New Process Development Improvements Intended to Ensure Phase 3 and Commercial Readiness for Client
New York, NY, December 3, 2013-- NeoStem, Inc. (Nasdaq:NBS), and its subsidiary, Progenitor Cell Therapy, LLC ("PCT"), announced the expansion of PCT’s relationship with ImmunoCellular Therapeutics, Ltd. ("ImmunoCellular") (NYSE MKT:IMUC), a clinical-stage company that is developing immune-based therapies for the treatment of brain and other cancers, for current good manufacturing practices (cGMP) and development services for ImmunoCellular’s dendritic cell-based vaccines. PCT currently manufactures ICT-121, a dendritic cell vaccine targeting CD133 cells, in a Phase 1 clinical trial for recurrent glioblastoma multiforme (GBM) pursuant to a Services Agreement between the companies. PCT also manufactured Phase 2 clinical supplies of ICT-107, a dendritic cell-based vaccine targeting six tumor-associated antigens for newly diagnosed GBM. Under this newly executed Services Agreement, PCT will manufacture clinical supplies of ICT-140, a dendritic cell vaccine targeting seven ovarian cancer antigens, using process improvements PCT will develop that can be applied to the manufacture of all ImmunoCellular’s current vaccine product candidates, ICT-107, ICT-121 and ICT-140. These process improvements are intended to increase quality, consistency, efficiency, and cost-effectiveness, and support ImmunoCellular’s vaccine manufacturing requirements for conducting potential Phase 3 registration trials and for commercial manufacturing should these therapies receive Food and Drug Administration approval.
“Ensuring that ImmunoCellular has an established manufacturing process that can support pivotal registration programs and eventual commercial manufacturing for all our dendritic cell vaccines as they advance toward registration is foundational for building a leading cancer immunotherapy company,” said Andrew Gengos, ImmunoCellular Chief Executive Officer. “We look forward to continuing our partnership with PCT, and are pleased to be making this investment in process enhancements now.”
"We appreciate the opportunity to begin yet another project with ImmunoCellular as a manufacturing and development partner," said Robert A. Preti, PhD, President of PCT and Chief Scientific Officer of NeoStem. "PCT has developed significant expertise in the development and manufacture of dendritic cell vaccines, as well as other immunotherapies, over its 15 year history, including the experience of our long-term service for Dendreon for whom we provided manufacturing through pivotal studies of Provenge®, the first cell therapy approved for cancer treatment."
"With its East and West Coast facilities, PCT has unique expertise in manufacturing, regulatory, logistical transport and commercialization for therapeutics development, and we are pleased that our clients have confidence in the quality and cost-effectiveness of our operations to give us additional projects," said Robin L. Smith, M.D., MBA, Chairman and CEO of NeoStem. "We foresee meaningful client base growth as therapeutic development companies come to understand the critical importance of involving a skilled and experienced manufacturing partner and the cost-effectiveness of that partner possessing the ability to rapidly scale while providing excellent service."
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.
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 as well as efforts towards commercialization of 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, including growth based on the successful development and commercialization by PCT’s clients of their own cell-based therapies. 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.
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