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September 26, 2014

ACT completes treatment stage of Phase 1 Trial in UK

Advanced Cell Technology has completed the initial phase of its clinical-trial treatment for Stargardt’s macular degeneration (SMD), a genetic eye disorder that causes progressive vision loss, the Marlborough company announced.

The successful transplantation of the company’s retinal pigment epithelium (RPE) cells, which are derived from human embryonic stem cells, in the last of 12 patients represents the completion of the enrollment stage of this trial, the biotech firm said.

“The completion of enrollment and treatment of all patients in the Phase 1 portion of our U.K. clinical trial is a significant milestone for ACT and its RPE programs,” Chief Medical Officer Eddy Anglade said in a statement. “We look forward to analyzing the data as we continue to advance our clinical programs. To date, no cell or immune-related adverse events have been reported in any of the patients treated, indicating that our RPE cell therapy appears to be safe and well-tolerated at all of the doses planned for the study.”

The company said it continues to work with U.S. and European regulatory agencies to start Phase 2 clinical trials of its RPE cell therapy in patients suffering from SMD, as well as dry age-related macular degeneration (AMD), a leading cause of severe vision loss in people older than 60.

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