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Last $2.82 USD
Change Today +0.03 / 1.08%
Volume 264.9K
NBS On Other Exchanges
As of 8:10 PM 05/4/15 All times are local (Market data is delayed by at least 15 minutes).

neostem inc (NBS) Snapshot

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neostem inc (NBS) Details

NeoStem, Inc., a clinical-stage biopharmaceutical company, develops cell based therapeutics in the United States. It is developing NBS20, a targeted cancer immunotherapy product that is in Phase III clinical trials for the treatment of metastatic melanoma; NBS10, a ischemic repair product that is in Phase II clinical trial to preserve heart muscle function following an acute myocardial infarction; and NBS03D, an immune modulation product that is in Phase II clinical trials for the treatment of type 1 diabetes. The company, through its subsidiary, Progenitor Cell Therapy, offers process development and clinical manufacturing services. It is also involved in oncology, cord blood, and adult stem cell processing and banking activities; and the provision of clinical services. NeoStem, Inc. was founded in 1980 and is headquartered in New York, New York.

182 Employees
Last Reported Date: 03/2/15
Founded in 1980

neostem inc (NBS) Top Compensated Officers

Executive Chairman
Total Annual Compensation: $937.4K
Chief Scientific Officer, President of Progen...
Total Annual Compensation: $418.6K
Chief Medical Officer
Total Annual Compensation: $445.2K
Vice President of Strategic Transactions
Total Annual Compensation: $319.6K
Compensation as of Fiscal Year 2014.

neostem inc (NBS) Key Developments

Neostem, Inc. Announces First Patient Randomized in Pivotal Phase 3 Melanoma Immunotherapy Clinical Trial

NeoStem, Inc. announced the randomization of the first patient in the Intus Phase 3 clinical trial investigating the efficacy of the company's patient-specific targeted cancer immunotherapy candidate NBS20 (USAN = eltrapuldencel-T) in patients with stage III recurrent or stage IV metastatic melanoma. The Intus trial has been granted a Special Protocol Assessment (SPA) by the U.S. Food and Drug Administration (FDA), which permits this trial, if successful, to be the sole pivotal trial necessary for registration. The NBS20 development program has also been granted Orphan Drug and Fast Track designations by the FDA. The Intus trial is based on consistent, compelling results from two Phase 2 trials in identical patient populations evaluating the therapeutic vaccine that has become NBS20. The more recent of the two trials was a randomized trial comparing NBS20 to injections of autologous irradiated (inactivated) tumor cells in 42 patients. At two years, survival was 72% compared to 31% for control patients (p=0.007), which was consistent with the previous Phase 2 trial's findings in which NBS20 demonstrated 73% two-year survival in 54 patients, with a median survival of five years. Toxicity was minimal and consisted of mild to moderate local injection site reactions of the type normally associated with injections of GM-CSF (a protein secreted by immune cells that helps stimulate other immune cells to promote immune defenses against disease). The Intus study is a multi-national, randomized, double-blind, placebo-controlled Phase 3 clinical trial in which stage III recurrent or stage IV metastatic melanoma patients will be randomized in a 2:1 ratio to receive either NBS20 (autologous dendritic cells loaded with antigen from self-renewing, proliferating autologous tumor cells in GM-CSF) or a control treatment (peripheral blood mononuclear cells obtained from apheresis product in GM-CSF). The study is expected to randomize 250 eligible patients across approximately 50 sites internationally (US, Canada, Australia, New Zealand and, potentially, select countries of the EU); each patient will receive subcutaneous injections once weekly for three consecutive weeks, and then once monthly for five months. In addition to metastatic melanoma, the platform technology on which NBS20 is based is potentially applicable across multiple solid tumor types, including advanced lung, colon, kidney, ovarian and hepatocellular carcinomas, and glioblastoma multiforme indications that collectively lead to more than 200,000 deaths in the United States each year.

NBS20 of NeoStem, Inc. Receives Advanced Therapeutic Medicinal Product Classification from the European Medicines Agency

NeoStem, Inc. announced that the European Medicines Agency has classified the company's immuno-oncology product candidate, NBS20, as an Advanced Therapeutic Medicinal Product (ATMP). ATMP classification, which is approved by the Committee for Advanced Therapies, 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 by the U.S. Food and Drug Administration. 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.

NeoStem Announces Extension of Study Under Grant From California Institute of Regenerative Medicine (CIRM) to Fund Research of Retinal Disease

NeoStem, Inc. announced the extension of its study under a 2014 Early Translational grant from the California Institute of Regenerative Medicine for research leading to the development of a treatment for retinal diseases, including macular degeneration and retinitis pigmentosa. Under the $4 million grant made to the University of California, Irvine, NeoStem is entitled, through a subaward, to $1 million of new funds adding to the original $0.5 million awarded. The goals of the research are to generate three-dimensional retinal tissue, to investigate the ability of adult induced pluripotent stem cells to restore sight in rodent models of retinal degeneration and to make eventual preparations for clinical use of the tissue. In the first year of the study, NeoStem fulfilled its primary goal of reproducibly generating retinal pigment epithelium (RPE) and layered retinal progenitor tissue, which include progenitors of the major retinal cell types including photoreceptors. This success enables the rest of the study, which will focus on transplantation and testing of these tissues in rodent models of retinal degeneration. Approximately 11 million people in the United States have some form of age-related macular degeneration. This number is expected to double to nearly 22 million by 2050. Estimates of the global cost of visual impairment due to age-related macular degeneration is $343 billion, including $255 billion in direct health care costs.


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