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NeoStem enjoys a second year of NIH grant support for periodontal stem cell therapy
NeoStem Inc., a player in the growing cell therapy industry, announced Sept. 13 that it has been awarded funds for the second year of a two-year grant totaling a little over $1.2 million, with $706,682 awarded in the first year and $515,172 for the second year of the project, to cover the cost of an Investigational New Drug (IND) submission to the U.S. Food and Drug Administration (FDA) for the product candidate.
The award, for "Repair of bone defects with human autologous pluripotent very small embryonic-like stem cells (VSEL)," is from the National Institute of Dental and Craniofacial Research of the U.S. National Institutes of Health (NIH). NeoStem's VSEL technology is an autologous therapy derived from a patient's own stem cells, and it is being developed for use in the regeneration of bone tissue damaged by periodontitis.
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 reports, and it anticipates submitting its IND filings in late 2013 or early 2014.
"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," said Dr. Robin L. Smith, chairman and CEO of NeoStem. "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."
Periodontitis is a severe form of periodontal disease, which is prevalent not just in the United States but which also affects up to 90 percent of the world population, according to NeoStem. The most severe cases of periodontal disease affect between 5 percent and 15 percent of the U.S. population, or between 15 million and 47 million Americans, the company notes, with the incidence of new cases of periodontal disease estimated to be growing at a 7 percent rate each year. Beyond the dental damage, 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 billion and $1.5 billion annually.
NeoStem describes VSEL cells as "a resident population of multipotent stem cells in the bone marrow involved in the turnover and regeneration of tissues." Reportedly, VSEL technology offers the potential to go beyond the paracrine effect, yielding cells that actually differentiate into the target tissue and create true cellular regeneration. Recent preclinical data in animal models suggest that VSELs may be capable of developing into cells of all three germ layers which, if substantiated by further research, could imply significant potential for restorative healing, according to NeoStem. Unlike in the case of classically defined pluripotent stem cells, the company adds, it is believed that VSELs do not contribute to teratoma formation.