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Why no published, professional negations of Anavex?
As I've mentioned, it's reasonable for readers to question my postings that tell of the profound science, efficacy, safety, and applications of Anavex 2-73. I'm merely a biology teacher familiar with (and having taught) the elements of cellular organelles, enzyme control of cellular reactions, etc. I am not a neurochemist nor medical researcher. I have no PhD.
Because of this, a number of posters have claimed or implied that my evidence-based and evidence-presented support of Anavex cannot be accepted as reliable or useful; that there remain a multitude of unanswered questions regarding the validity of Anevex trials data (both murine [animal] and human).
Missing from this discussion, however, are the postings of any reliable, professional that is contrary evidence supporting the Anavex as a no-go perspective.
If my support of Anavex is unfounded, just why haven't people with "real" expertise posted plausible, documented evidence negating my positions?
Well, maybe few or none of those people waste time on some otherwise obscure Ihub board. Understood.
Nonetheless, the critics and skeptics of Anavex should be posting papers and presentations by professionals that take apart the company's (and my) explanations of how Anavex restores neuron homeostasis. So far, amidst this on-going discussion, not a single posting has presented a single page of negating data from any real experts. I've presented the data and explanations offered by the Anavex scientists. Why is it so difficult to find and post contravening evidence?
Because there is none. Anavex 2-73 works and performs exactly as the company claims. By their silence, real professional agree.
Alzheimer’s disease (AD) is characterized by deposition of amyloid-ß (Aß) plaques and neurofibrillary tangles in the brain, accompanied by synaptic dysfunction and neurodegeneration. Antibody-based immunotherapy against Aß to trigger its clearance or mitigate its neurotoxicity has so far been unsuccessful. Here we report the generation of aducanumab, a human monoclonal antibody that selectively targets aggregated Aß. In a transgenic mouse model of AD, aducanumab is shown to enter the brain, bind parenchymal Aß, and reduce soluble and insoluble Aß in a dose-dependent manner.
In patients with prodromal or mild AD, one year of monthly intravenous infusions of aducanumab reduces brain Aß in a dose- and time-dependent manner. This is accompanied by a slowing of clinical decline measured by Clinical Dementia Rating—Sum of Boxes and Mini Mental State Examination scores. The main safety and tolerability findings are amyloid-related imaging abnormalities. These results justify further development of aducanumab for the treatment of AD. Should the slowing of clinical decline be confirmed in ongoing phase 3 clinical trials, it would provide compelling support for the amyloid hypothesis.
Please advise. MOA?
Readers will note I seldom use acronyms. I write out the entire word or phrase, so there is no confusion.
In my circles, I've not encountered "MOA." Which of the 47 listed meanings of this shown here is intended:
http://acronyms.thefreedictionary.com/MOA
You are welcome to believe that Anavex made up its story of how Anavex 2-73 re-connects mitochondria and endoplasmic reticula.
If it's false, as you imply, the SEC needs to learn of this, as this would be a major, confounding, and illegal misrepresentation of the company's major drug candidate, affecting AVXL stock prices, etc.
Of course, there have been no adverse or negating responses from the many neuro-scientists who have scrutinized Anavex presentations, such as this one. No top-line biochemistry or neuron function parties have --- unlike a number of posters here --- shouted expressions of warning and falsehoods regarding the presented and posted Anavex data. The absence of contravening scientific presentations or expressions of such by competent neuroscientists (not high school biology teachers; me) is rather defining.
Again, if anyone would (or could), please post expert opinion or published data telling how Anavex 2-73 simply can't function as the company describes, by re-connecting mitochondria and rough endoplasmic reticula, thereby restoring their normalized functions and cellular homeostasis.
Many, quite understandably, question the degree of my expertise on Anavex neuron chemistry and physiology. But, if I'm all wrong on this, telling exactly what the company itself tells in its posted presentations and scientific meetings presentations, just why haven't any real experts (impartial professional scientists) laid out for all of us the errors of Anavex presentations?
