Neostem Issues Correction to Earlier Release: Said Phase 2 Trial Reference Should Have Been Related to Phase 2 SBIR Grant
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."
Dr. Denis O. Rodgerson, Director of Grants and Academic Liaison for NeoStem, added, "We are pleased that we have met our interim milestones and NIH has agreed to award us funding for the second year of these studies on bone regeneration by using VSEL™ stem cells."
Periodontitis is a severe form of periodontal disease, which is prevalent in the U.S. and affects up to 90% of the world population. The most severe cases of periodontal disease affect between 5% and 15% of the U.S. population, or between 15 and 47 million Americans. The incidence of new cases of periodontal disease is estimated to be between 1 and 3 million Americans annually, and growing at a 7% rate each year. Studies have shown that periodontal inflammation could have a role in the initiation or progression of coronary heart disease and stroke. Market research experts have estimated that severe periodontal disease represents a market between $1.25 and $1.5 billion annually.
This research is supported by the National Institute of Dental & Craniofacial Research of the National Institutes of Health under Award Number 5R44DE022493-03. The content of this press release is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
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