WORCESTER, Mass.--(BUSINESS WIRE)--Advanced Cell Technology, Inc. (“ACT”; OTCBB: ACTC) announced today that it has completed key 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 US Food and Drug Administration (FDA) in November. 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. The Company 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.