Simple. Those who can comprehend the documented, detailed science of the matter find no errors, no misrepresentations by Anavex.
Each is welcome to follow the perspectives of Ihub posters (of all sorts; me and others), Anavex presentations, and/or true experts. The true experts have been utterly silent regarding the implied misrepresentations of Anavex Life Sciences Corp.
Major Neuron Chemistry Article, mentions sigma-1 receptors.
A comprehensive discourse on the role of sigma-1 receptors, and the role of mitochondrial dysfunction (relating to rough endoplasmic reticular disconnection, among others) can be discerned in this comprehensive paper, “Role of Sigma-1 Receptors in Neurodegenerative Diseases.”
http://journal.frontiersin.org/article/10.3389/fncel.2014.00394/full
Slide 5 here,
http://www.anavex.com/files/Anavex_Presentation_Spring_2016.pdf
shows how Anavex 2-73 restores mitochondrion/endoplasmic reticulum connections and functions.
No other molecule has been shown to be able to restore such mitochondrial function with the degree of safety or efficacy as has Anavex 2-73 in both murine (animal) and human studies (the Australian Phase1/Phase2 clinical trial).
Anavex 2-73 is the only player in this game that can score and win.
With documentation, let us know of any others, please.
None of those sigma-1 agonists fix mitochondria.
Those listed sigma-1 agonists simply do not have the health-restoring capabilities of Anavex 2-73.
Donepezil (trade name Aricept) merely slows or briefly halts the morbid progression of Alzheimer's symptoms. It is in no way a competitor with Anavex 2-73, which (among other things) restores homeostatic mitochondrial/rough endoplasmic reticulum connections, allowing the rough ER to properly fold health-giving neuron enzymes. Aricept does not do this. It is merely a weak, short-lived Alzheimer's treatment that only slows symptomatic progression for a few weeks or months. Death ensues.
None of the other listed sigma-1 agonists restore neuron mitochondrial function, either.
It would be nice to have (as will be the case) Aricept as the accepted Standard of Care for Alzheimer's. Anavex 2-73 clinical data (as already in the Australian study) will show a multitude of lasting, safe efficacies the Standard of Care Aricept cannot match. With Aricept as the competitor, against which Anavex 2-73 will be compared, coupled with validated (Phase 3) clinical data, FDA approval of Anavex 2-73 is assured, to become the new Alzheimer's Standard of Care.
Sigma-1 agonism is not the central factor; rather, it's Anavex's unique sigma-1 agonist that uniquely restores neuron homeostasis (normal biochemical function). There may be many other sigma-1 agonists; but none of them demonstrate restoration of neuron homeostasis. None of them restore normal mitochondrial function. None of them effectively treat Alzheimer's disease. Anavex 2-73 does.
Super Response Factors
A number of patients on Anavex 2-73 have been designated "super responders," where their Alzheimer's symptoms declined and they attained or approached normal cognition, sleep patterns, and other super outcomes.
Why? Several factors could be at play.
First, it may be that Anavex 2-73 simply works extremely well in just a portion of all who suffer from Alzheimer's. If that's so, coupled with the superior safety profile determined in the Australian Phase1/Phase2 trial, the drug will be approved by FDA. In this case, it will be a winner for Anavex Life Sciences Corp, its shareholders, and a good percentage of Alzheimer's victims.
Or, super responses don't occur until a certain, perhaps longer dosing period is experienced. It may well be that when Anavex 2-73 is taken for a year or two, favorable outcomes begin appearing only toward the ends of those lengthy dosing periods.
Related to that is dosage. Anavex 2-73 Alzheimer's efficacy may also be a result of proper dosing sizes or routines. Perhaps dosing needs to be slowly and incrementally increased over lengthy periods to attain super responses.
