JERUSALEM, ISRAEL -- HBL Hadasit Bio-Holdings Ltd. (TASE: HDST, OTC: HADSY), and Cell Cure Neurosciences Ltd. (Cell Cure) today announced that Cell Cure has filed an Investigational New Drug (IND) application with the United States Food and Drug Administration (FDA) seeking to initiate a Phase I/IIa clinical trial of OpRegen® in patients with geographic atrophy (GA), the advanced stage of the dry form of age-related macular degeneration (dry-AMD).
OpRegen® consists of retinal pigment epithelial (RPE) cells derived from human embryonic stem cells and is intended to be administered as a single dose into the subretinal space of patients’ eyes in order to treat this leading cause of visual impairment.
“The filing of this IND is the culmination of 12 years of research and development starting at the Hadassah Human Embryonic Stem Cell Research Center at Hadassah University Medical Center, Jerusalem, Israel, under the direction of Prof. Benjamin Reubinoff, MD, PhD and continuing at Cell Cure Neurosciences Ltd.,” said Charles Irving Ph.D., Cell Cure’s CEO. “We look forward to initiating the clinical trial that will, for the first time, utilize xeno-free grade human embryonic stem cell derived RPE cells with high purity and potency, for the treatment of geographic atrophy, the most advanced stage of dry-AMD, age-based.”
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