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February 12, 2014
08:23 EDTSTEMStemCells finishes enrolling first of two patient cohorts in HuCNS-SC study
StemCells announced that it has completed enrollment of the first of two planned patient cohorts in the company's clinical trial of its proprietary HuCNS-SC product candidate for dry age-related macular degeneration. This cohort consisted of eight subjects, four of whom each received 200K cells and four of whom each received 1M cells. The company said, "Our immediate goal for the study in the next quarter is to complete enrollment of the second cohort. The eight patients in this stage of the trial will have better visual acuity than those in the first cohort. We are expanding the trial from two sites at the beginning to ultimately a total of five sites, and with additional sites actively evaluating patients, the second cohort should be completed by mid-year. We also expect to announce interim follow-up data on the first cohort later this year. Following enrollment of the second cohort, we expect to initiate a controlled phase II efficacy proof-of-concept study by year end."
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.

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