Anavex Life Sciences Corp (AVXL)

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Shall we quibble over dosages, or efficacies?

Granted, Anavex 3-71 dosages in current human trials are orders of magnitude greater than in the therapeutically successful treatment of human Alzheimer's in lab rats.

But the more important matter is that the molecule, in such minute concentrations (micrograms, not milligrams) worked. It didn't just halt the progression of the cognition decline Alzheimer's, it reversed it. Moreover, this restored cognition was retained after the drug was no longer administered. The positive therapeutic outcome persisted after the drug was deleted.

Again, here's the text from the paper, with my typefacing:

Chronic treatment with AF710B [Anavex 3-71] (10 µg/kg) was initiated in postplaque 13-month-old Tg rats. Drug or vehicle was administered orally daily for 4.5 months and interrupted 5 weeks before behavioral testing. Results: AF710B long-term treatment reverted the cognitive deficits associated with advanced Alzheimer-like amyloid neuropathology in Tg rats.

The determination by the FDA to allow sale and therapeutic use of Anavex 3-71 will not hinge on a quibbling over the microgram or milligram dose ranges of the drug; it will be whether or not it WORKS.

In transgenic rats with Alzheimer's the drug a) reversed the progression of Alzheimer's symptoms (cognition decline), and b) retained that enhanced mental facility for an extended period after dosing was terminated.

Frankly, the dosing levels of Anavex 3-71 in any clinical trial, murine or human depends solely on two things; both presently demonstrated in murines: a) is the drug safe; are there any disqualifying "adverse events," side effects? and b) does the drug produce propitious therapeutic outcomes?

Along with the drug's demonstrated safety (in every murine or human trial to date), the reversing of the progression of Alzheimer's, after it has set in, and then retaining that enhanced mental state, will allow the FDA to approve the drug. Both of those will be demonstrated in a proper human trial of Anavex 3-71. Very likely, it will then replace Anavex 3-73 (blarcamesine) as the then SOC, standard of care Alzheimer's drug.