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Current Alzheimer’s Drugs vs. Anavex
Other Agonists? Great, What Are They, Clinical Results?
Important question for potential or existing Anavex equity holders. If there are other sigma-1 receptor agonists equivalent or superior to Anavex 2-73, please post a list of them.
And, please tell of their status in testing against Alzheimer’s and other Central Nervous System diseases.
Can any of these be suppressing competitors of Anavex 2-73. If so, what might be the evidence for this? Are any in current or projected clinical trials?
What are the possibilities that these other sigma-1 receptor agonists might displace Anavex 2-73?
Their mere existence on lab benches in no way affects the validity of Anavex 2-73. They have to be clinically competitive. No evidence for such has thus far been presented.
Help us all out, please.
Keeping the Vulnerable Safe, Of Course
A purpose of public comment boards like this includes keeping the vulnerable from wasting and losing their money on equity investments that will so clearly fail. Anavex is a classic example of this. Among others, here are reasons potential new Anavex investors should turn away from the company, until it gets (if it will) FDA approval for any of its proposed drugs and begins to take in drug sales revenue, making it a functioning pharmaceutical company.
1. Flimsy Efficacy Evidence.
It has been contended by a number of persisting posters here that evidence for efficacy, evidence clearly showing Anavex drugs effectively treat certain Central Nervous System diseases, is utterly lacking; that what little evidence there is from both murine (animal) and human studies is woefully lacking in accuracy and strength. The Anavex story is weak, unsupported by real evidence, and most likely will fail when finally tested in an upcoming big double-blind one-year clinical study against Alzheimer’ disease.
2. Nothing Else Has Worked, So Anavex Can’t, Either.
Any number of Big Pharmaceuticals have spent literally billions of dollars attempting to gain FDA approval of new drugs to effectively treat Alzheimer’s. Alzheimer’s disease is complicated, with any number of root causes. For all of the last and now the present century, not a one of the many new drugs have gained FDA approval or clinical use, with the exception of two or three very ineffective, short-term symptom suppressing drugs. One would be a fool to think a tiny start-up drug company with no approved drugs, no sales, and a minimal staff of just a few employees could possibly accomplish what all of the other mature, multi-billion dollar pharmaceuticals have consistently failed at.
3. Anavex Clinical Data Are Incomplete or Fraudulent.
In Australia, Anavex did conduct an early, small-number clinical safety and tolerability trial. On the face of it, the human results of these small numbers of Alzheimer’s patients were astounding, with corporate claims of rather universal symptom stabilization or actual symptom recession at the end of the study. And, recorded side effects were either absent or very minor. No other equivalent clinical study of any proposed Alzheimer’s drug has ever yielded such positive results.
But, according to those protecting the interests of potential low-information Anavex investors, all of these clinical results data are utterly suspect. First, they can’t be true, inasmuch a nothing like them has ever been seen in any of the several dozen Phase1/Phase2 Alzheimer’s drug tests. The results, simply, shouldn’t be believed. They occurred because of one or more of several reasons: a) per chance, only so-called “super responders,” rare, easy-to-treat subjects, were included in the trial, or, b) the clinical data were either ignorantly or fraudulently “selected” and presented, or, c) the data were accurate, but not reflective of actual results in a larger, more normative population. Lastly, d) the study was not double-blinded. Participants knew they were taking a real, new drug, with great treatment promise. Therefore, intense patient hope, faith, and will power caused the remarkable results, not the drug itself. Classic placebo effects.
4. Anavex Has Hidden Negative Data.
One part of the Australian study was to characterize the pharmacodynamics (effects and changes in body systems) and pharmacokinetics (timing and duration in body systems) of Anavex 2-73. Putatively, these data were taken, but enigmatically have never been released to the public, probably for one real reason: they were bad, indicating that Anavex 2-73 really doesn’t work well against Alzheimer’s disease.
Alternatively, some have contended that the masking of these data is for legitimate corporate collaboration or buy-out negotiations, so as to work very favorable terms for Anavex Life Sciences Corp.
