Anavex Life Sciences Corp (AVXL)

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Significance of the OLE.

94%is around 480 Patients enrolled in the OLE.

An explanation.

OLE is “open label extension,” where participants in the Alzheimer’s clinical trial were allowed, if they chose, to continue to take blarcamesine after the trial formally ended. But in this post-clinical period, there was no placebo offered, no starch pills that looked exactly like the blarcamesine pills. “Open label,” meaning that everyone knew with certainty (they could read the label) that in this post-clinical dosing period they were taking the real deal, blarcamesine, not a fool-the-mind placebo.

Of course, one must ponder the reason(s) so many in the Alzheimer’s clinical trial of blarcamesine would elect to continue taking the drug on out, after the clinical trial ended.

First, because blarcamesine (unlike some other Alzheimer’s drugs in development) isn’t taken by infusion (an injection), it’s merely a pill that’s swallowed each day. Continuing with the drug poses no procedural complications. “Hey, it’s breakfast. Gotta take my blarcamesine pill.” So, certainly one factor prompting open label extension participation is the ease of administration.

If that’s the reason, so be it. But I doubt it.

The better explanation is that for the two-thirds of the trial participants, who were in either the 30mg dose or 50mg dose arms, they (or their care-givers) noted distinct and particular good therapeutic outcomes. At the end of the trial they did not wish to discontinue their daily consumption of a blarcamesine pill. They personally liked what it did for them. (Or, at least, their care-givers liked the results; and continued their patients on the drug.)

Of course, a third of the participants were fooled; were in the placebo arm of the trial, where they took a pill each day that looked exactly like the real blarcamesine pills. Obviously, a number of these people, too, elected to use the open extension label opportunity and continue on taking, now, the real pill. That decision had to be based upon hope, not from the placebo’s therapeutic outcomes.

So perhaps a third of the people in the OLE were there only on hope. But the other two-thirds had real reasons, real experiences that prompted them to want to continue to take blarcamesine after the trial ended.

Were they dumb, ignorant, or what? Like us, they have not seen the actual clinical metrics of the blarcamesine/Alzheimer’s clinical study. They were in it, but they’ve seen no clinical data. All they know (better then we) is how the drug affected their individual Alzheimer’s symptoms. Simply, had blarcamesine been only a placebo, with no actual, direct biochemical or physiological involvements in nerves and neurons, how or why would 94% elect to continue to take the drug?