All of this, I should think, will be determined in the up-coming big Phase 3 study. High chance, I think, the percentage of "super responders" will be much greater, even perhaps universal with new, optimized dosing levels and durations.
Stunning Anavex science (won't change investor perspectives, though).
Thanks for posting this new data-laden Anavex PDF.
As with previous Anavex science data releases, this is loaded with significant documentation of Anavex 2-73's profound efficacies against an expanding number of central nervous system diseases.
I won't deliberate on the exact biochemical mechanisms of Anavex 2-73. Few can understand much of this.
Readers will, with their own due diligence perspectives (skeptical, inquisitive, or open-minded) interpret the Anavex data for themselves.
The most important and revelatory pages of the PDF are pp. 5, 7, 11, 20, and 22.
Well said. The science not a factor.
Those of us who have studied and understand the revolutionary new biochemistry of the Anavex molecules, and how they will revolutionize 21st-century even more than antibiotics did in the last century continue to ponder the continuing ridiculously low share price range of AVXL. What's the deal?
It's clearly this. For retail stock buyers, the unique biochemistry is some pretty complicated "brain science," understood only by brain scientists; beyond the man on the street trying to conduct due diligence.
Institutional buyers, hedge funds, mutual funds, and the like also discount or fail to understand the science. Lots and lots of science for lots and lots of both new and old pharmaceutical companies. Pure science never elevates share prices. Only FDA drug approvals and consequent drug sales do that. Institutional buyers look only for information telling of such regulatory and sales developments. The science be damned. The ability to profitably sell shares and drugs are the only controlling factors being assessed.
So, until Missling or the company can tell some news related to future sales --- such as positive Rett or Alzheimer's trial results --- AVXL share prices will continue to trade in a narrow range; perhaps even trending downward. Projected and anticipated $$$ will be in control, not understandings or applications of the authentic underlying science.
Yes, but would like to see this with Alzheimer's symptoms.
Such as placebo-induced cognition improvements, enhanced sleep, all the other symptoms.
All of this will be resolved in the Phase 3 study. Right now, we are arguing to the question, as it were, of how many angles can dance on the head of a pin.
Fun, but of no real-world consequence. The real deal will be FDA approval of Anavex 2-73 for both Rett syndrome and Alzheimer's (others to follow).
And, because the Australian trial (and extensions) have allowed Anavex officials to detect and optimize dosing levels and frequencies, I believe there is a high chance for early termination of the Phase 3 trial.
The data from the two arms (control and experimental, placebo and real drug) will be blinded. Neither patients nor administering physicians and nurses will know what any of the patients in the trial will be ingesting. Both pills will look and taste the same. Only a computer will know.
And, FDA will, early on, crunch the trial data, internally correlating measured results with what was individually administered. When the blinded computer data reveal that those getting the actual Anavex 2-73 are all stabilized or improved after several months, and those on the non-drug control pill continue to symptomatically decline, in the universal manner of Alzheimer's patients, FDA is ethically obligated to terminate the study and approve the new drug. When computer-crunched data show all or the majority of those taking the real drug are stabilized or improving; while all of those on the disguised sugar pill continue to decline unabated, without any adverse effects (as shown in the Australian trial), medical ethics requires termination of the trial, so as not to further allow the deterioration of the health of the placebo arm of the study.
Instead of a year or more for the study, favorable early computer results from optimized dosing levels and frequencies in the new trial may bring it to an early, ethical termination; with FDA approval quickly to follow.
Such compassionate approval is not out of the question.
Hyper-placebo-osis even bigger than I thought.
Thanks for posting that video segment
It showed that Anavex 2-73's placebo effect not only causes the brain of the treated person to change (fix) dysfunctional neurons in the body, but somehow, jumps across the air and gets into mates and caregivers, causing them to take new, favorable perspectives.
Magnificent, the stunning placebo effects of Anavex 2-73. Just being near a bottle of it may have effects
Maybe that's why Dr. Missling has been so reticent. He, too, has discovered all of this, and knows there is no conventional placebo explanation for all of which that Australian couple related.