5. Anavex Principals Have Been Given Excessive Equity Positions.
It is contended that the president and other company officials have been granted excessive equity holdings unrelated to their alleged poor performance; that this is the major goal of corporate principals, to take excess salaries and equity holdings during the lengthy start-up period, before events and realities force a cheap external buy-out or outright collapse—all at the expense of unknowing retail equity holders.
6. The Company Retains a Promise of Eventual Success Only Because of the Exuberant Postings of Some Anonymous Lay People on the Internet.
Clearly, the chances of Anavex success are so clearly minimal the company would have already folded, were it not for a good number of exuberant posters on the Internet. These blokes have no particular expertise or knowledge, just an aberrant enthusiasm and verbal eloquence for a hoped-for magical Alzheimer’s cure.
With all of that, new potential Anavex investors have been carefully warned. Keep your funds away from Anavex. When the company folds next year, after all three of the new clinical trials so woefully fail, you will be able to sleep well each night, knowing that you’ve done appropriate due diligence on Anavex Life Sciences Corp. and have saved your funds for more promising, more rewarding investments.
The rest of us, well, imagine just where we will be. Hope we can all congenially talk about it a year from now.
Leading the Witness?
Not the MOA, It’s the Molecule That’s Unique
Yes, the mechanism of action of Anavex 2-73, how it works within the neuron, may not be unique. There may be other sigma-1 receptor angonists. But none of consequence have ever been elaborated upon here by anyone, beyond the Anavex pipeline molecules.
The significance of the Anavex 2-73 mechanism of action in regards to both Central Nervous System patients and to Anavex equity investors (among others) is not that it works in ways like no other, that it has a unique mechanism of action. Instead, it is unique because IT WORKS.
Unless other sigma-1 receptor agonists can match or exceed the demonstrated safety and efficacy profiles of Anavex 2-73 against the various Central Nervous System diseases against which it is targeted, the mechanism of action criticism is a convenient straw man to push or blow over, of no consequence.
The seminal question is not the uniqueness of the Anavex 2-73 mechanism of action whatsoever. Solely, it’s a question of whether or not the drug safely and effectively treats Central Nervous System diseases.
Many of us here, based upon the copious murine and yet-fragmentary human data, coupled with the explanatory mechanism of action (restoration of neuron homeostasis by re-connecting mitochondria and endoplasmic reticula to allow normalized ATP supply and C++ transport and signaling), have the greatest confidence in eventual FDA approval for one or more profound Central Nervous System diseases.
Others are not so convinced, or even entirely skeptical, awaiting confirmatory Phase 3 clinical trials data next year.
The uniqueness of Anavex 2-73's mechanism of action in the treatment or prevention of central nervous system diseases is not an issue of concern whatsoever. Whether or not it safely and efficaciously works is the actual issue. So far, the data point strongly in those two directions. No other drug or molecule has even been hinted to possess equivalent or competitive traits.
If there is one, let’s hear about, regardless of its particular mechanism of action. Right now, there’s only one ball game going on, with Anavex 2-73 on the field. The game rules are the same for all competitors, the restoration of neuron homeostasis by the mechanism of action of re-connecting and restoring mitochondrial and endoplasmic reticular functions. The only balls in play in this game belong to Anavex. Their molecules, are, unique. And they've already racked big scores. This championship came ends later this year or early next, with the box score posting of any of the three human trials soon to commence.
Those of us with AVXL positions will wear our Alzheimer's Treatment Tournament championship rings with pride and delight --- sometimes shaking the hands of CNS disease patients whose lives will have been so much improved or saved.
Just Some Colored Spaghetti?
No offense intended, but the multiplicity of lines and curves, to those of us with no experience with Technical Analysis data plots are utterly undecipherable. We have no idea what the lines mean.
