• "Most men would rather deny a hard truth than face it"

    - George R.R. Martin, Game of Thrones

Posted: May 27th, 2014

Washington is roiling this week with calls for the resignation of General Shinseki, the Secretary of the Veterans Affairs, amid new allegations that VA facilities covered up long patient wait times for veterans. It will be a national disgrace if General Shinseki is forced to resign, and would only provide further proof that our society would rather deny hard truths than face them. In many ways the dispute over treatment options for veterans is too little too late. The search for scapegoats has, as it almost always does, led us away from looking at the real causes of year-long wait times for appointments and years-long appeals.

Veteran care is an area of increasing importance to Neuralstem as a company. Not only do we hope to help patients with heretofore untreatable spinal cord injuries and brain trauma injuries with our stem cell therapies, but our small molecule drug to treat MDD is now progressing with great promise. Our future is now inextricably linked to the VA system for the treatment of these ailments in veterans.

Soldiers returning to civilian life often feel that the entire VA system is adversarial in nature. And, unfortunately, this has too often proven to be the case. The hard truth is that the current system rations care to our veterans. We insist that there should be no limits to our gratitude for their service, but we send people to Congress who insist on cutting resources. Soldiers and veterans are used as nothing more than political pawns in their "bigger" fight for budget and tax priorities. This system pits the active service against the VA in the end, as each tries to preserve their "piece of the pie" for what they believe is their core mission, and seeks to shift costs where ever possible to the other. The problems that these turf wars have created over the past 50 years in Washington are now coming home to roost.

General Shinseki has actually loosened and simplified the process for applying for claims, and greatly enlarged the pool of eligible vets. For instance, soldiers from the Vietnam era are now covered for Agent Orange mediated problems. This was a bold and meaningful effort to make the system less adversarial for those soldiers. But like all agencies, the VA is overworked and under resourced, and one result of this was an increase in the backlog of cases measuring in the hundreds of thousands. By all accounts they have cut into that backlog substantially. However, each time the VA drops a barrier to claims, the backlog inevitably increased again. So each time they “help” solve one problem, they exacerbate another.

There is no high ground in this argument; every side is guilty of contributing to the problems, and none have proposed anything to substantially change things. General Shinseki on the other hand has done just that; he has changed the "facts on the ground" by allowing more claims and making submitting claims a more user-friendly process. Although this has created a short term problem of increased demand without an increased ability to respond, the issue will be resolved eventually, and in the end General Shinseki will have been one of the few people to actually make an impact.

Neuralstem hopes also to make a substantial difference in veteran care. The abstract for the results of our Phase Ib trial in Major Depressive Disorder (MDD) recently became publicly available. This is our first in class neurogenic drug (a small molecule, orally active drug, a pill). We believe that this drug works by structurally rebuilding the hippocampus, repairing the atrophy that we see in MRI's in depressed patients. The specific data is still embargoed until June 17th when it will be presented by Dr. Marlene Freeman, Medical Director, Clinical Trials Network and Institute, Massachusetts General Hospital, and Associate Professor of Psychiatry, Harvard Medical School, at the American Society of Clinical Psychopharmacology Annual Meeting. But as the abstract states unequivocally, the patients in this double blind placebo controlled trial showed clinically meaningful improvement across every test given to them; and that improvement persisted for months after the dosing stopped. Some of you have asked about the use of the term “clinically meaningful" compared to the more frequently used term “statistically significant.” Clinically meaningful is a much higher standard. Of course we have statistical significance, but that alone doesn't mean that the improvement is enough to make a difference to the patients. Clinically meaningful means exactly that.

This is an entirely new class of drugs with new mechanisms of actions and, as the abstract says, also improved the cognitive impacts associated with MDD. We believe that NSI-189 will eventually be used to treat a wide range psychiatric indications and ultimately cognitive indications such as pre-Alzheimer’s dementia and Alzheimer’s.

We are looking forward to June 17th when we can share the data from this trial beyond the abstract and the following week when the biomarker data from the trial is made public at the 29th Annual CINP World Congress of Neuropsychopharmacology on June 24th. At Neuralstem, we are extremely proud that our technology is being turned to issues that affect so many active duty soldiers and Veterans.

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