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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.
("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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