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CellCure reports positive safety for the product

Sep. 18, 2014

Additional success for HBL, the cell stem company that it owns through clinical trials:

Cell Cure of the HBL Group reports positive safety and efficacy reports for the stem cell product to treat retinal degeneration in the framework of preclinical trials, and will file an FDA application to commence Phase I/II trials


The HBL Group and its American partner, Bio Time, report that the OpRegen® cells have been found to be efficient in long-term treatment based on the trial conditions and maintained the visual capabilities of the animals


Charles S. Irving, CEO of Cell Cure

“We are preparing to commence the clinical trials that will enable use for the first time of RPE cells to treat the more severe stage of macular degeneration”



Israel, Jerusalem, September 17, 2014 – the Israeli Cell Cure Neurosciences of the publically traded HBL Group (TA: HDST, OTC: HADSY) is preparing for the beginning of clinical trials for the Company’s product, OpRegen, for innovative treatment using human embryonic stem cells of macular degeneration disease. The HBL Group and its American partner, Bio Time (NYSE MKT: BTX), report today that Cell Cure Neurosciences has received final positive results in a series of efficacy and safety pre-clinical trials of the OpRegen product that were performed in accordance with the instructions of the FDA by leading clinical research companies (CROs).


The results of the successfully completed trials will be currently used by Cell Cure in order to file an IND to the FDA prior to the Phase I/IIa trials in patients with age-related macular degeneration (dry-AMD) through the OpRegen® cells developed by Cell Cure.


Cell Cure, of which the HBL Group holds 21.2% of its share capital, is engaged in research and development in the field of treatment of neurodegenerative disease by way of the replacement of cells, while its primary objectives are to develop a product for the treatment of retinal degeneration, including macular degeneration (AMD). The OpRegen product treats retinal degeneration, including macular degeneration, of the cells located in the center of the retina and based on pigment cells in the back of the retina (RPE).


The main cause for AMD disease is the death of the RPE cells located under and supporting the retina. The unique treatment developed by Cell Cure for healing dry-AMD is the transplantation of pigment cells of the retina, RPE cells, produced from embryonic stem cells. The medical treatment is a procedure in which RPE cells that are designated to renew and replace the degenerating RPE cells in the patient’s eye are injected, and to stop the progression of the disease. Currently, there is no relatively inexpensive and simple solution for the supply of RPE cells, while embryonic stem cells are a source that enables receipt of an unlimited amount of RPE cells. Additionally, there is currently no approved medical treatment for dry-macular degeneration disease.


“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 animal’s visual performance that would normally decay over time in this disease model,” said Benjamin Reubinoff, MD, PhD, Chief Scientific 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. “Furthermore, the protection of the animal’s vision from decay was dependent on the dose of OpRegen® cells. 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 Cure’s team has made in preparing for the company’s IND submission to the FDA,” said Dr. Charles S. Irving, Cell Cure’s 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.”


Cell Cure Neurosciences was established in 2005. On the date of its incorporation, Cell Cure was under the full control of a Singapore company known as ES Cell International Pte, and in the second quarter of 2010, the Singapore company ESI was acquired by the American traded company known as BioTime. Further to HBL’s investment in Cell Cure, ESI granted Cell Cure an exclusive license for the use of the IP in order to develop and produce the nerve cells for treatments to replace the cell of degenerative nerve diseases in humans. Cell Cure was given an exclusive global license in the field of treatment of neurodegenerative diseases, chiefly Parkinson’s. In 2010, a research and option for an exclusive sublicense agreement was signed between Cell Cure and Teva for the development and commercialization of OpRegen.


The research group of Prof. Rubinoff and Prof. Banin of the Hadassah Hospital developed the method for direct differentiation of human embryonic stem cells to RPE cells that may supply the quantity required for clinical treatment of all current and future dry-AMD patients globally. For about four years, Cell Cure has created RPE cells under cGMP conditions for use in clinical trials. To date, to the best of our knowledge, there is no additional factor that has succeeding in producing these cells without use of animal-derived materials.


Transplantation of the pigment cells in dry-AMD patients is expected to prevent the continued degeneration of the retina due to the lack of function of the patients’ pigment cells. Cell Cure is, in practice, developing two products: RPE cells in suspension (OpRegen) and RPE cells attached to a biological membrane (OpRegen Plus).


About 20-30 million individuals in the USA are at risk of contracting AMD, and the forecast is that the number of patients will increase with the increase of the population. About 7.3 million individuals in the USA are at an early stage of the disease in at least one eye. In addition, about 1.75 million individuals in the USA are patients at an advanced stage, although this number is expected to increase to about 2.95 million in 2020.


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