First Patient Enrolled in Ocata Therapeutics' Phase 2 Study for Dry AMD

Ocata Therapeutics, Inc.

, a leader in the field of Regenerative Ophthalmology™, today announced that the first patient has been enrolled in the company's Phase 2 clinical trial using Ocata's proprietary RPE cells in patients with atrophic (dry) age-related macular degeneration (AMD). The purpose of the trial is to evaluate safety and explore efficacy as compared to a parallel control group. Interim top-line results from the first cohort is expected in the second quarter of 2016 and the interim read-out on the second two cohorts is expected by the end of 2016. Age-related macular degeneration is the leading cause of vision loss in people over the age of 50. Every year in the United States there are an estimated 1.8 million patients newly diagnosed with dry AMD, which occurs when light-sensitive photoreceptor cells in the macula, located in the center of the retina, slowly break down, causing vision loss. Photoreceptor breakdown is a consequence of loss or damage to the RPE layer. As the disease progresses, patients may have difficulty reading and recognizing faces. There is currently no proven medical therapy for dry AMD. "We expect this Phase 2 clinical study will provide important information about the ability of Ocata's fully differentiated RPE cells to treat dry age-related macular degeneration, when transplanted into the retina," commented Carl D. Regillo, MD, FACS, Director, Retina Service at Wills Eye Hospital and Professor of Ophthalmology, Jefferson Medical College. "We are pleased to be a participating site in this clinical trial, as we believe that Ocata's RPE program has the potential to be an effective treatment option for dry AMD, as well as other ophthalmological indications, such as Stargardt's Disease." This Phase 2 study will include up to three cohorts of up to 20 subjects each. Each of the cohorts will receive one week of immune suppressive therapy prior to surgery and then different immune suppression regimens following transplantation of the cells, to determine the safety and tolerability of 0, 6 and 12 weeks of post-transplant systemic immune suppression. Untreated patients will receive placebo treatment similar in appearance and administration to those who have received cellular transplants. "A key goal of this study is to more fully explore the efficacy signal that we reported in the Lancet in October of last year, with comparison to a control group of untreated patients rather than using the fellow eye for comparison. We believe that the data developed in this Phase 2 study will allow us to optimize the addressable patient population using well-controlled data while assessing potential endpoints for efficacy," said Eddy Anglade, M.D., Chief Medical Officer of Ocata. "We look forward to advancing into this next phase of development and we are grateful to the physicians and the patients who partner with us on these important programs. We expect that the data produced by this study will provide valuable guidance for the design of a Phase 3 program and could ultimately inform our commercial strategies."