NeoStem Awarded Second Year of NIAID Research Grant for the Development of VSEL Technology for Radiation Exposure
New York, March 28, 2013 -- NeoStem, Inc. (NYSE MKT:NBS) ("NeoStem" or the "Company"), a leader in the emerging cellular therapy industry, today announced that it has been awarded the second year of a two year grant totaling $595,252 for the "Development of Human, Autologous, Pluripotent Very Small Embryonic Like (VSELs) Stem Cells as a Countermeasure to Radiation Threat", Grant Number 5R43AI098325-02 from the National Institute of Allergy and Infectious Diseases (NIAID), a division of the National Institutes of Health (NIH). This peer reviewed grant was awarded to support research to be headed by Denis O. Rodgerson, Ph.D., Director of Stem Cell Science for NeoStem and Mariusz Ratajczak, M.D., Ph.D., who is the head of the Stem Cell Biology Program at the James Graham Brown Cancer Center at the University of Louisville and co-inventor of VSELTM Technology.
This award funds studies to investigate the potential of very small embryonic-like stem cells as a countermeasure to radiological and nuclear threat. The product candidate, which is an autologous stem cell therapy derived from the patient's own stem cells, will be developed to rescue patients who have been exposed to radiation due to nuclear accident or terrorist threat and to treat cancer patients who have undergone radiation therapy and who consequently have compromised immune systems. The award included $295,252 for the first year and $300,000 for the second year of the project.
Dr. Denis O. Rodgerson, Director of Stem Cell Science for NeoStem, said, "We are very pleased that our research has met its interim requirements and been awarded its second year of funding. Those exposed to acute high-dose radiation have compromised immune systems such that the virulence and infectivity of biological agents is dramatically increased. Death can occur within 1-6 weeks following radiation exposure. Currently, there is only one intervention that saves a fatally irradiated person – a rescue through stem cell transplantation. VSELs might be an ideal cell therapy to regenerate the body's immune system and repair other tissues damaged by radiation exposure. Most importantly, early studies show VSELs are resistant to lethal radiation which destroys other immune system restoring stem cells in the body, making autologous treatment post-exposure possible."
Dr. Robin L. Smith, Chairman and CEO of NeoStem, added, "NeoStem is pleased that the NIAID is continuing to fund this cutting edge technology that we hope will reinvent the treatment landscape for acute radiation syndrome. We also expect to file an IND with the FDA in late 2013 or early 2014 to initiate a NIH funded human clinical study treating periodontitis with VSELs TM."
About VSELTM Technology
Mariusz Ratajczak, M.D., Ph.D., head of the Stem Cell Biology Program at the James Graham Brown Cancer Center at the University of Louisville, discovered that mammalian bone marrow contains a heterogeneous population of stem cells that has properties similar to those of embryonic stem cells. These cells, first described in mice, are referred to as very small embryonic-like stem cells, "VSELs TM" or "VSEL TM stem cells". We are engaged in research and development of new therapies based on VSEL TM Technology and pursuant to our VSEL TM Technology license agreement with the University of Louisville, we have the exclusive, world-wide rights, to technology and know-how relating to very small embryonic-like stem cells. These patent applications, filed in the U.S. and abroad, relate to VSEL TM stem cell methods of isolation and treatment of disease.
The use of human VSELsTM for regenerative medicine presents the possibility of capturing the key advantages associated with embryonic stem cells without the ethical or moral dilemmas associated with the use of fetal cells, or the potential negative biological effects associated with embryonic stem cells, such as their propensity to form tumors. In addition, VSELs TM offer the advantage of using autologous stem cells (i.e., the patient's own cells) for therapy, as opposed to having to rely on donor cells that are susceptible to immune rejection. Our research has identified cells in human blood and bone marrow that have many of the key properties described for murine VSELs TM. This research includes evidence of primitivism, pluripotency and tri-lineage differentiation. These observations provide the groundwork for the development of VSEL TM therapies to regenerate or repair damaged or diseased tissues in human subjects. www.vseltechnology.com
About NeoStem, Inc.
NeoStem, Inc. ("NeoStem" or the "Company") is a leader in the emerging cellular therapy industry. Our business model includes the development of novel proprietary cell therapy products as well as operating a contract development and manufacturing organization ("CDMO") providing services to others in the regenerative medicine industry. The combination of a therapeutic development business and revenue-generating service provider business provides the Company with capabilities for cost effective in-house product development and immediate revenue and cash flow generation. www.neostem.com
Forward-Looking Statements for NeoStem, Inc.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management's current expectations, as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include statements herein with respect to the successful execution of the Company's business strategy, including with respect to the Company's research and development and clinical evaluation efforts for cellular therapies, including with respect to AMR-001, the future of the regenerative medicine industry and the role of stem cells and cellular therapy in that industry and the Company's ability to successfully grow its contract development and manufacturing business. The Company's actual results could differ materially from those anticipated in these forward- looking statements as a result of various factors. Factors that could cause future results to materially differ from the recent results or those projected in forward-looking statements include the "Risk Factors" described in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 11, 2013 and in the Company's periodic filings with the Securities and Exchange Commission. The Company's further development is highly dependent on future medical and research developments and market acceptance, which is outside its control.
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