Anavex Life Sciences Corp (AVXL)

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AAIC Clinical Trials and New Alzheimer’s Drugs Report

An article on the 2017 Alzheimer’ Association International Conference (AAIC) in London states, “Twenty-seven Alzheimer's drugs in Phase III clinical trials and eight drugs in Phase II clinical trials may launch in the next five years,....”

https://www.eurekalert.org/pub_releases/2017-07/apa-2pi071417.php

Note these comments:

There are currently 23 drugs in Phase II and III trials targeting amyloid protein buildup in the brain, while 28 drugs are targeting neurotransmitter activity.

A novel treatment for Alzheimer's hasn't received FDA approval since 2003 and regulatory approval in Europe since 2002.

No new approaches to Alzheimer’s drugs or treatments since 2002, fifteen years ago. A decade and half without anything new in pharmacologics, after the expenditures of many billions of dollars on research and clinical trials.

Except of course (un-noted in the article text) is the unique Anavex approach. I won’t deliberate at any length here on exactly how the Anavex sigma-1 receptor agonist drugs will be safe and effective. That’s been covered repeatedly before in Ihub postings, and will be borne-out in a big, upcoming Phase 3 clinical trial.

Check this projection of the final release and clinical use of new Alzheimer’s drugs:

http://www.usagainstalzheimers.org/sites/default/files/alzheimers-drugs-development-pipeline-2017.pdf?utm_source=RA2Pipeline&utm_medium=PressRelease

Anavex 2-73 is listed, and the projected earliest date (pending, of course, on FDA approval) would be approval in 3rd quarter 2022, with “launch” in 2023.

What can (or should) be made of the copious data on new Alzheimer’s drugs entering Phase 2 and 3 Clinical FDA approval trials? Depends.

Readers already convinced that Anavex 2-73 has a minimal or negative chance of ever having an affirmative Phase 3 clinical trial and will never gain FDA approval might find support in the multitude of perhaps desperate studies to be conducted on a variety of new Alzheimer’s drugs. About 58 or so drugs are listed. If Anavex 2-73 has merely an equal approval chance, it’s got a one-in-58 chance.

Or, Anavex 2-73 is a truly unique and safe and effective treatment of Alzheimer’s symptoms, differing from all the others in diverse ways, particularly in the molecule’s mechanism of action within the neuron, being able to restore normal function (“homeostasis”). Pre-clinical animal studies and the Phase1/2 Australian study in real humans present universally-affirming data as to safety and efficacy.

No one’s perspectives, pro or con, on Anavex 2-73 will be changed by scrutinizing the AAIC report. Those certain of it’s defects will find nothing to change that perspective.

Those of us rather certain of the new drug’s safety, efficacy, eventual FDA approval and global marketing, likewise, will find little to support our very positive perspectives.

Nonetheless, worth at least a skimming read.