Positive Stem Cells Safety Profile (STEM, GERN, NBS, OPXA)
StemCells, Inc. (NASDAQ: STEM) has created some interest in the stem cell sector again on some important safety news. While today’s news is best for StemCells, Inc. (NASDAQ: STEM) as a company, this will only act to highlight others involved in stem cell research. We are also seeing moves in Geron Corporation (NASDAQ: GERN), Neostem, Inc. (AMEX: NBS), and Opexa Therapeutics, Inc. (NASDAQ: OPXA).
The company (StemCells) announced that Nathan Selden (M.D., Ph.D., F.A.C.S., F.A.A.P.) is presenting a feature presentation today at the American Association of Neurological Surgeons 2010 Annual Meeting. This is said to be one of the leading forums for neurosurgeons from around the world to present and discuss cutting-edge research in the field.
Dr. Selden was co-principal investigator of StemCells’ Phase I clinical trial in neuronal ceroid lipofuscinosis (Batten disease), a fatal neurodegenerative disorder in children, where he presents the positive safety data from the trial and will note that additional data from the ongoing long-term follow-up study continue to affirm the safety profile of the Company’s HuCNS-SC cells. He notes, …“Initial results regarding safety associated with the transplantation of a significant cell dose are certainly promising. Further investigation of HuCNS-SC cells is warranted for infantile and late-infantile NCL, as well as for exploring this cell therapy approach for other conditions of the central nervous system.”
The Phase I NCL trial was the first ever FDA-authorized clinical trial to use purified human neural stem cells as a potential therapeutic agent. That study was designed primarily to evaluate the safety of the Company’s HuCNS-SC product candidate. The trial was completed in January 2009, and the results were submitted to the FDA in September 2009. The results are that the trial data demonstrated that the HuCNS-SC cells, the transplantation procedure, and the immunosuppression regimen were all well tolerated, and that the patients’ medical, neurological and neuropsychological conditions, following transplantation, appeared consistent with the normal course of the disease. A total of six patients in advanced stages of either infantile or late infantile NCL were enrolled and treated in the trial. One patient succumbed to the disease approximately 11 months post-transplant. The company further noted:
- The five patients who completed the 12-month evaluation period prescribed in the trial protocol were subsequently enrolled in a separate four-year observational study. Thus far, data from this ongoing follow-up study show no evidence of serious adverse reactions directly associated with the HuCNS-SC cells or other safety concerns associated with the stem cell treatment. All five patients survived at least two years after being transplanted with HuCNS-SC cells, and magnetic resonance imaging (MRI) at the two-year post-transplant point reveal no signs of cyst or tumor formation. Two patients passed away at approximately 2.5 years and 3.4 years post-transplant, respectively, and these deaths are also believed to be due to progression of the underlying disease. The three surviving patients are now approximately 2.3 years, 2.7 years, and 3.0 years post-transplant, respectively. StemCells recently submitted a protocol to the FDA for initiation of a second clinical trial of its HuCNS-SC cells in NCL.
Further information:
- no evidence of adverse reactions directly associated with the HuCNS-SC cells or other safety concerns associated with the stem cell treatment
- four-year observational study of patients that were treated in first ever FDA-authorized clinical trial to use purified human neural stem cells as a potential therapeutic agent
- “Remarkable” safety findings considering up to 1 billion cells were transplanted in each of the patients promising indication of the long-term safety
As with all “Safety Profiles,” investors do need to consider that a safety profile often has very little do with the overall efficacy of the products. StemCells Inc. (NASDAQ: STEM) is up 3.5% or $0.04 at $1.20 on this news. Not massive, but far from piddly. That being said, the following stem cell stocks are on the move today:
- Geron Corporation (NASDAQ: GERN) $6.06 +$0.23 +4.0%
- Neostem, Inc. (AMEX: NBS) $2.61 +$0.18 +7.4%
- Opexa Therapeutics, Inc. (NASDAQ: OPXA) $2.41 +$0.16 +7.1%
JON C. OGG
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