License Allows Manufacture and Distribution of Eltrapuldencel-T (NBS20) for Clinical Trial Use
New York, January 20, 2015 — NeoStem, Inc. (NASDAQ:NBS) a leader in the development and manufacturing of cell therapy products and regenerative medicine, announced today that the State of California’s Department of Public Health, Food and Drug Branch has completed its review of NeoStem’s manufacturing and control processes at its Irvine, California cGMP facility for the production of eltrapuldencel-T (also known as NBS20) and has issued NeoStem a manufacturing license permitting NeoStem to manufacture drugs from this facility, including the manufacture of eltrapuldencel-T for clinical trial use. Eltrapuldencel-T is the Company’s patient-specific targeted cancer immunotherapy under investigation for the treatment of Stage IV or recurrent Stage III metastatic melanoma.
“We are pleased to have reached another critical milestone in the development of NBS20. With this step, we remain on track to begin patient enrollment in our pivotal Phase 3 trial, the Intus Study, to evaluate eltrapuldencel-T in metastatic melanoma, during the first quarter of 2015,” said Dr. David J. Mazzo, Chief Executive Officer of NeoStem.
Eltrapuldencel-T is an autologous immunotherapy intended to eliminate cancer-initiating (stem) cells capable of causing disease recurrence and progression. Creation of the therapy begins with cancer-initiating (stem) cells that have been isolated from the patient’s resected tumor sample, enriched and inactivated. These newly created cancer-initiating (stem) cells are then combined with dendritic cells (antigen-presenting immune cells) derived from the patient’s own blood, and granulocyte-macrophage colony stimulating factor (GM-CSF), a natural growth factor that stimulates white blood cells in the body. The product is then introduced back into the patient via a series of subcutaneous injections.
About the Intus Study
The Intus Study is a multi-national, randomized, double-blind Phase 3 clinical trial in which patients will be randomized in a 2:1 ratio to receive either eltrapuldencel-T or a control treatment (autologous mononuclear cells in GM-CSF). An expected 250 enrolled patients throughout the U.S., Canada, Australia and New Zealand will receive weekly injections for three consecutive weeks, and then once monthly for five months. This investigational treatment, planned to be evaluated in the Company’s Phase 3 Intus study, has been granted Orphan Drug and Fast Track designations by the U.S. Food and Drug Administration and will be conducted under a protocol that has been granted Special Protocol Assessment. For more information please visit www.theintusstudy.com
About NeoStem, Inc.
NeoStem is a biopharmaceutical company 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 combination of a rich therapeutics pipeline and externally recognized in-house manufacturing expertise has created an organization with unique capabilities for cost effective and accelerated product development. 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, the Company’s ability to develop and grow its business, the successful development of cellular therapies with respect to the Company’s research and development and clinical evaluation efforts in connection with the Company’s Targeted Immunotherapy Program, Ischemic Repair Program, Immune Modulation Program and other cell therapies, 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 (“SEC”) on March 13, 2014, the Company’s Current Report on Form 8-K filed with the SEC on May 8, 2014 and in the Company’s other 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 of its control.