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News Breaks | | | | January 10, 2013 | | 09:25 EDT |  | BCLI | BrainStorm Cell establishes safety of repeat doses of NurOwn in mice
BrainStorm Cell Therapeutics announced that it has successfully completed a 12-week repeat dose toxicity study with its NurOwn cells in mice. The company believes that the positive data from the study will support its efforts to obtain approval for a future repeat dose clinical study in ALS patients. The study was conducted at Harlan Israel’s laboratories, according to GLP standards of the FDA. The study protocol was approved by the Israeli Ministry of Health. In the study, the animals received up to three intramuscular injections of NurOwn, produced from cryopreserved, or frozen, cells at concentrations 50–100 times the currently administered clinical trial dose. The treatment was well tolerated, and no adverse clinical effects were observed. Analyses included cytokine profile assays, clinical pathology, necropsy and macroscopic examination, as well as histopathological examinations. BrainStorm is currently launching a Phase IIa combined treatment, dose-escalating trial of its NurOwn cell therapy candidate in ALS patients at the Hadassah Medical Center in Jerusalem. The company was recently fast-tracked by the Israeli Ministry of Health after reporting positive safety data for 12 patients in a Phase I/II trial. | |
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News For BCLI From The Last 14 Days Check below for free stories on BCLI the last two weeks. |
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