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Wednesday
Jan252012

NeoStem's ($NBS) First Patient is Enrolled in Amorcyte Trial

Wow, what a long way NeoStem (NYSE AMEX: NBS) has come. In the past year this company has been transformed from one focused on pre-clinical VSEL's which hold promise of being a naturally pluripotent adult stem cell to a Phase II clinical company with a well-designed, well vetted therapy (CD34+/CXCR4+ Cell derived from a patient’s own bone marrow) for the preservation of Heart function. The name of the trial is PreServe!

From the press release:

"The study is a multicenter, randomized, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of infarct-related artery infusion of AMR-001, an autologous bone marrow derived cell therapy enriched for CD34+ cells. AMR-001 is administered 5 to 11 days post-stent placement in patients diagnosed with an ST segment elevation myocardial infarction with ejection fraction less than or equal to 48%, as determined by cardiac magnetic resonance imaging."

This is a critical element of the NeoStem story. Unlike most of the other companies who are also working in the heart attack space, NeoStem is based on their understanding of the underlying biology of heart attacks. It typically takes 5-6 days for the ischemic signal from the healthy but overworked myocytes (heart cells) that surround the infarct tissue to build up to a point where the CD34 cells can migrate locally via their cell receptor (CXCR4). They then modulate the process of angiogenesis where it’s needed.

In other words, if you give cells too soon, it becomes cellular Advil (calming down inflammation) but not really modulating the localized needs around the peri-infarct zone, and if you give cells too late, the myocytes are not rescued. This is the only cell therapy company we are aware of that has been so explicit with their understanding of the active cell type (it’s not a gamish of stem cells, its CD 34+ cells), delivered at a specific dose, at a specific time.

Conclusion: Look for news from NeoStem on this trial which has the potential to transform the way heart attacks are treated. This will take 12 months to complete enrollment with data 6 months after last patient is treated. Also keep an eye out for the company to divest their 51% ownership in the China Generics company. This should be a welcome event by The Street that could unlock significant shareholder value.

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« Cytori (CYTX) : FDA Green Lights the Start of a Trial based on an IDE | Main | Today, January 25, 2011, NeoStem Senior Management, Subsidiaries Invited to Speak at Seventh International Conference on Cell Therapy for Cardiovascular Disease; $NBS »