NeoStem, Inc. ($NBS) and its subsidiary, Progenitor Cell Therapy, LLC ("PCT"), announced the execution of a Services Agreement with IRX Therapeutics, Inc. ("IRX") under which PCT will provide services to support IRX's development of IRX-2, a primary cell-derived biologic with multiple active cytokine components. IRX-2 is a cancer therapeutic designed to activate a patient's immune system to broadly restore immunity and overcome cancer-induced immune suppression. IRX has engaged PCT for the manufacture of an intermediate component referred to as IRX-2 Drug Substance for human clinical trials.
"We are pleased to reengage with IRX, a leader in advanced therapies for treatment of cancers, continuing our multi-year relationship with this client," said Dr. Robert A. Preti, President of PCT and Chief Scientific Officer of PCT and NeoStem. "We believe that PCT offers industry-leading experience and expertise that will continue to support IRX's development of IRX-2 for human clinical trials."
"We are excited to be working with one of the premier contract manufacturers, Progenitor Cell Therapy, in their Allendale facility. The expanded facility and experienced team will both help ensure that our product is manufactured to cGMP standards in a timely and efficient manner," added Jeffrey Hwang, Chief Financial Officer and Acting Chief Operating Officer of IRX.
"This in an exciting time for PCT, with multiple new agreements with cell therapy companies, renewals of engagements, and advances in its services, including the expansion of PCT's Engineering & Innovation Center," said Dr. Robin L. Smith, Chairman and CEO of NeoStem. "We are proud of the work that PCT does to support the cell therapy industry."
About NeoStem, Inc.
NeoStem is a leader in the emerging cellular therapy industry, pursuing the preservation and enhancement of human health globally through the development of cell based therapeutics that prevent, treat or cure disease by repairing and replacing damaged or aged tissue, cells and organs and restoring their normal function. The business includes the development of novel proprietary cell therapy products as well as a revenue-generating contract development and manufacturing service business. This combination has created an organization with unique capabilities for cost effective in-house product development and immediate revenue and cash flow generation. www.neostem.com
About PCT
Progenitor Cell Therapy (PCT), a wholly owned subsidiary of NeoStem, Inc., is a leading contract development and manufacturing organization in the cellular therapy industry. For over 15 years, PCT has provided pre-clinical and clinical cGMP development and manufacturing services to more than 100 clients, advancing regenerative medicine product candidates from the development stage all the way through to human testing. PCT has two cGMP-compliant, state-of-the art facilities in New Jersey and California to serve the cell therapy industry and offers manufacturing of cell therapy-based products, engineering and innovation services, process and product development, cell and tissue processing, collection and storage, regulatory consulting, facility design, validation, and due diligence evaluations. www.pctcelltherapy.com
About IRX Therapeutics
IRX Therapeutics is a privately held company that develops immune therapies to treat cancer and related diseases. The company's therapies are designed to target and restore the immune system in order to improve a patient's response to next-generation cancer vaccines and novel targeted therapeutics. IRX Therapeutics was founded by John W. Hadden, M.D., a pioneer in the field of Immunopharmacology. The company's product platform under development, which is based on over 30 years of research by Dr. Hadden, seeks to restore the immune system of cancer patients, which is suppressed by the onset of the disease. www.irxtherapeutics.com
Forward-Looking Statements
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 ability to consummate the CSC acquisition and the Company's ability to develop and grow its business, the successful development of cellular therapies, including with respect to the Company's research and development and clinical evaluation efforts in connection with the Company's CD34 Cell Program and T Regulatory Cell Program and other cell therapies (including Melapuldencel-T if CSC is successfully acquired), the future of the regenerative medicine industry and the role of stem cells and cellular therapy in that industry and the performance and planned expansion of the Company's 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 13, 2014 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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