstrate that OpRegen cells survive following transplantation for a long period of time and do not result in teratoma formation or any other type of pathology. The efficacy of the OpRegen cells was evaluated in the Royal College of Surgery rat model of retinal degeneration, which is a well-established animal model of retinal degeneration which has been extensively used to evaluate various potential cell therapies. The OpRegen cells were found to remain therapeutically functional over long periods and to maintain the animals visual performance that would normally decay over time in this disease model, said Benjamin Reubinoff, MD, PhD, Chief Scientific Officer of Cell Cure and Chairman of Obstetrics and Gynecology and Director of the Hadassah Human Embryonic Stem Cell Research Center at Hadassah Medical Center, Jerusalem, Israel. Furthermore, the protection of the animals vision from decay was dose dependent. As an additional indicator of therapeutic potential, the number of cone photoreceptors, which are responsible for fine vision in humans and are degenerating in the macula of dry-AMD patients, was found to remain constant over an extended period in the animal model.
We are very pleased with the progress that Cell Cures team has made in preparing for the companys FDA submission, said Charles S. Irving PhD, Cell Cures CEO. We look forward to initiating the clinical trial that will utilize for the first time high quality, xeno-free grade RPE cells for the treatment of geographic atrophy, the severe stage of dry-AMD.
About Age-Related Macular Degeneration
Age-related macular degeneration (AMD) is one of the major diseases of aging and is the leading cause of visual impairment in Americans 55 years of age and older. AMD affects the macula, which is the part of the retina responsible for sharp, central vision that is important for facial recognition, reading and driving. There are two forms of AMD. The dry form (dry-AMD) advances slowly and painlessly until it reaches the severe form called geographic atrophy (GA), which may result in legal blindness. About 10% of patients with dry-AMD develop wet-AMD, which is an acute disease and can lead to blindness in a matter of weeks. Wet-AMD can be treated with currently-marketed angiogenesis inhibitors such as Lucentis or Eylea, however, such products typically require frequent injections, and patients often continue to suffer from the continued progression of the underlying dry-AMD disease process. There is no FDA-approved treatment for dry-AMD for which some seven million people in the US have the intermediate form of the disease and have a high risk for developing GA. The market opportunity for a treatment for GA has been estimated at over $5 billion globally. Current estimated sales of angiogenesis inhibitors for the treatment of the wet form of AMD are estimated to be about $7 billion worldwide. The root cause of the larger problem of dry-AMD is believed to be the degeneration of a particular type of cell in the retina called "retinal pigment epithelial" (RPE) cells. One of the most exciting therapeutic approaches to dry-AMD is the transplantation of healthy, young RPE cells to replace the patients old degenerating RPE cells. One of the most promising sources of healthy RPE cells is from pluripotent stem cells.
About OpRegen
Cell Cure's OpRegen consists of RPE cells that are produced using a proprietary process that drives the differentiation of human embryonic stem cells into high purity RPE cells. OpRegen is also xeno-free", meaning that no animal products were used either in the derivation and expansion of the human embryonic stem cells or in the directed differentiation process. The avoidance of the use of animal products eliminates some safety concerns. OpRegen is formulated as a suspension of RPE cells. Preclinical studies in mice have shown that OpRegen transplanted subretinally as a suspension of cells can rapidly organize into their natural monolayer structure and survive throughout the lifetime of the animal. OpRegen will be an off-the-shelf allogeneic product provided to retinal surgeons in a final formulation ready for transplantation. Unlike treatments that require multiple injections into the eye, such as currently-marketed products like Lucentis and Eylea for wet-AMD, it is expected that OpRegen will be administered in a single procedure.
About Cell Cure Neurosciences Ltd.
Cell Cure Neurosciences Ltd. was established in 2005 as a subsidiary of ES Cell International Pte. Ltd. (ESI), now a subsidiary of BioTime, Inc. (NYSE MKT: BTX). Cell Cures second largest shareholder is HBL Hadasit Bio-Holdings, (TASE: HDST, OTC: HADSY). Cell Cure is located in Jerusalem, Israel on the campus of Hadassah Medical Center. Cell Cure's mission is to become a leading supplier of human cell-based therapies for the treatment of retinal and neural degenerative diseases. Its technology platform is based on the manufacture of diverse cell products sourced from clinical-grade (GMP-compatible) human embryonic stem cells. Its current focus is the development of retinal pigment epithelial (RPE) cells for the treatment of age-related macular degeneration. Cell Cure's major shareholders include BioTime, Inc., HBL Hadasit Bio-Holdings Ltd., Teva Pharmaceuticals Industries Ltd. (NYSE: TEVA), and Asterias Biotherapeutics (OTCBB: ASTY). Additional information about Cell Cure can be found on the web at http://www.cellcureneurosciences.com. A video of a presentation by Cell Cures CEO Dr. Charles Irving is available on BioTimes web site.
About BioTime
BioTime is a biotechnology company engaged in research and product development in the field of regenerative medicine. Regenerative medicine refers to therapies based on stem cell technology that are designed to rebuild cell and tissue function lost due to degenerative disease or injury. BioTimes focus is on pluripotent stem cell technology based on human embryonic stem (hES) cells and induced pluripotent stem (iPS) cells. hES and iPS cells provide a means of manufacturing every cell type in the human body and therefore show considerable promise for the development of a number of new therapeutic products. BioTimes therapeutic and research products include a wide array of proprietary PureStem progenitors, HyStem hydrogels, culture media, and differentiation kits. BioTime is developing Renevia (a HyStem product) as a biocompatible, implantable hyaluronan and collagen-based matrix for cell delivery in human clinical applications, and is planning to initiate a pivotal clinical trial around Renevia, in 2014. In addition, BioTime has developed Hextend, a blood plasma volume expander for use in surgery, emergency trauma treatment and other applications. Hextend is manufactured and distributed in the U.S. by Hospira, Inc. and in South Korea by CJ HealthCare Corporation, under exclusive licensing agreements.
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BioTimes Subsidiary Cell Cure Neurosciences Ltd. Demonstrates the Safety and Efficacy of OpRegen in Preclinical ...