Cell therapeutics company NeoStem (NYSEAMEX:NBS) Tuesday announced that it has been awarded a $1.22 million, two-year grant for a phase 2 clinical study of bone repair using a stem cell product in humans.
Shares rose 1.54 per cent on the news, trading at 66 cents as at about 12:32 p.m. EDT.
The company said that the grant will support the investigation and first approved National Institutes of Health (NIH) clinical study for the "Repair of Bone Defects with Human Autologous Pluripotent Very Small Embryonic-Like Stem Cells (VSEL)". Enrollment for this study is expected to begin in 2013.
The study will evaluate VSEL stem cells as a potential treatment for periodontitis – an inflammation and infection of the ligaments and bones that support the teeth.
The product candidate, derived from a patient's own stem cells, is to be developed for use in the regeneration of bone tissue damaged by this disease, said the company.
"We are pleased and honored that NIH has agreed to support further studies on bone regeneration by using VSEL stem cells,” saidNeoStem’s director of grants and academic liaison, Dr. Denis O. Rodgerson.
“This is an extension of our successful NIH funded collaboration with Dr. Taichman showing the production of human bone from human VSELs in a mouse model."
NeoStem said that the VSEL study will be headed by Rodgerson, in collaboration with co-investigators Dr. Russell Taichman and Dr. Laurie McCauley of the University of Michigan.
The award includes $706,682 for the first year and $515,172 for the second year of the project, and will cover the cost of the Investigational New Drug submission to the Food and Drug Administration (FDA) for the product candidate.
The company noted that studies have shown that periodontal inflammation could have a role in the initiation or progression of coronary heart disease and stroke. It added that market research experts estimate that severe periodontal disease represents a market between $1.25 and $1.5 billion annually.
"The chance to continue to partner with NeoStem to further develop regenerative therapies is significant,” said Dr. Taichman, University of Michigan professor and co-director of the scholars program in dental leadership.
NeoStem’s chairman and CEO, Dr. Robin L. Smith, added: "We are very excited about this important step of funding for what will be the first human clinical study for our VSEL technology.
“Not only will this study expand our knowledge of how autologous cell therapy can treat periodontitis and other bone defects, but it represents a milestone for NeoStem as we move our development of VSEL technology beyond animal models and into the clinic, paving the way for other potential VSEL trials."
NeoStem has a worldwide exclusive license to its VSEL technology. The company is focused on accelerating the development of proprietary cellular therapies and becoming a single source for collection, storage, manufacturing, therapeutic development and transportation of cells for cell based medicine and regenerative science globally.
It has adult stem cell operations in the U.S., a network of adult stem cell therapeutic providers in China and a 51-per-cent ownership interest in a Chinese generic pharmaceutical manufacturing company, which in September it was in the process of selling.
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