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news.Advanced Cell Technology, a biotechnology company, has completed animal studies in connection with its Phase I multicenter study using embryonic stem cell derived Retinal Pigment Epithelium (RPE) cells to treat patients with Stargardt’s Macular Dystrophy (SMD), for which it filed an Investigational New Drug Application (IND) with the FDA in November.
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Advanced Cell Technology said that the studies demonstrated an excellent safety profile with no safety signals such as tumors or ectopic tissues. The studies were designed to address the FDA’s request for additional data on tumorigenicity and biodistribution.
Advanced Cell Technology believes that the data will support the FDA granting clearance for the company to commence the SMD study in humans later this year. The studies were completed in conjunction with Sinclair Research, based in Columbia, Missouri, Charles River Labs, MPI and Althea Labs, which have been the company’s outside independent collaborators on both studies.
The Phase I trial will be a prospective, open-label study that is designed to determine the safety and tolerability of the retinal pigment epithelium (RPE) cells following sub-retinal transplantation to advanced patients with SMD.
William Caldwell IV, chairman and CEO of Advanced Cell Technology, said: “We believe these animal studies demonstrate an excellent safety profile for our RPE cell therapy . We look forward to concluding our discussions with the FDA so that we can commence our study later this year.”