A new explanation.
The rather remarkable cognition, soporific (sleep-inducing), and other positive outcomes documented in the Australian Phase1/Phase2 trial have been imputed by some to be elements only of the placebo effect, not authentic drug-induced symptomatic relief.
It is projected that the ensuing full-scale double-blind Phase3 clinical trial will demonstrate that Anavex 2-73's favorable outcomes were merely poorly-controlled or poorly-assessed placebo effects; that the drug offers no authentic or persisting efficacy against Alzheimer’s symptoms. Hence, its approval by the FDA and purchase or ownership in AVXL equities is unwise.
With a profound need for subsequent substantiating in vivo (in the living brain) neurological studies, I’ll then propose this:
Anavex 2-73 has, except for a few, fooled everyone. It’s Central Nervous System treatment efficacies, as determined in transgenic rats, and putatively detected in several dozen Australians, are all just placebo effects.
This is rather stunning, and needs investigation. In fact, just how a rat can perceive or believe it’s being artificially treated with an unknown control substance, while the rats in the cages in the next room, with identical genetically-manipulated (trans-genic) diseases, are being treated with some “real drug” needs investigation. Here’s the answer. I encourage laboratory authentification of this, please.
In fact, Anavex 2-73, may or may not be a restorer of neuron homeostasis and Central Nervous System health (depending, perhaps, on ones perception of the future values of AVXL shares).
In fact, it would then appear that Anavex 2-73 is a new molecule of a new class of high-efficacy drugs. It’s the first drug of hyper-placebo-osis, where it induces such a profound placebo effect on parts of the brain that control emotion and cognitive perception that it causes those brain regions to biochemically suppress toxic chemicals (such as the beta-amyloids and tau tangles of Alzheimer’s), and send previously unknown or undetected nerve signals to all neurons in the body, causing them to re-constitute youthful, healthful homeostasis.
Hyper-placebo-osis is the phenomenon; found only in Anavex 2-73, and perhaps later in its analogues (Anavex 3-71, et al.). All new brain science. Inasmuch as no other mechanism of homeostasis restoration by Anavex 2-73 can be explained by those certain of the placebo explanation, hyper-placebo-osis must be the explanation.
You heard it here first. Anavex 2-73-induced hyper-placebo-osis.
Looking for a moderate-stage Alzheimer's patient who significantly increased cognition scores on a sugar pill, equal to the cognition improvements in the Australian Anavex 2-73 study.
Know of any? How might that work? Any real evidence for placebo-induced cognition improvement in any Alzheimer's trial? Is this notion just theory or fact?
Placebo effect? With an Alzheimer's Trial?
Please tell, when, ever, have any Alzheimer's drug trial shown any sort of placebo effect? When have Alzheimer's patients EVER been able to will-away any of their profound symptoms by the mere thought the new pill they are swallowing (a sugar pill, a placebo) will terminate any Alzheimer's symptom?
Doesn't, can't happen.
Listened to Bloomburg segment. Nothing for DD.
Was nice Dr. Missling was able to appear. Made a useful presentation, at least to the extent of letting listeners know that Anavex Life Science Corp is working on some sort of CNS diseases treatment.
But I didn't hear anything that would have prompted any potential AVXL investors to scrutinize the Web for cogent, supporting information. Just one of many companies pursuing Alzheimer's treatments. Hopes to have the drug in pharmacies in 1.5 years.
End of interview.
Of no consequence, positive or negative. Merely "nice."
Cancer and Mitochondrial Dysfunction.
The Warburg Effect, a putative cause of cancer, is attributed to mitochondria that no longer undergo proper glycolysis, step-by-step breakdown of glucose yielding energy-providing adenosine triphosphate molecules (ATP). Instead, the mitochondria undergo fermentation, failing to use oxygen to efficiently produce ATP. This mitochondrial malfunction causes the cancerous state.
