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NEW YORK, Sept. 13, 2013 (GLOBE NEWSWIRE) -- A release announced earlier today made reference to a Phase 2 clinical trial or study when the proper reference should have been to a Phase 2 SBIR grant, as contained in the amended and corrected release below.
NeoStem, Inc. (Nasdaq:NBS) ("NeoStem" or the "Company"), an emerging leader in the fast growing cell therapy industry, today announced that it has been awarded funds for the second year of a two year grant totaling $1,221,854 for "Repair of Bone Defects with Human Autologous Pluripotent Very Small Embryonic-Like Stem Cells (VSEL)," from the National Institute of Dental & Craniofacial Research ("NIDCR"), a division of the National Institutes of Health ("NIH"). This portion of the peer reviewed grant is to support the completion of a Phase 2 Small Business Innovative Research Program ("SBIR") investigation and first approved NIH clinical study of VSELs™ in humans. Enrollment for this study is expected to begin in 2014.
VSEL™ Technology, an autologous therapy derived from a patient's own stem cells, is being developed for use in the regeneration of bone tissue damaged by periodontitis. The study will be managed by NeoStem in collaboration with co-investigators Drs. Russell Taichman and Laurie McCauley of the University of Michigan. The award, comprised of $706,682 for the first year and $515,172 for the second year of the project, will cover the cost of an Investigational New Drug ("IND") submission to the FDA for the product candidate.
The required preclinical data, cell manufacturing processes and clinical protocols necessary for submission of an IND to the FDA are in the final stages of preparation. The Company anticipates IND submission in late 2013 or early 2014.
Dr. Robin L. Smith, Chairman and CEO of NeoStem, commented, "We are very excited about our progress towards the IND submission for what we expect to be the first human clinical study for our VSEL™ Technology and for the support of the NIH. We continue to pursue opportunities for non-dilutive financing of our programs, such as our recently awarded phase 1 NIH grant to investigate VSEL™ Technology for the treatment of scleroderma."