Now I taught the complexities of various intracellular molecular pathways, from the tricarboxylic acid (TCA) cycle, protein synthesis, genetic control of nucleotide sequencing, etc. Those, too, would appear complicated and inscrutable were they posted here.
Glad to have TA experts lending their expertise for our AVXL share price edification.
Now, all I have to do is learn how to read those charts.
Alzheimer’s Progression Sniff Test
A new research report states:
The Anavex 2-73 Patent
Here’s its abstract (summary);
Paper Supports Sigma-2 Receptor Agonists for Parkinson's Disease
Thanks for posting the link. To read the entire article one needs to fork over $35. Saved my dollars, just read the posted abstract; good enough.
In essence, the paper illustrates how restoration of sigma-1 receptor function (exactly what the Anavex sigma-1 receptor agonists do) can restore dopamine levels produced by dopaminergic neurons of the substantia nigra (SN) region of the brain. Disruption of normal dopaminergic functions is the root cause of most Parkinson's disease symptoms. Fix the dopamine deficiency problem in the substantia nigra, and Parkinson's is fixed.
Now Anavex was not mentioned at all in the article. It was not focused on any of the Anavex molecules; instead, it focused on just why neurons in the substantia nigra fail to produce adequate dopamine, causing Parkinson's symptoms. And the reason for that is because dysfunctioning sigma-1 receptors cause death of dopamine-producing neurons. Again, the Anavex molecules restore normal sigma-1 receptor function (they are "agonists," good-condition-promotors).
This paper portends very favorable results in the up-coming 12-week Anavex 2-73 Parkinson's clinical trial.
Just another of many technical papers telling the detailed profound molecular and cytological science of the Anavex molecules.
The Anavex science is solid, as supported, again, by this paper.
About 5 million people in just Western Europe have Parkinson's Disease.
Article Link?
Can you post the link to the article. Very much would like to read this.
Probably No Dose Reduction
Aducanumab is a monoclonal antibody that (putatively) induces the immune system to bind to and remove beta-amyloid deposits.
Its mechanism of action is entirely different from the Anavex sigma-1 receptor agonists. The two can act at the same time (co-administered), but I don't see any reason aducanumab could functionally reduce effective Anavex 2-73 dose sizes. Reduction in aducanumab dosages would almost surely reduce efficacy. The brain swelling adverse event discovered with this drug is a major complication, of course.
Someone who knows more about monoclonal antibodies related to this concept should tell things more definitively, of course.
I noticed that aducanumab has been administered by "monthly intravenous infusions." Anavex 2-73 is dosed very differently, daily, per os, orally.
Having patients required to go and sit in an infusion center once a month is certainly not as favorable as just popping a solid pill while taking breakfast at home each day.
The Whole World, Not Just U.S.
Appropriately, the focus on Anavex drug approvals centers on the USA and the Food and Drug Administration (FDA).
But there is no universal drug approval agency. Each country or union has its own procedures and schedules, varying markedly from the FDA.
Just read an article on this, telling how improved drug approval protocols will be speedy and more cost effective
Anavex Molecules Similar, But Each Must Be Tested
Yes, the Anavex sigma-1 receptor agonist molecules, at least the major ones being used in new human trials (only Anavex 2-73 right now), and later. Anavex 3-71, are apparently very similar.
Regardless, if they are different only by a single hydroxide transposed to a new position (among the many dozens of them) FDA would require separate, individual testing for each form of molecule being proposed for approval.
Most likely, such minor changes would not materially change or affect clinical outcomes. Still, FDA has an obligation to make certain that new, minor re-configurations of the molecule are equally safe and efficacious.
Read typical drug molecule patent application text. First will be the lengthy, detailed chemical description of the molecule, in several forms. Most detailed are the chemical names, and then a graphic representation (molecular or structural model).
The proper, complete chemical name of Anavex 2-73 is tetrahydro-N,N-dimethyl-2,2-diphenyl-3-furanmethanamine hydrochloride.