We know that Anavex 2-73 reconnects rough endoplasmic reticula to mitochondria, allowing efficient transfer of ATP to the rough ER, which uses the energy of ATP to properly fold cellular proteins into functioning enzymes, some of which degrade and remove the waste proteins (beta-amyloids, tau tangles) that cause Alzheimer's symptoms.
But I don't see Anavex 2-73 as being able to restore normal mitochondrial respiration (glycolysis). It works on the exterior of mitochondria, and probably doesn't affect internal mitochondrial chemical reactions.
BUT, perhaps the reason cancerous mitochondria fail to work properly is because fully functioning, reaction-controlling enzymes are not present, because of a rough ER/mitochondrial disconnect --- which Anavex 2-73 could restore, thereby making proper mitochondrial enzymes to support normal respiration, glycolysis. According to the Warburg hypothesis, the cell would no longer be cancerous.
Of course, this is something that oncologists will easily study in cancerous rats or mice. Perhaps some Anavex molecule will allow this sort of cancer treatment.
I read with curiosity the postings of corporate lassitude.
No news whatsoever from the corporate offices of Anavex Life Sciences Corp, for some time now. It’s causing some to raise all sorts of questions regarding Anavex’s future.
Those who have these anxieties are welcome to them. Personally, I have no misgivings in my small AVXL position. I knew from the start progression to full FDA approval and widespread medical use of any Anavex drug would be in the (then, a year or so ago) distant future. Still is. No announcements of any kind. Nothing substantive. Nothing forward-looking. Not a word.
Because of the corporate silence, some perceive the Anavex story to be either flawed or hopelessly mired in regulatory and administrative complications. Personally, I do not share those anxieties, for the following reasons.
First, as all here know so well, that the team of Anavex managers, from Dr. Missling on down, have impeccable credentials, both in corporate management and regulatory arrangements. The science, and the PhDs and MDs behind it, is likewise without question.
Why, then, no corporate news? I’m not an insider; I have no useful information to assuage the anxieties of the need-to-see-progress-NOW crowd. But the important, deciding factor for me is this: Corporate officers have the same exact interests for success as we do (or even more so). All of them, too, own AVXL shares, mostly in far larger lots than most of us. So, failure to make progress, failure of the company’s CNS treatment technologies, penalizes the corporate insiders more than it does most of us. Many of those people have their entire professional lives and fortunes bound to Anavex success.
No, these people aren’t sitting around with their feet propped up on seldom-used desks talking about the NBA playoffs or other otherwise inane topics. They are all working hard, to the best of their abilities, to make their AVXL shares valuable.
But still, why no news? We can’t know. But we can be confident that the current corporate silence will play best into Anavex’s hands. The art of the deal, as it were. Anavex is certainly discussing all sorts of collaboration or licensing or other deals with a host of other firms. They are also in close collaboration with FDA officials, working out the details of new, innovative clinical trials.
None of this works if corporate positions and perspectives are floating in the public domain. Big-time negotiations require cunning, cleverness, and privacy. In time, things will be arranged and agreed upon; with favorable corporate announcements. When that happens, the AVXL share price will begin to ascend — and I won’t past any “I told you so...” messages. It’ll all happen when it does, and probably farther into the future than any of us would prefer.
For Anavex, it’s not the Art of the Deal. It’s the many private arrangements (and corporate artfulness) in the arrangement of many, many deals needed to bring Anavex 2-73 to the pharmacy.
Checked the Seeking Alpha homepage.
Didn't look useful or helpful for me (or my readers) in any way. Appears to be merely a compilation of investment advisories, from all the investment advisory usuals.
Saw no place that invited my perspectives; and I don't feel they would be welcomed in any matter. I'm not a long-time, big-time stock investor; merely a common citizen with a useful degree of knowledge and understanding of Anavex's underlying science --- and the ability to communicate such.
