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Role of Early Application Unknown; But Potentially Big
That is, presently, a big unknown. Will earlier, pre-symptomatic administration of Anavex 2-73 yield enhanced therapeutic (or prophylactic) outcomes?
Personally, I expect such a finding; that those taking the Anavex drug at earlier ages, before any gross or frank disease symptoms present, will have greatly enhanced benefits. There are several reasons this could occur, including the following.
Again, the Anavex sigma-1 receptor agonists work, restore normalized neuron function, by re-connecting disjointed neuron organelles, mitochondria with their associated endoplasmic reticula. When those two cellular structures are in proper alignment, operating mutually, the neuron functions normally.
But when things fall apart, become disconnected, reaction-controlling enzymes cannot be properly made. A disease condition arises. Things operate badly within the neuron.
A parallel could be drawn with a car engine. Off the assembly line, all of the many parts of the engine are working well. But what happens if, say, the oil pump forcing pressurized oil into bearings and surfaces begins to fail. The engine, of course, then fails. When would you want a malfunctioning oil pump fixed, “treated?” Before it actually fails, or after declining oil pressure symptoms appear?
Repair after the engine has been damaged by poor lubrication will be expensive, if even possible. Fixing the oil pump before it fails saves the engine.
Will the same scenario be discovered in the now-started clinical trial in Australia? Will it be discovered that of the 300 taking Anavex 2-73 against their well-diagnosed Alzheimer’s, better outcomes will occur in those with less-developed symptoms, those treated at ever earlier stages of the disease?
Makes complete sense. Much less to “fix” at early disease stages, before irreparable damage has been done.
Then, finally, will it be discovered that preliminary administration of Anavex 2-73, even before any symptoms appear, simply prevents the occurrence of Alzheimer’s and/or other central nervous system diseases?
If I had genomic indications of any genetic vulnerabilities to Alzheimer’s, I know when I’d want to be popping an Anavex pill each day — as soon as I learned of this untoward genomic analysis.
When Anavex 2-73 gains approval for use (in any country, perhaps or probably first in Australia), what factors will prescribing physicians consider in deciding when to first dose patients with the drug? “Mrs. Dorgelmeyer, it does appear that your husband is having a few memory problems. But we don’t want to get him on this new Alzheimer’s drug too early. We can’t be sure that would be good. Have him check back in a year.”
That’s when medical practice tort lawyers and medical practice insurance parties will enter the scene, of course.
If efficacy of any sort is discovered in the trial (it will be), it’s going to be interesting to see how, and how long all of this plays out; both for patients themselves, and for those (of us) with financial stakes in Anavex Life Sciences Corp.
After Conception, Genes Don’t Much Change
Organisms get their genes, their specific sequences of nucleotides (A’s,T’s; G’s,C’s) at conception, from both parents. Except in rare situations, those genetic sequences, composing the individual’s genome, stay unchanged throughout life. Some varying expression of those genes can occur (epigentics), but each of us are stuck with the genes we got from our parents.
Of course, gene expression can be affected by aging processes. Many elderly people have genes that allow hair to turn white with age. So, perhaps expression of the referenced genes may have age components; may be expressed to greater degrees with age.
Nonetheless, genomic analysis will detect the genes, at any age. They are there, in the chromosomes or mitochondrial genomes, from conception.
Maybe Not.
Well, I presumed that dosing would start upon "enrollment." But, perhaps not.
"Dosing," the recorded taking of a pill each day, is not a complicated medical procedure. It would seem reasonable that dosing would start at the start (immediately after formal "enrollment").
But, perhaps not. If not, when should anyone think the clinical trial has started? Is it when people are signed up; or when they start popping the little pills? (Does it really matter?)
Positive News: Time for Naysayings
Anavex announces that the first subject is enrolled and is being dosed with Anavex 2-73 (or placebo) down in Australia. After great delay, the long-anticipated clinical trial, finally, has started.
In the last few weeks, postings telling the faults and fallacies of Anavex against central nervous system diseases have been relatively infrequent. Experts who know the real story have felt no commendable compulsion to protect all of us ignorant retail investors in AVXL. With no news, with nothing happening, we weren’t too inclined to jeopardize our additional investment funds.
But now, we are at great risk. We see that things are moving forward just as the company promised. In our ignorance, we might perceive things to be moving positively; that our holdings of AVXL might well appreciate.
Fortunately, however, the real experts on neuron biology and biotech investing are here to protect us. Thankfully, a multitude of postings re-informing inquisitive readers of the faults of Anavex will be carefully laid out and soon appear. Without the helpful cautionings, so many are likely to lose big with Anavex.
I’m one of those. In a year, after the Australian trial fails (Aussie government declines to authorize Anavex sales), after the symptoms of the little girls with Rett syndrome continue unabated, and Anavex fails against Parkinson’s, too, I’ll lament my failure to properly consider all of the helpful, protective information that my particular knowledge and training in cellular biology propped up my so overly optimistic but wrong views of Anavex science.
Before I lose my stock investment shirt (it’s very tiny) on Anavex, let me prematurely thank all of those who so carefully warned me. I paid no attention, and will suffer. I’ll be reading those so-helpful postings now to re-appear, and will so stupidly disregard each.
Let the warnings begin. The Anavex story is now so ever more questionable.
Thank you for that information. But, the MOA?
Thank you for relating important details of the actual paper; which were not accurately conveyed in the article. I was negligent in not perusing the actual paper.
