Anavex Life Sciences Corp (AVXL)

[falconer66a]

Cognition Improvement Never Demonstrated Before, Nor Cognition Maintenance.

In previous trials, has anyone improved from baseline or even held baseline for more than a couple months?

Important question.

No, none of the existing four drugs FDA-approved for treatment of Alzheimer's has ever demonstrated strong or enduring restoration or increase of cognition. Their benefits are always mild, and do not endure. After a short period, a few weeks to a few months of stabilized or slightly improved symptoms, the drugs loose effects and the disease resumes its progression to the inevitable lethal terminus.

Some might claim there are unapproved, new drugs still in laboratories that might be Anavex 2-73 competitors. If so, no one has heard much of a peep about them. There have been no illustrative trials or results comparable to the Anavex Australian study, where, indeed, Alzheimer's patients had their symptoms at least stabilize (not get worse), or even decline, with restored, normalized cognitive functions.

And therein are the crucial factors for FDA approval of Anavex 2-73 for Alzheimer's. Simply, two factors must prove favorable. A), the drug must prove to be safe, without debilitating side effects. None were found in the Australian Alzheimer's patients taking Anavex 2-73. And lab rodents have been exhaustively tested for side effects. None have ever appeared to a level that would disqualify for FDA approval. In Anavex-treated humans, in a few, the worst were incidental (but tolerable) episodes of headache and upset stomach --- probably only at high edge-of-tolerance dosages.

B), the drug has to show better-then-now symptomatic results. The drug has to exceed a record of treatment of the existing Alzheimer's drugs, the so-called Standard of Care. Because none of the four existing Alzheimer's drugs provide strong or lasting symptomatic relief, this will be a low hurdle for Anavex 2-73 to leap. Indications from the Phase 1 trial in Australia predict and portend similar enduring and progressing wide-spectrum results in the up-coming big double-blind Phase 3 Anavex-against-Alzheimer's trial starting some time this fall, for 52 weeks.