New York, July 15, 2013 — NeoStem, Inc. (NYSE MKT:NBS) (“NeoStem” or the “Company”), a leader in the emerging cellular therapy market, today announced that the Company has executed agreements with the University of California, San Francisco and the laboratories of Jeffrey Bluestone, PhD, and Qizhi Tang, PhD, to collaborate on the development of human Regulatory T cells (“Tregs”) for the treatment of type 1 diabetes (“T1D”), steroid resistant asthma, and organ transplant rejection. This collaboration advances NeoStem’s role in the development and commercialization of immunomodulatory cellular therapeutic products for the treatment of intractable diseases involving the immune system.
“Worldwide, type 1 diabetes affects over 340 million people, and has an economic cost of over $174 billion in the U.S. alone. Severe asthma affects another 60 million people,” said Dr. Robin L. Smith, Chairman and CEO of NeoStem. “Our collaboration with Drs. Bluestone and Tang, industry leaders in Treg research, and UCSF represents a significant advance in the development of our Athelos technology platform.”
Dr. Bluestone is the A.W. and Mary Margaret Clausen Distinguished Professor and Executive Vice Chancellor and Provost, UCSF and is a leader in the field of Tregs and immunotherapy of autoimmune and inflammatory diseases. Dr. Bluestone has published over 400 articles on T cell biology and activation, and regulation and control of normal and pathogenic immune responses. Dr. Tang is an Associate Professor in the Department of Surgery and has been working with Dr. Bluestone for over a decade on the clinical application of Tregs in autoimmunity and organ transplantation.
This collaboration advances NeoStem’s Treg program towards a clinical Phase 2 trial to evaluate the efficacy of autologous Tregs in T1D. Under the agreements NeoStem will manufacture a Treg product consisting of polyclonally expanded Tregs for the planned Phase 2 trial to treat patients newly diagnosed with T1D and will collaborate with Dr. Bluestone on allo-specific Tregs for organ transplant tolerance in another Phase 2 study. Additionally, NeoStem plans to sponsor a Phase 1a/2b study on the use of Tregs for the treatment of steroid resistant asthma. The collaboration includes the research effort to develop the next generation of Treg products for therapeutic use.
“I am excited to begin this collaboration with NeoStem,” said Dr. Bluestone. “Their in-house expertise in development and manufacturing will serve as a complement to my team at UCSF and, through this partnership, I look forward to building on a strong existing foundation, moving these products through clinical development to treat diseases which have long been a focus of my own clinical research.”
“NeoStem has core expertise in the development and conduct of cell therapy based trials,” said Dr. Andrew L. Pecora, Chief Medical Officer of NeoStem. “This collaboration accelerates the development of our immunomodulatory therapeutic portfolio, enabling the initiation of a Phase 2 trial in type 1diabetes and a Phase 1b/2a trial in steroid resistant asthma. This development significantly diversifies and augments NeoStem’s cell therapy pipeline, which includes a Phase 2 cardiovascular clinical trial which is expected to complete enrollment in 2013.”
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 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.
For more information, please visit: www.neostem.com.
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 and Tregs, 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 SEC. The Company’s further development is highly dependent on future medical and research developments and market acceptance, which is outside its control.
The information stated above was prepared by NeoStem, Inc., and reflects solely the opinion of the corporation. Nothing in this statement shall be construed to imply any support or endorsement of NeoStem, or any of its products, by The Regents of the University of California, its officers, agents and employees.