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Neuralstem Announces 2012 Financial Results, Provides Clinical Trials Update
Date:3/15/2013

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Neurogenic Small Molecule NSI-189: Phase I Clinical Trial in Major Depressive Disorder (MDD)

  • The company's lead neurogenic small molecule compound, NSI-189, advanced with FDA approval to treat the second cohort of eight depression patients in the ongoing NSI-189/major depressive disorder (MDD) Phase Ib clinical trial, in October. NSI-189 was shown to be well-tolerated and safe during the 28-day dosing of the first cohort, in the randomized, double-blind, placebo-controlled, multiple-dose escalating trial. The 24-patient Phase Ib commencement was announced in June, with efficacy data blinded for all cohorts until the end of the trial. Neuralstem is expected to complete the entire NSI-189/MDD Phase I trial in the third quarter of 2013. This proprietary new chemical entity increases hippocampal volume and stimulates new neuron growth in the hippocampus, a region of the brain believed to be implicated in MDD, as well as other cognitive and psychological diseases and conditions such as chronic traumatic encephalopathy (CTE), Alzheimer's disease, and post-traumatic stress disorder (PTSD). Data collection includes post-dosing MRIs at both four and eight weeks after completion of the 28-day dosing.
  • In February, the company raised approximately $5.2 million in gross proceeds through an offering of its common stock to fund its ongoing clinical trials and working capital for general corporate purposes.
  • In March, the science journal, "STEM CELLS," published early Neuralstem NSI-566/ALS Phase I interim results, entitled, "Lumbar Intraspinal Injection of Neural Stem Cells in Patients with ALS: Results of a Phase I Trial in 12 Patients." "STEM CELLS" reported that one patient had shown dramatic improvement in his clinical status, and that there was no evidence of accelerated disease progression due to the intervention in any of the 12 patients (who were followed from 6-18 months after injections at this point), nor any l
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