The crucial matter, however, is this, is it not? Will the mechanism of action of Anavex 2-73, the re-connection of mitochondria with their associated endoplasmic reticula, thereby restoring normalized intracellular energetics, functional protein folding, and Ca++ exchanges also occur in these newly-discovered cells?
Or, do they have unique, novel organelle architectures and chemistries different from other neurons, thereby not open to sigma-1 receptor agonist therapy? If these cells are unique in that regard, just what is their unique cytology? Would they even be “neurons?”
But, only for schizophrenia.
Yes, these newly-discovered human brain cells may be different from brain cells in mice. But read closely. The only CNS disease anticipated to be involved with them might be schizophrenia. Parkinson’s, Alzheimer’s, or Rett syndrome are not mentioned.
And that’s because these newly-discovered brain cells certainly have mitochondria normally connected to the endoplasmic reticula the mitochondria support. They also have (when in health) functioning endogenous sigma-1 receptor agonists that facilitate normalized enzyme production within these neurons. If in a disease state, where the mitochondria and endoplasmic reticula have become disconnected, there is no reason whatsoever that Anavex 2-73 wouldn’t, as in regular brain cells in both mice and humans, reconnect the organelles, restoring normalized homeostatic processes.
Not an issue whatsoever for Anavex 2-73
Understand; Australians Are Different
Yes, isn’t it interesting that Anavex 2-73 is being allowed to be used, at least for now for only a few, but for up to 300 more when the trial starts down there — when here in the US the FDA, putatively, “...has concerns.” How come?
Well, it’s clear as a cloudless day in arid Australia. Those backward people down there just don’t have the understanding, nor care about, the potentially, even for-sure bad things that will happen to dumb (well, demented) people taking Anavex 2-73. It’s totally different from anything on any pharmacist’s shelf. Works (if it does) in unknown and very questionable ways. Yes, a few have taken the drug for nigh onto three years, with no really bad side effects (well, a few headaches and upset stomachs). But the clear thing is this: the untested new drug targets nerves, of all things. There are no such drugs that don’t have severe, sometimes even lethal side effects. Drugs for hangnails are one thing (they need close regulation, too, of course). But new, unknown, neuro-active drugs are just too dangerous to play with.
And that’s just what the Australians, bless their sub-equatorial hearts, are doing with Anavex 2-73. Up here, our FDA people are smarter. They know more. Gratefully, they are protecting all of us. We can sleep better each night knowing FDA smart people are diligently doing their jobs (well, on the nights we do fall asleep — in the absence of Anavex 2-73, a demonstrated soporific).
We are protected. Aussies aren’t. Smart MDs and PhDs only work in the Northern Hemisphere. If Australians would just scrutinize the expertise on this stock investment board, from the resident experts who post cautionary warnings about Anavex fallibilities, they, too, could be protected from their government’s allowance of a clinical trial where 300 Australian citizens will be jeopardizing their health and well-being. Hard to understand, isn’t it.
And there’s a big bridge for sale, somewhere, too.
Psychiatric Applications To Be Determined
Trails Irrelevant to Chemistry
Sorry, cellular chemistry is not dependent on, not controlled by humans conducting clinical trials. Conduct of a trial will not affect in any way how any of the Anavex molecules operate in cells or organisms. Irrelevant connection.
Penicillin didn’t kill bacteria because Fleming tried to see if it did.
Life-long Anavex Dosing?
If Anavex 2-73 (or any of the other Anavex molecules) proves to be profoundly prophylactic (disease-preventing) — as I think will be the case — the best age to begin dosing will need to be determined. Age 50? Seems reasonable to prevent Alzheimer’s. Not many show symptoms before that age. But, yes, other central nervous system diseases can have earlier onsets.
Several questions will have to be answered. Big one is this. Just what diseases and conditions might Anavex sigma-1 receptor agonists prevent when administered early enough?
What if it turns out that a host of human diseases result from, or are allowed to happen because intrinsic, natural sigma-1 receptor agonists fail at various stages of development or aging?
Now, this is a universal, uncontested biological fact. Virtually all chemical reactions in organisms are controlled, mediated, and promoted by precisely-formed, folded enzyme proteins. Mis-fold or distort an enzyme, and biochemical processes are disrupted. Many neurotoxin poisons of snakes and other organisms work by distorting enzyme shapes. They can no longer control or promote normal chemical reactions; death or injury ensue. A number of genetic diseases are known to occur when essential enzymes are improperly, incompletely, or absently produced. Most often, that happens because of a genetic defect; the nucleotide sequence of the controlling gene is out of order.
So, what if it’s discovered that Anavex sigma-1 receptor agonists restore normalized enzyme production in a host of cell types, at a variety of developmental stages, even embryonic? Too lengthy for me to deliberate the matter here, but for me, examination of all of the known murine study data, and the hints on the matter revealed by the Anavex pipeline drugs and the diseases they may treat, I am lead to believe that the roles Anavex sigma-1 receptor agonists might play in preventing just a host of developmental diseases and conditions, even in the uterus, could be (to use a phrase) “an iceberg.”
The Inflammation Factor
Yes, the “waste proteins” of Alzheimer’s, the beta-amyloids and tau tangles, are decidedly inflammatory, as proven in murine studies. Inflammation of nerves and nerve tissues is always problematic. When inflammation is well-controlled and properly restrained, it initiates and modulates appropriate immunological attacks on extrinsic pathogens, bacteria in particular; in some cases viruses. Well and good.
