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-- Preliminary Data Indicate Safety and Tolerability in Adult Patients and Complement Recently Published 12-Month Data Indicating Feasibility and Potential Efficacy in Children With T1DM --
-- Initiation of Phase 2 Study Expected for Q3 2014 --
NEW YORK, June 16, 2014 (GLOBE NEWSWIRE) -- NeoStem, Inc. (Nasdaq:NBS) ("NeoStem" or the "Company"), a leader in the emerging cellular therapy industry, today announced the presentation of the results of an open-label dose escalation Phase 1 clinical study of autologous T regulatory cell (Treg) immunotherapy for type 1 diabetes mellitus (T1DM) indicating safety and tolerability following administration. This study, funded by the Juvenile Diabetes Research Foundation and conducted by Dr. Stephen Gitelman at University of California, San Francisco (UCSF) and Dr. Kevan Herold at Yale University, provides preliminary data that support developing a novel therapy for the treatment of T1DM with the goal of inducing immune tolerance and preserving pancreatic beta cell function. The results were presented by Dr. Gitelman at this week's American Diabetes Association 74
th Scientific Sessions in San Francisco.
The autologous T-regulatory cell product that is being developed by NeoStem is designed to restore immune balance by enhancing Treg number and function. The cells are produced through a methodology developed by Jeffrey Bluestone, PhD and colleagues at UCSF for isolating, expanding and infusing patients' own Tregs. A natural part of the human immune system, Tregs help maintain balance in the immune system, which is thought to be out of balance in the setting of autoimmune diseases such as T1DM.
1 The technology, study data and any resulting product (termed NBS-03) are licensed exclusively by NeoStem. NeoStem expects to initiate a Phase 2 new onset T1DM study in Q3 2014.
"These positive preliminary data provide initial evidence of safety and tolerability of an autologous cell therapy designed to stop the immune attack on the pancreas. Some treated patients had stable beta cell function for up to 24 months following the Treg treatment," said Dr. Gitelman. "We are excited about the Phase 2 program beginning later this year to further assess safety and to evaluate the efficacy of this novel therapy."