(Would be fun to say that at a cocktail party, when telling the profound future of Anavex. But, no, I don’t do that. I haven’t memorized it. No good purpose. I’ve memorized the Latin names of several hundred plants and animals I work with professionally. My favorite is Silphium terebinthinaceum. Look it up. Great plant.)
Anavex 3-71 is an enantiomer (specific configuration) of this molecule: (2,8-Dimethyl-1-thia-3,8-diazaspiro[4.5]dec-3-yl)-3-(1Hindol-3-yl)propan-1-one .
Patent drug applications also commonly have text seeking patent protection not only for the specific molecule described and named in the application, but also for any similar molecule that has been chemically modified in minor ways, such as simply moving a hydroxyl (-OH) to another position.
About Anavex for Autism.
Don’t know about this just yet. Because many of the causes of autism occur during cerebral development, at least partially in utero, I’m not certain the Anavex sigma-1 receptor agonists could prevent the neurological mis-connections or malfunctions of the condition. Diagnosis and treatment in utero might be problematic.
But don’t take this conjecture as a “no.” There are a good number of molecules in the Anavex pipeline, with perhaps more to come. I doubt that all have been sufficiently tested in murine models for all of the human diseases that might be treated.
Anavex Life Sciences Corp may eventually have a giant stable of drugs innovatively treating a plethora of diseases and conditions not yet discussed concerning the company. Moreover, as I’ve contended previously, the company many be a great success not only for treatments, but for disease and condition prophylaxis, prevention.
Want No Buyout; Would be a Big Loss
Anavex Molecules are Sigma-1 Receptor Agonists, Not Antagonists
Very interesting and important article. Thanks for posting it. It strongly suggests viable cellular targets to turn off opioid compulsions.
The article tells of the involvement of sigma-1 and sigma-2 receptors in opioid and other psychoactive drug activities within various cells, particularly within the brain.
But the focus is the suggested usefulness (very strong) of sigma-1 or sigma-2 receptor antagonists, new molecules that would disrupt or disable normal sigma receptor functions in the presence of opioids or other drugs.
This is exactly the opposite of what the Anavex molecules do. They are (to my understanding) all agonists, molecules that facilitate or promote normal or restored cellular functions. The target molecules in the article are sigma receptor antagonists, molecules that would disable or suppress normal sigma receptor functions. In the presence of opioids or psychoactive drugs, this would be beneficial.
As far as I know, Anavex doesn’t have any sigma receptor antagonists, only agonists.
But one very important concept was described, the exact parallel of sigma receptors in rats and mice and humans:
Anavex or Missling Numerology?
Pretty interesting parsing of Missling’s 750 share purchase. Whether or not it’s accurate will be seen.
In time, all will be revealed or known.
I’ll Post Any New Science I Find — Little Else
“Release” of “Hidden” Data of No Consequence
Many, for so long, have said that the reason AVXL share prices have declined is simply because the company hasn’t periodically and frequently “released data.”
Now, inasmuch as my contributions here are typically based upon my biological knowledge, not any unique, particular, or useful investment proficiency, this perspective may be incorrect. Let’s see.
I’m contending that even if Anavex Life Sciences Corp started releasing frequent announcements of accumulating information on Anavex 2-73 (whatever hasn’t yet been revealed), and more detailed analyses of the on-going responses of the Australian Alzheimer’s patients, the impact on share price trends would be minimal, at best.
In the case of release of pharmacokinetics/pharmacodynamics data from the Aussie study (yet to occur), I’m betting that, even if positive to the highest degree (supporting biochemistry data that authenticated that everybody got better and stayed better, with no side effects), a positive impact on AVXL shareprices would be moderate and transitory.
Same thing upon the company’s announcement of the initiation of any of the three up-coming clinical trials.