But inflammation can call out too many immunological defense troops (empowered leucocytes) who then fail to discriminate between invading, infecting pathogens from normal body cells and tissues. Not only are pathogens “controlled,” normal cells and tissues are attacked and slain. One needn’t know much biology to imagine what results when nerves are so attacked.
The author states, “It seems that if given early enough ANAVEX 2-73 can stop or even reverse progress of the disease.”
If Anavex 2-73 can cause neurons to accurately create proteins, by allowing endoplasmic reticula to function normally, enzyme proteins will be folded into their proper, functioning shapes, thereby creating normalized, healthful chemistries within the neuron. No disease onset.
Personally, I’ve contended this myself a number of times. Administering Anavex 2-73 after beta amyloid and tau wastes have profusely accumulated and induced neuron-destroying inflammation may not be useful. The wastes have accumulated, induced inflammation, and affected neurons cannot be salvaged. But start the treatment early, before waste proteins have much accumulated, and the normalized protein enzymes from the Anavex-restored endoplasmic reticula will maintain, even restore neuron function.
Why wait to treat Alzheimer’s with Anavex 2-73 until severe, irreversible damage to neurons and nerves has occurred? Treat at the very first signs of Alzheimer’s, before irrevocable damage has occurred, before waste proteins have accumulated to any degree.
With 300 people taking Anavex 2-73 in the upcoming trial, a computer’s plotting of outcomes should reveal if this scenario is accurate. If it is, those taking the drug at earlier stages of the disease will have better results. Those at more advanced stages will have reduced positive outcomes.
I’ve also contended that eventually Anavex 2-73 may be universally prescribed to virtually every one, at some yet to be determined age, say, age 50. With that, any of the central nervous system diseases (or others) can be prevented from developing. Treated and prevented at the start, before any irrevocable, chronic damage has been done.
When you were ten, your mother in winter used to say, “Better put on your coat. We don’t want you to catch a cold.” Will physicians sometime be saying to their mid-aged patients, “Well, I see you are approaching your 50th birthday. Time for you to start taking an Anavex pill each day. We don’t want you to develop any of those horrible diseases people used to get?”
Only If...
Placebo Effect Will Explain Everything
Let’s see if this scenario takes place.
The Australian trial of Anavex 2-73 begins. As per appropriate clinical trial protocols, the trial is double-blind. No one but some lines of computer code knows who’s getting what: low-dose, high-dose (experimental arms of the trial), or starch pills (placebo arm). Everyone is taking a daily little blue pill.
And, for three months, not a word from anyone on either efficacy or tolerability (adverse effects).
But, then, in about the fourth month, a few reports of profound efficacy leak out, from patient acquaintances or other external parties. “I know Sam. He’s not the same man now. Something’s really happening with him.” Statements like that.
Those sorts of leaks continue to appear in ever larger numbers (but, “...still just a handful.”)
Finally, a few news reports from Melbourne appear. “Family members of patients participating in a new Alzheimer’s drug trial have reported very interesting changes....”
From the scant information available, a number of parties (external to the trial, not the hospital, physicians, or Anavex) begin to state that, “...this drug is really going to work.” The share price of AVXL begins to climb.
That’s when we will hear from all the “experts,” both medical and investment, saying, “The reports of Anavex 2-73 successes against Alzheimer’s should not be relied upon. A classic ‘placebo effect,’ where patients and their families so much want a drug to work that they see and feel that it does, even though it really has no specific physiological mechanism. Dozens of drugs to treat Alzheimer’s have been tried; not a one has worked. There is no indication Anavex 2-73 will be any different, regardless of the strong hopes of patients and their families.”
If Anavex 2-73 does yield significant improvements in patient Alzheimer’s symptoms, when will the last Anavex critic be stilled? The most adamant, of course, will assertively claim right up to regulatory approval of the drug that “...it was all a placebo effect.” These people simply know, now, and then, that there simply cannot be an effective treatment for Alzheimer’s. End of story — for them, at least. But not for those of us who have held AVXL positions for many years, nor for the millions Anavex 2-73 will go on to successfully treat.
“It’s all just a placebo effect!” For how long will that be the “explanation?”
Anavex Silence is Golden (And Well-advised)
All of us would like frequent, detailed updates on things happening inside Anavex Life Science Corp. Wouldn’t it be wonderful if, say, every Monday morning Dr. Missling would send out an email, answering the many questions we would have submitted to him over the weekend. With that, we’d be really informed, be able then to intelligently invest or divest from the company. No mysteries about anything. Just the sort of thing CEOs ought to be doing, right?
Now take one of the most preeminent CEOs, a man who created a new car company and engineers and sends rockets into deep space. What did he just do? Tweeted some really helpful, informative “inside” information on his company, telling a big move he is anticipating. Good for investors to know, right?
Well, how’s that freely-offered inside info turning out? The Securities Exchange Commission is investigating; dozens of lawyers are cogitating about how to “represent common shareholders” in suing for lost investment funds, etc. In just a few days, with nothing more than that tweet, the shareholders’ value has declined about 9%. Lawyers are salivating.
In WWII, it was “loose lips sinks ships.” Today, loose, freely dispensed corporate information, particularly in young, start-ups with unique, proprietary, yet-unproven technologies and products, sinks corporate futures. Intelligent corporate execs learn early (as has Dr. Missling) that no matter how full the hand a company owns, the cards must be kept close the chest. Dozens of lawyers are ready to pounce at the first apparent information discrepancy. “Members of the jury, my many clients have been severely harmed by the clearly inappropriate and inaccurate information Anavex Life Sciences Corp has dangled to the unwary public. For example....” You can imagine the rest.
