Profile: NeoStem Inc (NBS.OQ)

NBS.OQ on NASDAQ Stock Exchange Capital Market

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29 May 2015
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NeoStem, Inc. (NeoStem), incorporated on September 18, 1980, is a provider of cellular therapy products. The Company is engaged in the development of cell therapy products; it also provides development and manufacturing services. NeoStem’s research and clinical development activities are aimed at three therapeutic platforms: ischemic repair (CD34 Cell Program), immune modulation (T Regulatory Cell Program) and tissue regeneration (VSELTM Technology). The Company develops therapies to address ischemia through its CD34 Cell Program. The Company focuses on the development of cell based therapeutics that prevent, treat or cure disease by repairing and replacing damaged or aged tissue, cells and organs, restoring their normal function. The Company’s AMR-001 is the product candidate in its CD34 Cell Program and is being developed to treat damaged heart muscle following an acute myocardial infarction (heart attack) (AMI).

As of December 31, 2013, the Company completed enrollment in its PreSERVE AMI study. PreSERVE AMI is a randomized, double-blinded and placebo-controlled Phase 2 clinical trial testing AMR-001, an autologous (donor and recipient are the same) adult stem cell product for the treatment of patients with left ventricular dysfunction following acute ST segment elevation myocardial infarction (STEMI). As of September 30, 2014, the Company is also engaged in the development of cellular immunotherapies for cancer, with NBS20, also referred to as DC/TC (dendritic cell/tumor cell), being the lead product candidate in the Company’s immunotherapy pipeline. NBS20 is targeting malignant melanoma initiating cells. This immunotherapy is designed to treat Stage IV or recurrent Stage III metastatic melanoma.

Progenitor Cell Therapy, LLC (PCT), a wholly owned subsidiary of the Company, offers manufacturing services and support to developers of cell-based therapies. PCT has provides pre-clinical and clinical development and manufacturing services. It engages in the development of regenerative medicine product candidates from product inception and standard assessment to human testing, Biologic License Application (BLA) filing and the United States Food and Drug Administration (FDA) product approval. PCT's services for the cellular therapy industry include manufacturing of cell therapy-based products, engineering and innovation services, product and process development, cell and tissue processing, regulatory support, storage, distribution, and delivery and consulting services.

Ischemic Repair (CD34 Cell Program

Through its CD34 Cell Program, the Company is pursuing the development of therapies to address ischemia. Ischemia occurs when the supply of oxygenated blood is restricted in the body. The Company’s product candidate, AMR-001, works by increasing microvascular blood flow in the heart muscle via the development and formation of new blood vessels, thereby reversing the restriction of blood supply caused by a heart attack and rescuing tissue from eventual cell death. The treatment process works on a patient's own bone marrow, which is harvested and a sterile pharmaceutical composition of stem cells found in the bone marrow, enriched for CD34/CXCR4 cells, is prepared. The cell preparation has a 72-hour shelf life. The isolated cells are then infused back into the patient via catheter into the infarct-related artery five to 11 days following an AMI. The cells are attracted to certain chemicals that are released in higher concentrations in oxygen-starved tissue. When they reach the tissue, it begins to orchestrate the process of building new blood vessels to restore blood supply and thereby enhance the function of the damaged heart muscle.

Pre-clinical animal models of induced AMI have demonstrated that CD34/CXCR4 expressing cells migrate naturally to oxygen-deprived locations. More specifically, these cells home to the viable tissue surrounding the infarcted (dead) myocardium, known as the peri-infarct zone. Moreover, CD34/CXCR4 expressing cells have been shown to be capable of inducing the development and formation of new blood vessels over time and preventing heart cell death due to chronic ischemia (chronic ischemia can occur when one's coronary arteries may become so narrowed that they limit the flow of blood to one's heart all the time, even when they are at rest).

As of December 31, 2013, the Company completed patient enrollment in its PreSERVE AMI Phase 2 trial, a multicenter, randomized, double-blind, placebo-controlled the United States clinical trial to evaluate the efficacy and safety of a single intra-coronary infusion of at least 10 million cells of AMR-001, in patients with an acute ST elevation myocardial infarction (STEMI), a particular type of AMI, who are shown to have reduced heart muscle function with ejection fractions of 48% or less as measured by cardiac magnetic resonance imaging (CMR). Under its CD34 Cell Program, NeoStem is conducting pre-clinical studies to determine if a CD34 product exerts a therapeutic effect in an animal model of traumatic brain injury.

Immune Modulation (T Regulatory Cell Program

For the T Regulatory Cell program, the Company is utilizing T Regulatory Cells (Tregs) to treat diseases caused by imbalances in the immune system. In collaboration with Becton-Dickinson and the University of California, San Francisco, the Company is utilizing the technology platform of its subsidiary, Athelos Corporation (Athelos), to restore immune balance by enhancing Treg cell number and function. NeoStem’s pre-clinical assets include VSEL TM (Very Small Embryonic Like) Technology regenerative medicine platform. Other preclinical work with VSELsTM includes exploring macular degeneration as a target indication.

The Company collaborates with Becton-Dickinson and the University of California, San Francisco (UCSF) on the T Regulatory Cell program, using the technology platform of its subsidiary, Athelos Corporation (Athelos), to pursue the development of cell therapies using a person's immune cells as a therapeutic product to treat disorders of the immune system. Many immune-mediated diseases are a result of an imbalance in the immune system whereby inflammatory cells go unchecked. Therapy using T Regulatory Cells (Treg) represents an approach to restoring immune balance by enhancing Treg cell number and function to inhibit pathogenic immune responses.

Tissue Regeneration (VSEL Technology

The Company is focused on the therapeutic potential of very small embryonic-like stem cells, which is referred to as VSELs or VSEL stem cells. The Company has identified cells in human blood and bone marrow that have many of the properties described for murine VSELsTM. This research includes evidence of multipotency and multi-lineage differentiation. These observations provide the groundwork for the development of VSELTM therapies to regenerate or repair damaged or diseased tissues in human subjects.

The Company competes with Cardio3 Biosciences SA, Capricor, Inc., MesoBlast Limited, Athersys, Inc., Pluristem Therapeutics Inc., Cytori Therapeutics, Inc., Lonza Group Ltd. and WuXi AppTec.

Company Address

NeoStem Inc

420 Lexington Ave Rm 350
NEW YORK   NY   10170-0303
P: +1212.5844171
F: +1646.5147787

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