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January 10, 2014
08:05 EDTSTEMStemCells expands Phase I/II spinal cord injury trial to North America
StemCells announced that a team at the University of Calgary successfully transplanted its first subject in the company's Phase I/II clinical trial in chronic spinal cord injury, with the company's proprietary HuCNS-SC human neural stem cells. The ninth subject to enroll in the trial, which was initiated in Switzerland, is the first spinal cord injury patient to have undergone transplantation in North America. This expansion from a single-site, single-country study to a multi-site, multi-country program accelerates the current trial, which should complete enrollment of the remaining three patients this quarter, and pave the way for a controlled Phase II efficacy study that StemCells, Inc. plans to initiate mid-year to further investigate its HuCNS-SC product candidate as a treatment for spinal cord injury.
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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