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January 27, 2014
09:09 EDTBTXBioTime, unit initiates PanC-Dx clinical development in U.S., China
BioTime and its subsidiary OncoCyte announced that OncoCyte has initiated clinical development of its bladder cancer diagnostic test, PanC-Dx, in both the U.S. and China. In the U.S., OncoCyte has entered into a clinical trial agreement with a leading medical institution with an international reputation for excellence and discovery, while in China, OncoCyte has entered into a fee-for-service agreement with China Medicine. The goal of these clinical studies is the testing of OncoCyte’s proprietary diagnostic technology in the most common type of bladder cancer, namely, urothelial carcinoma. Investigators in the collaborating institutions are collecting urine samples from patients at time of bladder cancer diagnosis as well as from those with a risk for recurrent disease. A statistical analysis of these and other results will be performed to determine the overall relative performance of OncoCyte’s PanC-Dx markers. Completion of these studies is expected by late 2014.
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September 19, 2014
09:04 EDTBTXBioTime unit presents PanC-Dx data
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September 17, 2014
09:04 EDTBTXBioTime unit receives OpRegen preclinical safety and efficacy study results
BioTime, HBL Hadasit Bio-Holdings and Cell Cure Neurosciences announced that Cell Cure has received the final results of a series of extensive preclinical safety and efficacy studies of its development-stage product designated OpRegen, which is intended for use in the treatment of dry form age-related macular degeneration. These studies were conducted by Cell Cure and contract research organizations in preparation for an IND filing with the Food and Drug Administration for a Phase 1/2a study in patients with geographic atrophy, the severe stage of dry-AMD. OpRegen is intended to be administered into the subretinal space of patients as a suspension of cells to treat this leading cause of blindness. The company said, "The protection of the animal’s vision from decay was dose dependent. As an additional indicator of therapeutic potential, the number of cone photoreceptors, which are responsible for fine vision in humans and are degenerating in the macula of dry-AMD patients, was found to remain constant over an extended period in the animal model.”

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