ACT’s Clinical Partner Receives FDA Approval To Initiate Clinical Trial Using The Company’s HESC-derived Cells To Treat Severe Myopia
Advanced Cell Technology, Inc.’s (“ACT”; OTCBB: ACTC or the “Company”), clinical partner, the University of California, Los Angeles (UCLA), has received approval of its Investigator Investigational New Drug (IND) Application with the US Food and Drug Administration (FDA), led by Steven Schwartz, M.D., Ahmanson Professor of Ophthalmology at the David Geffen School of Medicine at UCLA and retina division chief at UCLA's Jules Stein Eye Institute, to initiate a Phase I/II study using ACT’s retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs) to treat myopic macular degeneration (MMD, or myopia), commonly known as nearsightedness. The primary focus of the study will be to evaluate the safety in patients with severe myopia of the type that causes fissures in the RPE layer of the eye. Dr. Schwartz is the principal investigator in each of ACT’s two Phase I/II clinical trials for Stargardt's macular dystrophy and dry age-related macular degeneration (dry AMD) using RPE cells derived from hESCs. The approval was announced by Dr. Schwartz in his presentation at Bascom Palmer Eye Institute’s tenth annual angiogenesis meeting, “Angiogenesis, Exudation, and Degeneration 2013,” on Saturday, February 9 in Miami, Fla.
“We are encouraged by Dr. Schwartz’s keen interest in the evaluation of ACT’s RPE cells in potentially treating myopia,” commented Gary Rabin, chairman and CEO of ACT. “We are pleased to be on track to broaden the scope of our RPE program with the initiation of the new Investigator IND. Nearsightedness is a very common condition, worldwide, and it is estimated that roughly 30% of cases are high, or severe, myopia.”
The myopia clinical trial will follow a similar protocol as the company’s three other human clinical trials in the U.S. and Europe using hESC-derived RPE cells to treat forms of macular degeneration. The trial will enroll a total of 12 patients, with cohorts of three patients in an ascending dosage format. The trial is a prospective, open-label study designed to determine the safety and tolerability of hESC-derived RPE cells following sub-retinal transplantation into patients with myopia at 12 months, the study’s primary endpoint.
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