NeoStem's Lead Immuno-Oncology Product Candidate, NBS20, Receives ATMP Classification From the European Medicines Agency
April 27 2015 - 7:30AM
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
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, 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: epowers@neostem.com
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