One of my professional interests and participations is closely examining and determining the ethology (animal behavior) of wild raptors (hawks and falcons — hence, my moniker here, as I’ve been a falconer and raptor biologist for many decades). Since taking my first position in Anavex, I’ve delightfully monitored the postings here on the Ihub Anavex board. I notice that there are several populations of posters. A good number are typical retail (personal shareholder) types. A few, are technical analysts, attempting to predict price trends and make propitious trades by arcane interpretations of plotted share price trade data. Then, there is the most difficult to parse population, those who attempt to bring to everyone’s attention every fragment of negative information on either the company and its executives, or the medical science of the Anavex molecules. Putatively, these folks wonderfully are attempting to keep Joe Retail from the big losses that will ensue in any continued or expanded AVXL position.
Therefore, even with the release of the much-discussed hidden information and new corporate releases regarding new trials and the equivalent, the positions of any of the populations of posters here simply will not be changed.
The take-away thought is this. Ain’t nothin’ much gonna happen until positive data emerge from any of the three new clinical trials. With any one of them being a success, upon which the FDA can base a drug authorization, the game does, indeed, change. Anavex will no longer be a pharmaceutical bit player, of no authenticated drug assets.
With anticipated FDA approval of Anavex 2-73, based upon positive new trials results, the entire financial and investment community will be focused on Anavex Life Sciences Corp. The projections of corporate and shareholder successes that I and a few others have posted here will no longer be hypothetical imaginations. Presently, with or without released “data” or corporate “updates,” for most share purchasers, retail or institutional, the Anavex story will remain hypothetical until trials data can support and prompt FDA approval of the drug.
That’s next year sometime. Until then, I’ll be watching the posts on this board, just as I watch the behaviors of wild hawks and falcons — which, with a bit of experience, become rather predictable. Until we get real trials results, I don’t expect much to change here.
Missling Not Selling (Thankfully)
Abstract: The Anavex Presentation
Daniel Klamer, Vice President, Business Development & Scientific Strategy
Anavex Life Sciences
10th CNS PARTNERING & DEAL-MAKING
SEPTEMBER 11-12, 2017 BOSTON, MA
Anavex Life Sciences Corp. (Nasdaq: AVXL) is a publicly traded clinical stage biopharmaceutical company dedicated to the development of differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders. Anavex’s lead candidate, ANAVEX 2-73, is an orally available compound that restores cellular homeostasis by targeting Sigma-1 and muscarinic receptors. ANAVEX 2-73, has demonstrated good safety, bioavailability, and tolerability in Phase 1 and Phase 2 clinical trials. In addition, data from an ongoing Phase 2a clinical trial in Alzheimer’s Disease demonstrates dose dependent cognitive improvements. The compound also exhibits anticonvulsant, anti-amnesic, neuroprotective and anti-depressant properties in animal models, indicating its potential to treat a broad range of CNS disorders.
ANAVEX 2-73 significantly improves multiple behavioral phenotypes in the Rett Syndrome mouse model in a dose-related manner. Based on these data, Anavex Life Sciences will start a U.S. multicenter Phase 2 clinical trial of ANAVEX 2-73 for the treatment of Rett Syndrome with the support of Rettsyndrome.org.
The Michael J. Fox Foundation for Parkinson’s Research awarded Anavex Life Sciences a research grant to develop ANAVEX 2-73 for the treatment of Parkinson’s Disease. Ongoing preclinical research in this therapeutic area demonstrates that ANAVEX 2-73 ameliorates motor deficits in spontaneous rotational activity and forelimb use asymmetry, and exerts significant neurorestorative effects on the damaged nigrostriatal dopamine system.
The scientific rationale, preclinical data, and clinical development path of ANAVEX 2-73 as a novel treatment strategy for Rett Syndrome, Parkinson’s Disease, and Multiple Sclerosis will be discussed in more detail. This presentation will explore the links between preclinical findings and clinical trial development trajectory in our ongoing translational research efforts.
Are Anavex Pipeline Drugs Revolutionary?
No other set of therapeutic molecules has the potential to so radically transform 21st-century medicine.
First, all that I lay out below is informed conjecture, not a prophecy or prediction; merely some things to ponder (but DON’T buy any AVXL shares on the basis of these speculations).
