Why Neuralstem Inc. Shares Spiked Higher

Editor's Note: A previous version of this article indicated that a phase 2 study of NSI-566 had not yet begun. The Fool regrets the error.

Although we don't believe in timing the market or panicking over market movements, we do like to keep an eye on big changes -- just in case they're material to our investing thesis.

What: Shares of Neuralstem (NYSEMKT: CUR  ) , a clinical-stage biopharmaceutical company focused on treating central nervous system disorders through neural stem-cell therapies, advanced as much as 13% after reporting final phase 1 results utilizing NSI-566 in treating amyotrophic lateral sclerosis.

So what: According to the results, which were published in the Annals of Neurology and included data from the final six patients in the trial since its interim data update, NSI-566, a spinal cord stem-cell therapy, can be used safely in cervical and lumbar spinal-cord segments and didn't accelerate disease progression, with half of all tested patients demonstrating clinical improvement throughout the trial. Neuralstem notes that the drug merits further investigation and also pointed out the possibility that increasing the number of injections could benefit patients. A phase 2 study began in September of 2013. 

Now what: This is obviously encouraging data for Neuralstem, but let's keep in mind that we're talking about a very early stage therapy here with a lot of testing yet to come. This trial was more of a safety confirmation rather than an efficacy-based trial, so the big tests, including simply nailing down the right dosing, are still on the horizon for NSI-566. Also keep in mind that stem-cell therapeutics have a notoriously poor track record at succeeding in trials, which has largely been reflected in Neuralstem's share price over the years. With that in mind, I'd suggest sticking to the sidelines until we have more concrete efficacy data available from a phase 2 study.

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  • Report this Comment On March 17, 2014, at 2:11 PM, MKantzler wrote:

    The good news is that there was no bad/unexpected news or errors/corrections in the published data. The safety outcome of NSI-566 wasn't likely to change from the interim report, nor was the dosage expectation; so, this is more an announcement of publication than anything else, and the surprise is the spike it is producing in the stock price--a profit opportunity, since when the rush wears off, a return to a more moderate, pre-phase-II price level reflecting this trial should occur.

  • Report this Comment On March 17, 2014, at 2:59 PM, biubbamoo wrote:

    According to CUR's press release today, the surgeries for the Phase II ALS Trial are half finished. So far, 9 patients have been treated; six remain to be treated, the last three twice (both cervical and lumbar injections). Interim top line data, probably on Cohorts A & B (2 million and 4 million stem cell dosage) who will have had their 90 day check-ups, will be reported on April 9th by Dr. Eva Feldman, the trial's prinicpal investigator.

    All of the ALS patients in Phase II are limb-onset, rather than bulber onset. Two of the six patients in the last cohort of Phase I were bulbar onset, wich this treatment does not help. Of the remaining four, three showed improvement. Thus there is a lot of interest in the Phse II data that Dr. Feldman will be presenting in three weeks.

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