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Posted On: 11/02/2017 7:40:22 PM
Post# of 1460
Post copied from IHUB,
Fletch
falconer66a Thursday, 11/02/17 06:29:27 PM
Re: None
Post # of 127988
Anavex 2-73 and Prodromal Alzheimer’s
The upcoming Phase 3 clinical trial of Anavex 2-73 is targeted, conventionally, at mid- to mild-case Alzheimer’s patients. These people are in decline, have Alzheimer’s symptoms that preclude normal living patterns and functions: cognitive deficiencies, etc. There will be no doubt that the drug is being tested on people who actually have the disease. Should (as expected) the drug terminate cognitive decline, holding things at the level at the start of the trial, or even increase cognition abilities, the drug will be approved by the FDA.
The Phase 1 / 2 safety and tolerability study In Australia established a very favorable safety profile, with all of the adverse events (few) at only Levels 1 and 2.
If the new, much bigger study replicates the outcomes of the Australian study, FDA approval shall occur, inasmuch as the existing Standards of Care, the four drugs presently approved for Alzheimer’s, have never approached the favorable therapeutics of Anavex 2-73. None of them stabilize or improve cognition; they merely slow its decline for a short period.
All well and good. Anavex 2-73 is very likely to gain FDA approval. But that’s not the real story. I contend the Big Anavex Story will be with people with prodromal Alzheimer’s, people who have just the first symptoms of the disease, when it first begins.
I’m familiar with this, as my father suffered and died from Alzheimer’s (and was a clinical participant for one of the four Alzheimer’s drugs, during their clinical trials, resulting in its FDA approval). We watched my formerly intelligent father, an accomplished tax accountant, slowly lose his ability to think and recall recent events. My mother was a practicing geriatric nurse, and knew from the start, at the prodromal stage, what was happening and how it would lethally end.
That will be the Big Anavex Story. Once approved, Anavex 2-73 will be prescribed at the very first indications of Alzheimer’s onset, at the “prodromal” stage. With this, the drug is likely to be far more successful in suppressing and/or reversing symptoms than in the Phase 3 clinical trial. Those people will have had the disease with the symptoms well-established and rather severe, when it may be harder to control or reverse.
Let’s imagine that Anavex 2-73 efficacy gets established for only about half of the people in the new Phase 3 study. Inasmuch as no present care motif can achieve that, it will be approved. But in practice, when prescribed for prodromal Alzheimer’s cases, efficacies will almost surely be much greater — 100%?
The medical, social, and financial benefits of Anavex 2-73, against just Alzheimer’s, are yet unrealized, not even fully anticipated.
I’ve not stated this before. Pending the Phase 3 results, Anavex 2-73 may have the potential to elevate appropriate parties into Noble Prize contention. Let’s watch.
[This author advises that his postings should not be used to prompt any AVXL buy or sell decision. Anavex Life Sciences Corp is presently a small, no-revenues, no-product start up pharmaceutical. It may have a great future, as its science is unique and effective. But, of course, never put at risk any non-discretionary funds.]
Fletch
falconer66a Thursday, 11/02/17 06:29:27 PM
Re: None
Post # of 127988
Anavex 2-73 and Prodromal Alzheimer’s
The upcoming Phase 3 clinical trial of Anavex 2-73 is targeted, conventionally, at mid- to mild-case Alzheimer’s patients. These people are in decline, have Alzheimer’s symptoms that preclude normal living patterns and functions: cognitive deficiencies, etc. There will be no doubt that the drug is being tested on people who actually have the disease. Should (as expected) the drug terminate cognitive decline, holding things at the level at the start of the trial, or even increase cognition abilities, the drug will be approved by the FDA.
The Phase 1 / 2 safety and tolerability study In Australia established a very favorable safety profile, with all of the adverse events (few) at only Levels 1 and 2.
If the new, much bigger study replicates the outcomes of the Australian study, FDA approval shall occur, inasmuch as the existing Standards of Care, the four drugs presently approved for Alzheimer’s, have never approached the favorable therapeutics of Anavex 2-73. None of them stabilize or improve cognition; they merely slow its decline for a short period.
All well and good. Anavex 2-73 is very likely to gain FDA approval. But that’s not the real story. I contend the Big Anavex Story will be with people with prodromal Alzheimer’s, people who have just the first symptoms of the disease, when it first begins.
I’m familiar with this, as my father suffered and died from Alzheimer’s (and was a clinical participant for one of the four Alzheimer’s drugs, during their clinical trials, resulting in its FDA approval). We watched my formerly intelligent father, an accomplished tax accountant, slowly lose his ability to think and recall recent events. My mother was a practicing geriatric nurse, and knew from the start, at the prodromal stage, what was happening and how it would lethally end.
That will be the Big Anavex Story. Once approved, Anavex 2-73 will be prescribed at the very first indications of Alzheimer’s onset, at the “prodromal” stage. With this, the drug is likely to be far more successful in suppressing and/or reversing symptoms than in the Phase 3 clinical trial. Those people will have had the disease with the symptoms well-established and rather severe, when it may be harder to control or reverse.
Let’s imagine that Anavex 2-73 efficacy gets established for only about half of the people in the new Phase 3 study. Inasmuch as no present care motif can achieve that, it will be approved. But in practice, when prescribed for prodromal Alzheimer’s cases, efficacies will almost surely be much greater — 100%?
The medical, social, and financial benefits of Anavex 2-73, against just Alzheimer’s, are yet unrealized, not even fully anticipated.
I’ve not stated this before. Pending the Phase 3 results, Anavex 2-73 may have the potential to elevate appropriate parties into Noble Prize contention. Let’s watch.
[This author advises that his postings should not be used to prompt any AVXL buy or sell decision. Anavex Life Sciences Corp is presently a small, no-revenues, no-product start up pharmaceutical. It may have a great future, as its science is unique and effective. But, of course, never put at risk any non-discretionary funds.]
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