There are reasons each or all of these could prove true. But this is not an invitation for criticism of each of these points. Merely some things to watch develop, should that actually happen at any future time.
1. Anavex 2-73 gets FDA approval to effectively treat Alzheimer’s. In practice, the new drug holds symptoms either at baseline (the level at the start), or in time and proper, adjusted doses, reverses cognition decline. It profoundly solves the social and economic problems of proliferating Alzheimer's Disease, globally.
2. Anavex 2-73 proves to be an extremely effective Alzheimer’s prophylactic, with physicians commonly prescribing the drug to middle-aged patients exhibiting the first behavioral or bio markers for Alzheimer’s, thereby preventing the onset of the disease.
3. Similar applications and results apply to Parkinson’s Disease, Amytrophic Lateral Scerlosis, Multiple Sclerosis, and a few other neurological diseases, all of which have a root cause of mitochondrial dysfunction.
4. Rett Syndrome severity is markedly suppressed, with treated little girls with the genetic disorder allowed to live near-normal lives.
5. Several psychiatric diseases become treatable and prevented by Anavex molecules.
6. Likewise for a number of cancers.
7. An Anavex molecule proves to be a remarkably safe and effective soporific, solving a giant medical problem, with profound medical and financial implications in the workplace, etc. Sleep deficits no longer harm daily living or workplace performance.
Imaginary? Check the drugs in the Anavex pipeline:
http://www.anavex.com/pipeline/
If Anavex gains approval for any one of these debilities, the company is a profound success. Anavex is an entirely new, different, and very promising consideration, with an utterly new, unique mechanism of action within cells and tissues. Anavex molecules do things inside cells no other drug can. Anavex molecules have the potential to safely restore cell functions (“homeostasis”).
Those who base their perspectives on straight chance, stochastics, and probabilities would properly claim the chances for success of more than even one of these outcomes is minimal and distant. But the success of a pharmaceutical preparation is not determined by chance; it is by actual chemical function within cells, organs, and organ systems. Check it out. The Anavex molecules really are new and different from any drug today. The prospect of their changing medicine in the 21st-century more than antibiotics did in the last is not, by any means, remote.
Not A Competitor
I may be wrong on this (experts please advise), but from my reading of this report, the new, proposed Alzheimer’s drug will suppress cytotoxicity induced by beta-amyloid wastes. The molecule binds to a protein, FLN (filamin A), essential to beta-amyloid toxicity. It is also projected that the accumulations of this waste protein will be reduced or absent.
Additionally, it is proposed that the new drug also inhibits new deposits of both beta-amyloid and tau tangles, the two protein waste products universally understood to be the direct cause of all the consequent Alzheimer’s symptoms.
Lastly, PTI-125, the new drug, is claimed to be highly anti-inflammatory. Inflammation is a major factor in a host of neurological (and other) diseases.
Is PTI-125 promising? Looks to be, at least conceptually. I’ve not read (haven’t searched for) any of the background murine lab studies, so I can’t comment in any detail regarding molecular or physiologic mechanisms of actions, other than above, the binding to the FLN protein.
The drug is just going into an early, first-with-humans clinical trial, to test both safety and dosage tolerance, not efficacy. No human data are posted or, to me, known.
As with Anavex 2-73, I can surmise PTI-125 might have its greatest use as an Alzheimer’s prophylactic, a prevention.
But, here’s the difference between the two new drugs, as I see it. PTI-125 may effectively reduce or adequately inhibit the toxicities emanating from waste protein accumulations in neurons and in nerve tissues. And, it may also cause removal of those wastes. All well and good. So far, nothing (except Anavex 2-73, putatively) does that.
Anavex 2-73 gets at its job much earlier in the disease process, at the very start of it, when reaction-controlling enzymes (properly folded proteins) are no longer produced, a result of mitchondrial/endoplasmic reticular disconnection and chemical transfer difficulties (ATP, Ca++, perhaps others). That’s a distinct advantage: attack and conquer the problem at its start (early disease stage), not at the end, targeting solely the accumulated waste proteins.