When appropriate and propitious, all of the cogent Anavex information will be announced and become known; with very favorable outcomes for virtually every party (except market makers, day-traders, and shorts). 'Til then, intelligent Anavex shareholders must be patient. Likely it will take longer than any would wish — but the results will be rewarding altogether.
Dr. Missling, don’t jeopardize the corporate future of Anavex. Keep all the “iceberg” information to yourself. My thanks! This Titanic will both sail and dock, untouched by a mid-night iceberg. Our crossing won’t be the fasted. But its payoff will be the biggest.
Strong Relationship — Share Price To Naysayings
The number of postings telling how Anavex is a bad investment, because the science and management of Anavex Life Sciences Corp is deficient, are presently infrequent.
What happened? Where, now, are the postings telling the details of Anavex deficiencies? The science is un-affirmed. Management is deficient. Promised clinical trials are wholly tardy. Etc.
Concomitantly, the AVXL share price has languished.
As the share price ascends, so does the frequency of postings telling, in detail, why AVXL is a bad investment choice. When the price descends and stays low (as now), so few are laying out the reasons AVXL is a bad investment idea. A strong relationship.
What is it about an ascending share price that prompts the postings? What is it about a languishing share price that keeps certain information so quiet?
Does The “Iceberg” Harbor Lots Of Human Diseases?
I’m betting that Anavex lab people have run a host of tests checking what their molecules do to aging rats and mice. And for very appropriate reasons they aren’t letting a sliver of what they’ve found become known beyond the locked lab doors.
At the simplest, most elemental, if Anavex 2-73 provides even just symptomatic stabilization of either Parkinson’s or Alzheimer’s it will be a pharmaceutical revolution. Very high chance, however, that at least for some, symptomatic remission will occur. Even more revolutionary.
But what if it turns out that organelle disconnections are the root, basal cause of most or all pathologies related to aging? And, what if any of the proprietary Anavex sigma-1 receptor agonists (not just Anavex 2-73) are able to either prevent organelle disconnections or restore youthful intracellular architectures? In the first case, debilities of aging could be prevented. In the latter, youthful stages of health could be restored.
I’m particularly interested in learning human applications of Anavex 3-71. Murine data with the molecule indicate that at least for some conditions it has higher levels of treatment efficacy than Anavex 2-73.
And Anavex Life Sciences Corp owns other unique sigma-1 receptor agonist molecules, awaiting eventual testing on diseased humans.
In the Anavex iceberg are there molecules that will slow normal aging processes, allowing humans to live healthfully well into their later decades? I’m betting (have bought a few hundred AVXLs) that Anavex researchers now know the answers to these “fountain (drug) of youth” questions. If positive, it’s not really an iceberg. It’s a continental glacier, which will flatten medical treatment landscapes.
Why Not In Children?
It is noted that with the incidental exception of cocaine addiction, none of the referenced conditions, amyotrophic lateral sclerosis, Alzheimer’s disease, Huntington’s disease, general neuropathic pain, or Parkinson’s disease, much occur in children. They almost always appear after childhood. How, then, might childhood prevent the onset of these severe conditions until later in life? Might that have any implications for Anavex?
For mitochondrial dysfunction diseases successfully treated in murines by Anavex sigma-1 receptor agonists, the generalized mechanism of action is known: re-connection of intracellular mitochondria with their associated endoplasmic reticula, thereby allowing normalized biochemical processes.
For mitochondrial dysfunction diseases, typically with adult onset, is it not reasonable to assume that before disease onset, cells functioned normally; before organelle disconnections occurred? Those happen as a process of aging. Older is “worser.” Intracellular organelles wear out with age. Some actually disconnect and can no longer function mutually. Mitochondrial disease results.
What, then, are the broader implications of any of the Anavex sigma-1 receptor agonists being able to stop any of the various intracellular aging processes, being able to both re-connect and maintain organelles? There is now abundant evidence in murines (rats and mice) that the Anavex molecules can do this for a number of diseases and conditions. Upcoming human trials will affirm positive treatment outcomes for three human conditions.
Might there be more to follow? Might Anavex molecules be able to maintain (stop aging) or restore dysfunctioning organelles (restore normalized health) in a much wider number of human conditions? Perhaps most or all of the ones associated with aging?
Well, Accept It – Anavex Not (Yet) Newsworthy
Those who have been following the Anavex story; who have investigated and understand its unique and revolutionizing science, anticipate how it will turn out. Eventual authorization to sell Anavex 2-73, which will then provide unprecedented prophylaxis and/or restorative or stabilizing treatment for millions with Alzheimer’s and other central nervous system diseases. Hard to understand just why all of this is so neglected by news writers and reporters. It’s as though Anavex Life Sciences Corp didn’t exist.
Well, in the minds of conventional media people, it doesn’t. Think not? Write a few well-constructed emails to any news entity you’d find appropriate, telling how and why the Anavex story should be reported.
Well, don’t waste your time. (I write with professional competence, but will refrain.) Science and medical news writers continually are confronted with new, revolutionary drugs and treatment protocols for a host of diseases and conditions — none of which have FDA approval for use yet. For them, Anavex can only be just another over the horizon, too good to be true disease treatment option. Publication of just one such story, before there are any useful human outcomes or records (30 folks in Australia certainly don’t count), after which the drug then fails, is the sinking of a writer’s career. Nothing to gain; everything to lose.
