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Expert Financial Analysis and Reporting

Neuralstem: Encouraging Phase 1b Data on NSI-189 (CUR, Buy, $4.35, Free content)

On June 17 at the American Society of Clinical Psychopharmacology Neuralstem reported phase 1b data for its small molecule drug NSI-189 in a randomized double blind trial in depression. This involved 6 patients on placebo and 6 patients on each of three different dosing regimens for a total of 24 patients. The study ran for 28 days and patients were followed until day 84.

NSI-189 has what is believed to be a novel mechanism of action. In animal studies, NSI-189 resulted in a 20% increase in hippocampal volume. This leads to the hypothesis that it achieves its anti-depressant effect from the regrowth of neurons. This is in sharp contrast to current drugs that work through changing the concentrations of neurotransmitters.

A large effect was seen in all four scales employed in the study that are commonly used to assess clinical levels of depression and improvement: CGI-I (Clinical Global Impression Improvement); MADRS (Montgomery-Asberg Depression Scale); SDQ (Symptoms of Depression Questionnaire) and CPFQ (Massachusetts General Cognitive and Physical Functioning Questionnaire). In particular, the Symptoms of Depression Questionnaire (SDQ) showed 0.02 p value at day 28 of dosing, with large effect size (Cohen’s d = 0.90), and 0.03 p value at day 84, 8 weeks after cessation of drug administration, also with large effect size (Cohen’s d = 1.10). Also in cognitive testing, measured by the CPFQ, the study recorded 0.01 p value with large effect size (Cohen’s d = 0.94) at day 28 and 0.01 p value also with large effect size (Cohen’s d = 1.20) at day 84, 8 weeks after cessation of drug administration. Effect size is a statistical term measuring the overall effect of the treatment. A value above .80 is considered to be a large effect.

The safety profile looked quite good.

I am writing this note simply to alert readers to the results. They appear to be quite impressive and could add a second major leg to the CUR investment story. However, this is my first quick look at the data and I will need to spend a lot more time studying it. I will put out a more detailed note later. This appears to be a significant new positive in the story

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  1. They achieved statistical significant results in a relatively small number of patients , which is very encouraging news. Cognitive improvement may suggest additional clinical uses. And most notably, three clinical effects persisted throughout the two-month follow-up period.

    The only thing we don’t know now is whether NSI 189 increases hippocampus volume or helps neuron synaptogenesis. I hope after 29th Annual CINP World Congress of Neuropsychopharmacology on June 24th, the company could release more data.

  2. Great comments as usual.This is a better summary than mine. I will be digging into the data today and will try to get a report out today, but it will probably take longer.

  3. Dud you listen to Mr. Gaar’s Rodman presentation yesterday? I would love to read your observations. I was encourage by his statements:
    1) that the 3 phase I ALS patients are still maintaining the same trend line 1,200 days out. This is new info. Previously we just had that graph up to around 700 days:.
    2) that they are gearing up to treat up to 70,000 stroke patients on an annual basis in China.


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