Copy
NeoStem Receives Drug Manufacture License for Irvine Facility

NeoStem Receives Drug Manufacture License for Irvine Facility

License Allows Manufacture and Distribution
of Eltrapuldencel-T (NBS20) for Clinical Trial Use



NEW YORK, Jan. 22, 2015 (GLOBE NEWSWIRE) -- NeoStem, Inc. (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

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 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.


Media Contact:
NeoStem, Inc.
Eric Powers
Manager of Communications and Marketing
Phone: +1-212-584-4173
Email: epowers@neostem.com


 

Download Investor Presentation and Corporate Profile

              
About SWI
SWI is a leading edge pr and information marketing service with a highly frequented web site www.stockwatchindex.com and its "Rise Above The Noise" newsletter, which informs you about new and promising discoveries. The weekly "SWI QuickPicks" Ratings Report keeps you informed about newly initiated stocks and potential upgrades and downgrades in the QuickPicks section on our SWI website. SWI QuickPicks represent the consolidated opinions of carefully selected financial analyst blogs and opinions of Wall Street firms that we respect and frequently sample. We  have not been compensated by the companies and do not necessarily hold positions in any of these stocks.  You can conveniently follow the live links for each stock on http://www.stockwatchindex.com/swi-quickpicks/ for more detail.  SWI's periodical "Portfolio Performance Report" reports on the performance of the stocks that we have purchased and are holding in the SWI portfolio.  Please do not miss the wealth of frequently updated news, research reports and other valuable information elsewhere on SWI, especially for the stocks on our WatchIndex page. Watch a full range of CEO and analyst interviews on our Strategic Partner site www.wideworldofstocks.com.
Facebook
Twitter
LinkedIn
Google +
StockWatchIndex
SWI Investment Criteria
We do not necessarily present stocks for "day-trading-profits", although following our news could create the opportunity to do so. Our recommendations are never solely based on the day's or week's performance, or on an anticipated awareness campaign. They are based on current and past performance, analysis of the current and projected financial position, as well as the expectation that we have for the general performance of the Company going forward. Actual results always depend on the timely implementation of the company's business plan. SWI picks companies at an early stage of their development that it (and other credible analysts) believe have a solid core business model and good potential for success. This service for our subscribers is meant to convey a "quick" reflection of the market mood for certain stocks, which may inspire you to depart on your own research. We disclose in the individual stock and/or analyst reports if any of the companies or third parties may have compensated us for distributing the information about their companies. Do not solely rely on the opinions expressed in this publication, always talk to your personal investment adviser before making an investment decision. Be aware that investing into penny stocks represents a high risk investment and you can potentially loose your entire investment.
 
Good luck and please pass this newsletter on to a friend
to continue building our community.
 

StockWatchIndex (SWI) is not a registered investment adviser and makes no warranty, expressed or implied, as to the accuracy or completeness or fitness for a purpose (investment or otherwise), of the information provided in the publications for its Stock Watch List or on its web sites. The provided information is not to be construed as personal financial advice, or a solicitation to buy or sell stock. Some information has been generated by what SWI deems to be reliable third party entities, but SWI does not guarantee the accuracy, timeliness, completeness or correct sequencing of the information, or  warrant any results from use of the information. We have contracted with (NBS) and some of the other companies we represent as public relations consultants to keep the market and especially our subscribers informed about the company and are being compensated in cash and/or stock and stock options. Readers are encouraged to consult their personal financial adviser before making any decisions to buy, sell or hold any securities mentioned herein. StockWatchIndex is not responsible for any error, mistake or shortcoming that may be occasioned at the time of publishing of the information in its Stock Watch List or on its web sites. No liability is accepted by StockWatchIndex whatsoever for any direct, indirect or consequential loss arising from the use of the information. StockWatchIndex expressly disclaims any fiduciary responsibility or liability for any consequences, financial or otherwise arising from any reliance placed on the information provided. The included information is subject to change without notice..

Copyright © 2015 StockWatchIndex, LLC, All rights reserved.


unsubscribe from this list    update subscription preferences 

Email Marketing Powered by Mailchimp