The majority of medical “experts,” PhD’s and MD’s, themselves utterly dismiss and neglect the Anavex stuff. Until a bunch of those people start telling science and medical writers that the Anavex story is going to lead to some remarkable outcomes, Anavex will remain a hidden, suppressed story, unworthy of being written about or presented to interested lay readers.
I’ve stated before: Until favorable clinical trial results begin to leak in copious numbers, Anavex will stay hidden from the public.
But, then....
Wrong Message; Will Continue To Post...
...I'll continue to post here. A super group of people, with great interest in a remarkable company with game-changing (good or bad; I think GOOD) molecules.
But my postings will tend to be in the manner of the last one; deliberations on larger issues and outcomes. When appropriate (infrequent), I'll involve my science-teaching skills to clarify or elucidate otherwise convoluted biological concepts related to the Anavex molecules. My general intent is to make clear to general Anavex investors the probity and viability of the Anavex effort to revolutionize 21st-century medicine. The trials themselves, however, will be best at that.
I'm in the cheap seats --- but watching closely. Have a practiced eye following and understanding (and teaching about) biological processes.
A Sign Of Bad Teaching
Thank you. Yes, so many technical terms are mispronounced. It happens because science teachers, either in high school or college (mostly high school), have not properly instructed students on the matter.
I’m a retired high school biology teacher, and you can bet that none of my kids went off to college and embarrassed themselves with amateurish enunciations of any of those long biological terms. They knew how to pronounce “nicotinamide adenine dinucleotide phosphate.” We’d practice saying it, just as kids in German class practiced saying “Alzheimer Krankheit.”
If you can’t say it, how can you know it?
Disintegration Of Biogen Alzheimer’s Treatment Won’t Elevate Anavex
It would be nice to think that with the ever more prominent understanding that a focus on amyloid and tau wastes is fruitless, attention must then pass to the last new treatment approach left standing, Anavex.
But, sorry, that won’t happen any time soon. Anavex isn’t seen standing; isn’t seen at all. Simply not in the minds of either medical or investment writers. Until positive human clinical results are reported, Anavex Life Sciences Corp will never be written about, never reported about. As I’ve mentioned previously, medical people have had their entire careers (last 30 years) parked on the amyloid waste protein thesis. Investment writers get their information from the legacy medical people. Until a bunch of those older guys, watching their careers beginning to fade, spontaneously start telling investment writers about Anavex, Anavex will remain an unknown entity of no perceived promise.
Nothing good will be written about Anavex until a pile of replicated, positive clinical results appear. There were a handful of those in the Australian Phase 1 trial, yielding no recognition of Anavex whatsoever. Gonna take dozens of people responding positively in any of the three upcoming clinical trials before anything accurate and positive will be written about Anavex. ‘Til then? We wait....
Rhett Was A Guy In A Movie
No "h" in Rett Syndrome.
Properly, It Is “Altzheimer’s” In Pronunciation
The disease is named for it’s descriptor, Dr. Alois Alzheimer, a German physician.
In German, the letter “z” is not pronounced “zuh;” rather, properly, it’s “tz.”
Phonetically, it’s properly pronounced “ALTZ-high-mers.”
https://dictionary.cambridge.org/us/pronunciation/english/alzheimer-s-disease
In Five Years, Let’s See
Yes, But Not Published.
Degenerative Eye Diseases Associated With Alzheimer’s
Anavex’s Obscurity Is Not a Puzzle, Considering....
Anavex Evidence Is Copious — But Unconsidered
Well, it’s not as though one grad student 10 years ago fed a bit of Anavex 2-73 to a cage full of rats with some generalized central nervous system problem, and they all got better — providing the only known hint of useful efficacy.
Instead, there are a host of well-controlled, extensive, precise murine studies of Anavex drugs against a number of diseases. They all point to treatment efficacies.
Of course, legacy (dare I say, last-century) Alzheimer’s stakeholders continue to be locked into a focus solely on waste proteins, beta-amyloid plagues and tangles of tau proteins, as the only things to which new treatments should be directed. Clear those proteins; no Alzheimer’s.
And, that’s true. But the multitude of immunological trials Big Pharmaceuticals have spent billions of dollars on have all been profound failures. Now we see reports that a number of Big Pharmas have turned away from Alzheimer’s research.
Nonetheless, the Anavex data have been published. The Anavex sigma-1 receptor agonist molecules offer the best hope to solve the Alzheimer’s problem. They are safe, and they work.
But the Anavex evidence, whether now in murines, or soon, in humans, is going to be resisted. It negates the vaunted pronouncements of the real Alzheimer’s experts. Professional research careers are threatened. Entire floors of medical research labs will become vacant if Anavex assumes the central position and focus of Alzheimer’s research.
Frankly, one needn’t be able to describe or properly pronounce the names of the many molecules in any of the several chemical pathways in properly-functioning neurons to examine the evidence about which Alzheimer’s treatment approach is heading in the right direction. Billions of dollars of Big Pharma monies continue to prove that approach will not yield effective, safe Alzheimer’s treatments.
All of the existing data for Anavex, however, is positive and supportive. Ideally and intelligently, the Alzheimer’s stakeholders community would be pushing hard for clinical studies to get Anavex 2-73 to market. But intelligence is not the controlling factor. It’s self-gratifying protection of professional careers.
