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August 2, 2013
09:13 EDTSTEMStemCells presents two-year PMD data
StemCells presented data which show that two years after transplantation of the company's proprietary HuCNS-SC cells into patients with Pelizaeus-Merzbacher disease, or PMD, the evidence of myelination, by MRI, is more pronounced compared to one year post-transplantation, the gains in neurological function reported after one year were maintained, and there were no safety concerns. Patients with PMD have a defective gene which leads to insufficient myelin in the brain, resulting in progressive loss of neurological function and death. The neurological and MRI changes suggest a departure from the natural history of the disease and may represent signals of a clinical effect. In the Company's Phase I trial, which was conducted at the University of California, San Francisco, four patients with connatal PMD, the most severe form of the disease, were enrolled and transplanted with HuCNS-SC cells. The patients were followed for twelve months after transplantation, during which time they underwent intensive neurological assessments and magnetic resonance imaging at regular intervals. The Phase I trial results indicate a favorable safety profile for the HuCNS-SC cells and the transplantation procedure. Analysis of the MRI data showed changes consistent with increased myelination in the region of the transplantation, which progressed over time and persisted after the withdrawal of immunosuppression at nine months. The results support the conclusion of durable cell engraftment and donor cell-derived myelin in the transplanted patients' brains.
News For STEM From The Last 14 Days
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November 24, 2015
07:17 EDTSTEMStemCells coverage assumed with a Buy at H.C. Wainwright
H.C. Wainwright analyst Yi Chen assume coverage on StemCells with a Buy rating and $2.10 price target.
November 19, 2015
09:16 EDTSTEMOn The Fly: Pre-market Movers
UP AFTER EARNINGS: Keurig Green Mountain (GMCR), up 19%... (CTRP), up 11.8%... (CRM), up 5.4%... Perry Ellis (PERY), up 4%. ALSO HIGHER: Celladon (CLDN), up 55.9% after signing a merger agreement with Eiger BioPharmaceuticals... StemCells (STEM), up 45.7% after Phase II Pathway Study data shows motor improvement in SCI patients... UniPixel (UNXL), up 36.1% after receiving an initial mass production order from a Japanese PC manufacturer... Anavex Life Sciences (AVXL), up 16% after announcing preparation of regulatory filings based on guidance from FDA... Plug Power (PLUG), up 3.7% after securing Colruyt Group as its next GenDrive fuel cell customer in Europe. DOWN AFTER EARNINGS: Stage Stores (SSI), down 14.7%... JinkoSolar (JKS), down 7.5%... Best Buy (BBY), down 5.2%... Semtech (SMTC), down 7.5%. ALSO LOWER: AMAG Pharmaceuticals (AMAG), down 8.4% after receiving a complete response letter from the FDA its application seeking approval for a single-dose vial of Makena... Titan International (TWI), down 8.3% after being downgraded to Sell from Neutral at Goldman... Sunedison (SUNE), down 5.5% after Reuters reported that Blackstone (BX) is not interested in SunEdison investment.
November 18, 2015
16:09 EDTSTEMStemCells Phase II Pathway Study data shows motor improvement in SCI patients
StemCells announced that the six-month interim results for the first cohort in its ongoing Phase II Pathway Study in cervical spinal cord injury, or SCI, showed motor improvements in both strength and function. The assessment of motor function involved using tests of dexterity. Patients eligible for the study have complete loss of motor control below the level of injury, the most severe degree of SCI as defined by the American Spinal Injury Association Impairment Scale, or AIS. Clinicians used both ISNCSCI, or International Standards for Neurological Classification of Spinal Cord Injury, and GRASSP, or Graded Assessment of Strength Sensibility and Prehension, measures to establish a pre-transplant baseline for each patient and to assess post-transplant progress. This first cohort of the Pathway Study was designed to assess the safety, and preliminary signs of efficacy, of cell administration into the cervical cord and select the dose level for the 40-patient second cohort, a randomized, controlled and single-blinded arm of the trial, which is already underway. Based on six-month follow-up, for the first cohort, an overall pattern of motor improvement was detected in four of the six patients as measured by gains in both strength and function on the collective ISNCSCI and GRASSP outcomes.
November 12, 2015
11:12 EDTSTEMStemCells to hold a conference call
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