I can't see that the management or viewership of Seeking Alpha entertains commentaries from non-investment blokes like me. Saw no invitation or click-button for such.
I'll keep my commentaries solely here, the Ihub site. Everyone must do his own, private due diligence when considering an investment decision. Ihub provides useful commentaries from all sorts of people and resources. Yes, if there were an Anavex website or blog page entertaining reader commentaries, I'd participate. Presently, the only one I'm aware of is this Ihub site. It will have to suffice.
I'm not a big-time stock investor.
I'm a retired school teacher, with limited discretionary funds. I have a few thousand dollars worth of AVXL shares. Satisfied with them, believe they will reap big rewards in the future.
That's a question for each potential AVXL investor.
Everyone, personally, will have to decide for himself the reasons affecting the purchase or holding of AVXL shares.
Stock investing being what it is (seldom with any absolutely sure outcomes), everyone should have skepticisms about AVXL. I have some myself. There is still a chance the company won't be able to arrange or conduct the big, required Phase 3 affirmation trial, and FDA approval would be denied. Outside chance some Big Pharma might buy out the company, so as to keep the drugs off the market, allowing other approaches to go forward. Long chance that the symptomatic relief of Anavex 2-73 against Alzheimer's begins to fade after some long period, causing resumption of cognitive decline. Outside chance Anavex 2-73 might cause some long-term adverse events, some side effects affecting the heart, other organs, or could be carcinogenic. The ponderable list of bad outcomes could be gigantic. Personally, I think all of these are remote.
Consequently, I've not bet my ranch (or entire speculation investment fraction) on AVXL. If I'm all wrong, and Anavex Life Science Corp fails, I will have lost a few thousand dollars, dollars that at the very start I knew were informed speculations. Their loss will not change my financial status in any appreciable way.
But if Anavex succeeds as I believe it will, my financial rewards will be handsome. I continue to sleep well each night. I won't be investing in any pharmaceutical still trying to clear waste proteins. Not a shred of evidence that can safely and effectively work. I've done my due diligence on Anavex, and am confident and satisfied with my small investment.
So, just what should a potential AVXL purchaser do if he intelligently has reservations about the company? That's investment advice, beyond my expertise and experience. Common sense must reign. Don't invest funds you can't afford to lose. Like most equity purchases, AVXL has unknown, uncertain degrees of risk --- likewise with remarkable levels of favorable returns in ensuing years, I believe.
Want a sure-bet investment? Buy some US government bonds. Yield is low, but the return is rather certain. Want some potential big returns, do your own due diligence and search for equities with a promising, evidence-based future. Personally, I think Anavex Life Sciences Corp is just such a company. If it goes bust, I'll continue to live just as I am. My investment here is but a tiny fraction of my net worth.
I wish the best for all, Anavex believers, and Anavex skeptics. Think hard on all of this.
I've never once encouraged the purchase of a single AVXL share by anyone.
That should be a personal decision based upon ones risk, reward, and technical validity perspectives. Those who question in any way the described science of Anavex 2-73 shouldn't even be reading any of the posts on this board. Anavex Life Sciences Corp is a start-up pharmaceutical with no FDA-approved products or their derived revenues.
For those who wish to invest in such a company, the validity and future of the company's proprietary molecules must be confidently ascertained. Without such knowledge or belief, AVXL is just another new-drug crap shoot, which may or may not pan out. Why, might I ask, would anyone without firm confidence in the developing Anavex story have any interest whatsoever in this so-questionable play?
Of course, some institutional (stock fund) buyers have done their research and forked over hundreds of thousands of dollars, taking substantial corporate positions in Anavex Life Sciences Corp. Whether or not any of that influences ones perspectives on Anavex is an open question.