Two professions are noted, through centuries, to be exceptionally resistant to change. Farming and medicine. Both place full stock on what has been practiced previously and presently. Anything new that confronts accepted knowledge and experience is vehemently resisted.
We see that, of course, with Anavex and its unique science.
Why I’m Holding My Moderate AVXL Position
Irrespective of the many postings telling why Anavex 2-73 is not likely to provide sufficiently favorable clinical results to allow or prompt FDA approval of the drug for commercial use, on the basis of the information below I’m holding my moderate AVXL position until complete regulatory resolution; until the drug gains approval for sale and use in any particular country.
In several years (I’m looking over the horizon, to 2023) my investment in Anavex Life Sciences Corp will have proven exceptionally rewarding; or the company will have gone bust and I will have lost my investment dollars. For the reasons below (and others), I think I will win.
1. I am a biologist, know and understand the functions and chemical reactions in neuron organelles; understand the ample body of evidence showing that Anavex 2-73 reconnects disconnected mitochondria with their associated endoplasmic reticula. This rejuvenates neuron functions. With this, the endoplasmic reticula can fold proteins into their proper shapes, allowing normal neuron chemistries to occur, obviating the many pathologies caused by mitochondrial dysfunctions (including most forms of Alzheimer’s, Parkinson’s, and a number of other central nervous system conditions).
2. There is an ample number of murine (rat and mice) studies showing significant therapeutic outcomes against various mitochondrial dysfunction diseases. Mice, neurologically are (to a degree) “men.” Conversely, I’ve discovered no murine studies showing that Anavex 2-73 fails to restore mitochondrial functions in transgenic murines (with transferred pathological disease genes, particularly Alzheimer’s).
3. Wonderfully, Anavex 2-73 is ably absorbed in the gut and crosses the blood/brain barrier, and, finally, diffuses into or is absorbed into the intracellular space of neurons. As in the murine studies, this means that in humans it can be administered orally, not by intravenous or intramuscular injection.
4. The small human Australian trail was conducted to assess only safety and tolerability; not any generalized Alzheimer’s treatment efficacy. Safety in humans was clearly established, with no severe or disqualifying side effects (merely a few head aches, etc.). Adverse events are a major concern and common, almost universal occurrence with psychoactive drugs. Anavex 2-73 had none of any significance. Tolerability, dosage effects, were determined, yielding no results to prevent anticipated dosages in consequent human trials. Safe and tolerable.
5. Although not designed as a test for desired efficacies, the Phase I Australian trial had a number of participants gain astounding reversals of their Alzheimer’s symptoms; approaching or attaining normal cognition. Yes, the trial cohort (number of participants) was too small to extrapolate these very positive outcomes to a larger, statistically-valid population. Nonetheless, attributing those disease turn-arounds to mere chance dismisses or discounts what is known to happen in virtually all Alzheimer’s cases. It is universally a lethally progressing disorder. Symptomatic turn-arounds such as those in the Australian trial are virtually unknown. They were plausible because they happen in transgenic murines with Alzheimer’s symptoms and genes, treated with Anavex 2-73.
6. Curiously, the majority of the Australians in the small safety and tolerability trial elected to, and were given permission to continue taking Anavex 2-73 after the formal, monitored study was completed. This has continued without interruption now for many months. Two supportive factors. Australian medical officials had to give their permission to allow the trial participants to continue to take the drug, even though the trial itself ended. The reasons Australian officials allowed this (never disclosed) can only support the notion that the drug is both safe and, at least to some degree, effective. Likewise, the patients, for whatever reasons, personally elected to continue to take the drug. That would not have been the case had they perceived it to cause problems, or be without some health benefit.
7. Anavex Life Sciences Corp has not just Anavex 2-73, but a number of other proprietary molecules with equivalent or exceptional neuron rejuvenation powers. Preclinical murine studies of Anavex 3-71 suggest that it is even more efficacious against a number of human conditions than Anavex 2-73. The Anavex drug pipeline is ample, with a number of promising molecules that may eventually treat or prevent a host of human diseases and conditions.
8. Not a single murine study has shown Anavex 2-73 to fail to provide some degree of symptomatic relief for appropriately targeted conditions. There is no body of evidence showing that the drug fails.
Investing in start-up biotechs with only a promising story, with no approved drugs or devices to sell is a risk. For Anavex Life Sciences Corp it’s a risk I’ve decided to take with my moderate holding of AVXL shares. To determine this success, I’ll will wait until at least 2023, allowing time for everything required to work out. For me, the existing evidence says that it will.
Yes, When Anavex By Utter Desperation?
Good point. When will it become generally recognized that nothing in the medical textbooks, nothing being envisioned by legacy Alzheimer’s treatment stakeholders, or anything proposed or tried by Big Pharmaceuticals has even the remotest chance of providing any usable Alzheimer’s treatment or prophylaxis?
When will it be generally agreed that, “Well, we’ve been working on the Alzheimer’s problems for three decades, and simply, nothing has worked; nothing will.”?
With that then-accepted position of desperation, Anavex science can rise to a new level of considered viability. “Every Alzheimer’s treatment has been a now-realized failure. But there is one new sliver of hope. Down in Australia....”
Complete the scenario as you see it developing.
"Wild type" means the normal, common gene; widespread, most common.
Hampel Can’t Know
Well, pretty impressive stuff about Anavex and its genomic parsing of Anavex favorable clinical test participants.
