A bone marrow harvest. (Photo credit: Wikipedia)
NeoStem has rebounded this week after a Seeking Alpha blog post suggested its AMR-001 stem cell treatment for cardiovascular disease was unlikely to work.
AMR-001, for which NeoStem is now enrolling patients for Phase 2 clinical trial, is an adult stem cell treatment for patients who have suffered a heart attack. Composed of the patient's own bone marrow derived CD34+/CXCR4+ cells, the therapy is designed to treat damaged heart muscle.
The Seeking Alpha post zeroed in on a recent study that showed little functional improvement in heart patients treated with cardiosphere derived stem cells ( CADUCEUS ). While that stem cell treatment was shown to reduce cardiac scar tissue and enhance the growth of healthy heart tissue, it did little to improve overall heart function.
By implication, Seeking Alpha's contributor said, this was bad news for NeoStem's AMR-001. And for a few days, the company's stock took a beating.
"It is difficult to speculate why a non authored Seeking Alpha piece on Caduceus would make a comparison to NeoStem’s cardiovascular cell therapy in development," NeoStem CEO Robin Smith told me this week.
"These cells are completely different from the cells used by NeoStem. It’s comparing apples to oranges. And as such, I think one needs to be careful about using one cell's outcome to predict the failure or success of a different cell type."
The CD34 cell, the therapeutic that NeoStem is currently testing in Phase 2 study, she said, is one of the principal cells that is naturally called upon during any ischemic insult to help protect and repair the vasculature.
"That story is very well documented and it has been reiterated by multiple labs in pre-clinical and clinical models. As well as many randomized double-blinded, controlled human clinical trials that showed a positive signal for efficacy and safety of CD34 cell therapy for ischemic tissue repair. Even those not intentionally studying CD34 cells have shown the relationship between CD34 cell content and clinical outcome in their studies."
Smith pointed to a recent article published in the European Heart Journal: a meta-analysis of 16 studies, in which 1,641 patients where examined to determine the effects of treating patients with intracoronary bone marrow derived cells on the heart's left ventricular function.
The overall assessment showed that “absolute improvement” of left ventricular function was greater in those individuals treated with bone marrow cells as compared to the control group, said Smith.
"Our cell populations, are the CD34/CXCR4 cells from the bone marrow. We give a concentrated dosing of the cells that work along the SDF-1 gradient which release proteins and factors that provide for new blood vessel growth and improve oxygenation to the damaged tissue in an attempt to prevent adverse consequences that result from a heart attack."
NeoStem does not manipulate or expand these cells and they are autologous so there is no risk of immune rejection by the patient, she added.
As for AMR-001's progress: "We're on track to complete enrollment in the Phase 2 trial this year," said Smith. "And we expect data 6 to 8 months after the last patient is enrolled. On September 6th, we announced that 131 patients of the 160 patients had already been infused so we are on track and looking forward to seeing results. "
So, after a volatile week, NeoStem's stock is back on an upward trend.
Henry McCusker at Scimitar's Regenerative Medicine Investors offered some thoughts on the situation.
"As you know, the Seeking Alpha article was published on 9/16," he told me in an email today. "The day before the article, NeoStem (NBS) closed at $9.25. On publish day, volume doubled from 714K the day before to 1.5M and closing price was $8.27, nearly a $1.00 drop.
"Over the following week volume returned to normal levels and pricing fluctuated within a $1.00 range. NBS closed yesterday at $9.03. So overall net loss from over the last 10 days was -$0.22 or -2.1%."
What's interesting to note, he added, is that NBS is still up +17.5% since the beginning of the month (9/3 close: $7.45).
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