With Anavex 2-73's restoration of proper, normal mitochondrial/ER connections, the effective and normal synthesis of health-maintaining enzymes is restored. Waste proteins are once again effectively removed before they accumulate and poison things in the neuron and nerves. Anavex 2-73 attacks the problem at the start of the disease process.
Could PTI-125 be a competitor to Anavex 2-73? If so, it will first have to demonstrate safety and tolerability. Then, in a large human trial, it will have to demonstrate efficacy.
But should all of that occur, I don’t see this as a suppressing Anavex competitor. Anavex 2-73 has a multitude of benefits beyond mitochondrial function. It crosses the blood/brain barrier with ease (unknown, yet, if this happens with PTI-125 — it may have to be injected). The combination of oral administration and penetration into nerves and nerve cells is a distinct advantage for Anavex 2-73. The soporific traits are profound, and highly desired in an Alzheimer’s treatment.
And, the safety profile, lack of disqualifying adverse events (side effects) is just superb for Anavex 2-73.
I’ve seen nothing that would cause me to sell a few of my AVXL shares to buy a few Pain Therapeutics shares. The Anavex story is stronger, better, and in a much later chapter.
Under-the-Bridge Critics
The diversity and multitude of perspectives posted here on Anavex Life Sciences Corp are helpful. This is a good place (but not the only one, for sure) to conduct due diligence on Anavex and its underlying science.
I read most of the postings here, good or bad, well written or lose, opinion or fact. (Don’t much try to figure out the technical analysis postings; for me, just some oriented colored spaghetti with rather random lines and circles and obtuse numbers.)
But to more quickly surmise a poster’s perspectives, I’m creating a list of under-the-bridge “critics,” to allow me to skip certain postings. And, no, I won’t post this list. It’s just a sticky on my computer.
For what’s worth (very little) I added a few more today.
By Chance, Arrangement, or Cause?
Yes, it has been alleged that the multitude (high percentage) of Alzheimer’s patients in the Australian Phase1/Phase 2 clinical trial with remarkably maintained or restored cognition was merely a result of happenstance; that, somehow, only “high-responders” got picked to participate. They all had propitious genetics or neurological physiologies that responded so favorably to Anavex 2-73 for a continuing duration.
It has also been alleged that most or all of the favorable responses were placebo effects, inasmuch as this was not a blinded study. Each participant, along with doctors, nurses, care givers, and family members, knew that the promising new Alzheimer’s drug Anavex 2-73 was being taken by all. Therefore, there was widespread expectation of good results, the classic placebo effect.
As I can determine there can be only five explanations for the virtually universal occurrences of the posted favorable symptom outcomes:
1. Per chance, selected trial participants actually were all uniquely and universally super responders to Anavex 2-73; not at all representative of larger, more diverse drug-responsive Alzheimer’s populations.
2. The medical professionals, for untoward reasons, deliberately selected trial participants they somehow understood would yield favorable results.
3. The lack of trial blinding (everybody knew they were taking the real drug) and lack of a control arm (taking a sham pill) transparently allowed the placebo effect to so grossly taint reported outcomes.
4. Professionals conducting the trial surreptitiously selected, created, or reported only data they thought useful and favorable. The actual results were not in any way nearly as good as presented or perceived.
5. Anavex 2-73, in mid to mild Alzheimer’s patients, yields remarkable, unprecedented treatment outcomes of great favorability.
Let the reader decide on the matter.
Please, Just What Are the Others?
Indeed, I do not know of any other sigma-1 receptor agonists currently authorized or used for Alzheimer's treatment. We'd all like to learn of these. What are they?
And, what are the other FDA-approved sigma-1 receptor drugs for what other diseases? Important information for all of us to know and consider.
If they do exist, no one, to my knowledge, has ever presented them as Anavex competitors.
Enlightenment, please.