But clearly, Dr. Hampel just doesn’t know what he’s talking about. Readers closely following various postings of the real experts here on this message board now know that Anavex 2-73 is a) going to fail the upcoming clinical trial and b) the trial itself is flawed in a number of ways. Anavex Life Sciences Corp will meet an unfortunate but carefully predicted end. People who know more than Hampel have laid this all out for us here.
Who’ya gonna believe?
Anavex 3-71 Works in Transgenic Alzheimer’s Rats
We Are Protected By The No-risk Postings
I sleep better each night knowing that we have access to a diversity of opinions and information on Anavex Life Sciences Corp (AVXL) as a worthy, will-pay investment.
Giving me the greatest sleep are the postings from people who are here only to protect unwitting investors; people like myself overly entranced with the presumed magic of Anavex neurochemistry. Those postings must be accurate and useful, inasmuch as they are in no way tainted by any AVXL purchase. Just the opposite. No skin in the AVXL game – here just to “help out.” Protect the innocent, etc.
But I sleep well, utterly disregarding such advice. I’m content with my personal understandings of Anavex science and its potentials.
Let’s all check back in, say, 2023, and see how things have worked out for all of us, both those with AVXL positions and those who have had the particular intelligence to stay away from the company and its equities.
Will There Be Clinical Information Restraints?
Everyone looks for the earliest clinical results from any of the three upcoming studies of Anavex 2-73 in humans, whether in little girls with Rett syndrome, or older people with Parkinson’s or Alzheimer’s diseases. Will be hard to contest or dismiss those results, whether positive or negative. Clinical results will be the definitive thing for Anavex.
For Anavex investors, the most difficult situation will be if any sort of intermediate, on-going clinical results are never disclosed or leaked; that everyone must wait for the formal end of the studies and the subsequent appearances of their technical results.
I ask, then, will those conducting the three trials configure things so as to somehow keep intermediate results in-house and undisclosed before the trials formally end?
Will trial participants and their families and doctors have to sign non-disclosure agreements (NDAs), agreeing to keep their perspectives and thoughts silent until formal results are published? Might continuance in the trial be subject to such non-disclosure?
I’ve suggested previously that it might be difficult to keep a tending nurse or mother of a Rett syndrome girl in the study from inadvertently telling friends or family members about a Rett girl who, after taking the drug, has clear symptomatic improvements of any number of frank (visible) symptoms.
What if, say, 90 of the 300 Alzheimer’s patients taking the drug in the Australian trial simply regain their cognitive functions, sleep well, and clearly progress positively? How, or would those results remain hidden for the remaining weeks or months of the trial?
I’d love to learn how the medical (and legal?) people conducting the trials will attempt to restrain preliminary releases of individual clinical results — if they will or can.
AVXL Share Price No Mystery — Impatient for Increases
There is no mystery whatsoever about why the AVXL share price remains “low.”
More people have wanted to sell, even to take a loss; than to hold and wait for some future price gain.
Harsh reality is this. Many AVXL shareholders bought the equity on the presumption that the medical world would rather quickly learn about, agree with, promote, and use the company’s revolutionary science. Therefore an expanding market demand for shares.
Well, so far, none of that has happened. And no immediate prospects of that in coming months, or even a year or two. Therefore, sell; move on.
The quick-profits game has been a loser for those who have played it with AVXL shares. Sell, and move on.
Some, however, have purchased Anavex equities as an investment, long-term; realizing that getting a unique, revolutionary new drug on the market will take more time than anyone wishes. We’ve taken some discretionary funds and have set them off for profits sometime in the more distant future. Personally, my target date is in the general 2013 year time frame. Then, I’ll ponder my Anavex investment and decide if it was a good one. If poor, if Anavex has gone bust by then, I will have lost virtually every dollar used to buy AVXLs.
But, if as expected from the profound science of the Anavex molecules the company prospers, I will have benefitted very rewardingly. For me, with my 5-yr time frame, Anavex Life Sciences Corp is a binary investment move: I’ll win big, or lose it all.
So far, haven’t seen anything predicting or mandating a future loss. Just the opposite.
Go, Anavex. I can wait.
Why Doc Can’t Keep Up
It is perceived that trained, licensed physicians are among the smartest, most informed people on the planet. A dozen years of college-level training, under profound medical faculty, at first-rate med schools and hospitals. No one is smarter, more capable, than a Good Doctor.
Well and good.
But last year, how many PubMed medical research reports were published, many having very useful and applicable patient treatment findings and recommendations?
1,282,432.
http://dan.corlan.net/cgi-bin/medline-trend?Q=
That’s about 3500 new papers a day. If only one tenth were useful to any particular physician (he’d have little way of knowing which were), a physician hoping to keep up with new information would have to read 350 papers a day. At 1 percent, a “mere” 35 papers a day. That’s two or three hours of reading time every day, day in, day out.
For those unfamiliar, PubMed is the major medical information site posting virtually all of the published papers on every medical topic. https://www.ncbi.nlm.nih.gov/pubmed
So, how come so many (well, all) physicians simply lack complete information on the latest medical findings? Simple. It’s impossible for any human to access, read, and compile the overwhelming amount of medical information generated each day. No physician in the world, even yours, can possibly stay well informed and totally up to date. Just too much information to take in. Not humanly possible.
A Tough Story To Tell
It’s hard for news reporters to tell any of the Anavex story, for several reasons.
