NEW YORK, April 27, 2015 (GLOBE NEWSWIRE) -- NeoStem, Inc. (Nasdaq:NBS), a biopharmaceutical company developing novel cell-based individualized medicine therapies, announced today that the European Medicines Agency (EMA) has classified the Company's lead immuno-oncology product candidate, NBS20, as an Advanced Therapeutic Medicinal Product (ATMP). ATMP classification, which is approved by the Committee for Advanced Therapies (CAT), was established to regulate cell and gene therapy and tissue engineered medicinal products, support development of these products and provide a benchmark for the level of quality compliance for pharmaceutical practices. As a designated ATMP product, NBS20 would follow the Centralized Procedure through the European Medicines Agency and benefit from a single evaluation and authorization process. Additional benefits established through the ATMP regulation include pathways for Scientific Advice and significant fee reductions for such advice.
NBS20 is the Company's patient-specific targeted cancer immunotherapy candidate being investigated in the Intus Phase 3 trial in patients with stage III recurrent or stage IV metastatic melanoma. Treatment of metastatic melanoma continues to be an unmet medical need globally. In Europe, over 20,000 deaths from melanoma were estimated in 2008, approximately twice the number of recent estimates of annual deaths in the US.
NeoStem's global Intus trial has been granted a Special Protocol Assessment (SPA) by the U.S. Food and Drug Administration (FDA). In addition, NBS20 has US Orphan Drug and Fast Track designations by FDA. Patient screening began in the first quarter of 2015 and the Company anticipates the randomization of the first patient in the Intus trial in the second quarter of 2015.
"We thank the EMA for this validation of the technically advanced nature of NBS20 as a therapy for melanoma. The ATMP classification will facilitate discussions with EMA as part of our strategy to seek product registration in the EU," said Dr. David J. Mazzo, Chief Executive Officer of NeoStem. "This designation sets NBS20 apart from the immunologic approaches being developed to treat melanoma based on inhibition of a single target and emphasizes its ability to address the complex and multiple tumor-specific targets found on each patient's metastatic tumors."
About NeoStem, Inc.
NeoStem is a biopharmaceutical company pursuing the preservation and enhancement of human health globally through the development of novel cell based individualized medicine therapeutics that prevent, treat or cure disease. The Company is developing therapies based on three platform technologies (immuno-oncology, ischemic repair and immunomodulation) with a lead, late-stage clinical program for each. The combination of a rich therapeutics pipeline and an externally recognized in-house center for cell therapy process development and manufacturing has created an organization with unique capabilities for accelerated and efficient 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 Immuno-oncology 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 wholly-owned subsidiary and its center of excellence for cell therapy process development, engineering and manufacturing, PCT, as well as its efforts to expand its capabilities into the cell therapy tools market. 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 2, 2015, 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.
CONTACT: NeoStem, Inc. Eric Powers Manager of Communications and Marketing Phone: +1-212-584-4173 Email: firstname.lastname@example.org