Therefore, the Imputation of Anavex Fraud Remains.
Enough on the matter. Let the readers, themselves, as they will, discern the issues.
But Why Only One Ihub Poster to Object?
But Where's the Normal Decline Plot?
Cute.
Can you tell us just why you failed to include, at an accurate scale and proportion, a plot line of normal Alzheimer's cognition decline?
Just how does that compare to your unique Anavex 2-73 plot? Better, worse, or the same?
And, for accuracy, plot out cognition in those without Alzheimer's.
Selective data presentation raises concerns, does it not?
Please, show us all three.
Forget it.
Tried to post an image of the famous graph, that so clearly shows cognition maintenance and improvement.
The matter must remain in the perception of each reader.
(And I won't be posting any "I told you so's" when the big Phase 3 data come out next year.)
(Having difficulty posting the graph.)
The Cognition Plot
Clearly, your interpretation of the plot of cognition assessments in the Australian trial are different from mine. The line goes horizontal (cognition maintenance), then begins to ascend (cognition improvement).
I have no reason to believe the data upon which this graphic was plotted were false.
Azeliragon Merely Slows Alzheimer’s Decline, Anavex Stops It
I just read the announcement of the Phase 2b clinical trial of Azeliragon, a new Alzheimer’s drug, with a unique mechanism of action. It’s not a sigma-1 receptor agonist (only Anavex has those), nor an acetylcholinesterase inhibitor, nor an immunological waste protein clearance drug. It blocks the receptor RAGE (Receptor for Advanced Glycation Endproducts) in the brain, thereby slowing cognitive decline.
But, apparently that’s all that really happens, symptomatically. Like the acetylcholinesterase inhibitors, the new drug merely slows cognitive decline; perhaps better than existing drugs; but it will be no competition for Anavex 2-73, which either maintains cognition or actually improves it.
There were also compounding side effects with the drug, at higher doses. Anavex 2-73 has none of those (merely very mild Level 1 and 2 side effects).
https://alzheimersnewstoday.com/2016/07/29/vtv-therapeutics-azeliragon-slowed-cognitive-decline-in-mild-alzheimers-disease/
Will Anavex Fix Cancer?
I Have No Farm, Not on the Line
Anavex Will Win, No Matter
All of what I described, telling the various reasons there is no Anavex enthusiasm in the investment community, is so. Good explanations, I think, of just why so few know of or believe the Anavex story.
But, that being the case, it in no way refutes the valid science of the Anavex molecules. That is not determined or validated by investment advisors. That stuff takes committed PhDs and MDs doing years of preliminary lab work, determining and validating just exactly how the Anavex sigma-1- receptor agonists work inside neurons and other cells.
The lab work, the hard biology studies, have been done, mostly on lab rats and mice. Those untrained in biology ignorantly claim that rats and mice aren't men, that the findings in those species can't in any way be extrapolated to real human beings. Therefore, the existing large body of Anavex sigma-1-receptor agonist studies (the majority of which I've closely read, with an adequate degree of understanding) can't be reliable predictors of successes in diseased humans. Trained biologists know better.
All that I've claimed about Anavex science is true. My projections of this into human diseases are, I think, extremely likely---so much so that I'm retaining my small AVXL position.
When new facts or perspectives emerge, I'll continue to post my thoughts on the topics. Since I began studying and following all of the Anavex science several years ago, I've discovered not a scintilla of contravening evidence. Quite to the contrary, evidence continues to accumulate validating Anavex drug safety and efficacy.
Until profoundly contravening data appear, I'm long and strong with AVXL. Unlike some others, I'm not in this to make a buck or two in the next month or two with some propitious day-trades. Near-term AVXL price fluctuations are for me tangential curiosities, of which nothing will be remembered once the new trials data emerge late this or early next year.
Again, the Anavex science is about as solid as can be. Human trials, in time, will silence the skeptics. I can wait (and be well-rewarded).
Ok, Just Why No External Enthusiasm