First, for reporters, the evidence supporting Anavex 2-73 as a profound new and successful treatment is simply weak or altogether lacking. A few Australians found some relief in merely a safety and tolerance trial. Reporters won’t report that because the number of participants was inconsequentially tiny. “Could’a been mere chance.”
And, it was in a foreign country. English-speaking yes, but not regarded as a hot-bed of medical advancement.
Then, the mechanism by which the drug putatively worked was “not what is known” about Alzheimer’s, that it’s primarily caused by beta-amyloid and tau protein accumulations. Every Alzheimer’s expert in the world, for two decades, has focused on those waste protein accumulations as the sole target for some effective treatment. Get rid of the waste proteins, problem solved.
And the people working so diligently (but unsuccessfully) on that are all in the labs of big pharmaceuticals. Very clear, the Alzheimer’s problem is so massive, so complicated, so expensive only a few big pharmaceuticals have the financial and intellectual resources to effectively, some day, conquer the disease.
No one has ever heard of “Anavex Life Sciences Corp.” Tiny biotech start-ups commonly proclaim incipient solutions and treatments for a host of diseases; but they never work out. The reporters just know that Anavex is such a company. They claim to have some molecule that magically fixes aged and degraded neurons. “Sure, tell us another one.”
Frankly, no science, medical, or financial writer is going to risk a career trying to boldly set forth the Anavex story just yet. So far, it’s only that; a pretty weak agglomeration of animal studies coupled with a yet-very-questionable mechanism of action — one that very few “experts” will ascribe to or authenticate.
However, this perspective of reporting reluctance will change on a dime when a few substantive reports emerge that some Rett syndrome girls have gained some degree of symptomatic relief, or, likewise, some of the 300 Australians getting the drug in the new trial are reported (surreptitiously) to be now sleeping soundly, with noted restoration of cognition.
With any number of such events, reporters will have to answer the question, “How so?” The central involvement of Anavex 2-73 can’t then be dismissed.
“Experts we talked to could not explain the results leaking in ever larger numbers from the Australians in the Anavex 2-73 clinical trial. Dr. Snorkelberry, a worldwide Alzheimer’s expert said, ‘I strongly question all of these new reports from the Australian new drug trial. It has another six months to run to completion. We must wait to see if any of this is real. Way too early to tell. I can’t see how that drug can work, actually.’”
That could the nature of the earliest news reports.
But eventually, the tabloid press starts printing stories entitled, “Miracle drug restores Alzheimer’s brains in Australia!”
The mainstream press then has to play catch-up. The world soon realizes that Anavex 2-73 really is working therapeutically in the Australian trial.
Everything will be different, then.
Not Precision Medicine, Per Se — Just Anavex!
The Play “Anavex 2-73" To Open In Australia
FDA recalcitrance regarding any sort of prompt approval of Anavex 2-73 may be caused by a number of factors — things that may not be so entrenched or controlling in, say, Australia.
By whatever mechanism or arrangement, let it occur so that those who choose to be treated by Anavex 2-73 for their Alzheimer’s dementias can be. If that happens in the US (no indications that it will), all well and good.
But there will be a much better chance that the first population to gain Alzheimer’s treatment (and prevention) access to the drug will be the Australians. The up-coming Phase 3 clinical trial will be centered down there. Local medical officials and physicians will see results first-hand, as they progress, even, per chance, in the early months of the trial.
With any sort of positive data early in the trial, the arithmetic of any 13-yr old will instantly reveal the profound national and institutional cost savings resulting from widespread use of the Anavex drug in a national population.
Here’s the central question. Where is Anvex 2-73 most likely to first gain governmental approval for generalized medical use? Is the US FDA set up for and promoting such an outcome? Or, perhaps, are things more propitiously arranged and aligned in Australia?
If it’s the latter (I think it is), it will be interesting to follow the involved social and economic factors that would then play out here in the US. “Hey, how come we are reading about how Australia has conquered the Alzheimer’s problem, but the FDA says [As they always do.] ‘Not enough data yet for Anavex approval in the US’?”
Gonna be really interesting to watch the eventual approval of Anavex 2-73 play out, no matter by what means, no matter where. If the drug provides even the most minute therapeutic benefit; say, holds Alzheimer’s patients at a start-of-treatment baseline (just keeps patients from getting worse), the diverse economic impacts will be in the billions of dollars. Moreover, if the drug performs as all of the cogent information predicts, that it not only stops the lethal progression of Alzheimer’s but either reverses or prevents the disease, the economic impacts are even greater, by an order of magnitude.
Who, per chance, could be against either of those outcomes? Let’s see. Large legacy institutions that “treat” and care for Alzheimer’s patients; nursing homes, hospitals, neurology clinics, others. Ponder whose life styles, incomes, and professional careers might be threatened by a successful, global termination of the “Alzheimer’s problem.”
Might any of those parties “express great concern about the inadequacies and safety hazards of this unproven new drug?”
On the other hand, who would welcome it’s availability? Foremost, of course, would be national governments and their taxpayers, who bear most of the diverse costs of those with senile dementias. Social, citizen groups would support widespread use. Private health insurance companies?
Let’s watch. The Anavex 2-73 story is not opening on an American stage. A new production is about to begin in Australia. A cast of 450. Get your tickets now. Australian medical cost officials have theirs; will be sitting right in front of the stage. News reporters and cameras in the seats just behind them. House lights soon to dim; let the curtain rise. To be one of the greatest stories in two millennia of medicine.