Again, I've never suggested that anyone buy even a single share of AVXL. I've laid out, in clear, concise language the unique neuron chemistry and physiology of the company's sigma-1 receptor agonist, telling how it is able to stabilize or reverse neuron dysfunction. Some might think I'm making that all up, that it's still questionable. I care not. I'm certain of the company's molecular and cellular mechanisms, for which I've taken a personal equity position. That applies only to me, and should not be in any way the basis for anyone else's AVXL buy or sell perspectives.
Everyone should perform his own due diligence. If there is any question, absolutely stay away from Anavex. Don't lose any sleep or dollars with such a questionable equity position. If you have doubts about Anavex, you are in good, otherwise reputable company. Lots of financial advisors have claimed Anavex has no better chance of an Alzheimer's treatment than the many other previous pharmaceuticals who have lost literally billions in trying to solve the problem.
If you've got questions about the validity of the Anavex story or future, this by no means is the place to spend any time reading posts such as mine. How could my info have any due-diligence application? I'm merely a retired biology teacher claiming to understand and convey the elements of the molecular and cytological mechanisms of Anavex 2-73 in the dysfunctional neuron.
Not known yet --- but probable.
Will 2-73 reverse severe and moderate Alzheimer's?
Don't know or follow "Seeking Alpha."
Have you considered writing an article about Anavex on Seeking Alpha?
Those who need to know, know.
I thank several posters for their commendations of my descriptions of the efficacy and safety of Anavex technologies (proprietary molecules) for the eventual successful treatment of neurodegenerative diseases. I'm honored to be able to helpfully tell the powerful Anavex story here. I have rather extensive science writing experiences, and I'm a retired advance-placement biology teacher. I understand the fundamentals of the otherwise complex biochemistry of Anavex drugs, and, to a degree, can explain them to interested audiences.
Importantly, none of the arcane cellular and chemical processes of the Anavex drugs are hidden, mysterious, or un-comprehended by those who need to know. Of course, all of the Anavex principals know the details. But, so now do FDA and potential pharmaceutical collaborators and support groups. All of this may continue to be mystical to common retail equity buyers, institutional buyers, and financial advisors. But none of them will play any roles in Anavex's future successes. Those who know the story will guide its successful conclusion.
Will make Anavex an even bigger success.
:...it is a bit reassuring that other researchers are realizing that there is commonality with the various degenerative diseases: AD, PD, HD, etc.
More of the same, a last century approach.
That article tells the same, failed Alzheimer's treatment story: accumulated waste proteins in neurons cause Alzheimer's symptoms, therefore, the only viable treatment approach is to find some way to extract those wastes.
In fact, Anavex has such a way. Instead of trying harsh chemicals or externally-forced immune responses, all of which have failed, Anavex fixes the problem at its source, at the beginning of the Alzheimer's disease process, not at it's end.
The researchers haven't asked or addressed the real problem: what causes the toxic accumulation of the protein wastes, the beta-amyloids or tau tangles? Instead, they focus on trying to get rid of the wastes after they've accumulated, and will continue to accumulate while the root-cause of Alzheimer's goes untreated.
The root cause is NOT waste protein accumulations. It's the progressive dysfunction of the mitochondrion-endoplasmic reticulum complex. Alzheimer's, along with virtually all of the other geriatric neurodegenerative diseases, is caused by mitochondrial dysfunction. Mitochondria synthesize adenosine triphosphate, ATP, which is the energy-providing molecule for virtually all cellular reactions and processes. Normally, ATP is passed from the mitochondrion to the attached rough endoplasmic reticulum, a layered membrane that, with enough ATP (and other molecules and ions) allows proteins to be properly and precisely folded into fully-functioning enzymes. Some of those enzymes remove and/or degrade normal cell protein wastes, including the neurotoxic beta-amyloids and tau proteins.
In Alzheimer's, the rough endoplasmic reticula become detached from the mitochondria, so they don't receive sufficient ATP. Protein folding is compromised, and waste-clearing enzymes are poorly produced. Toxic protein wastes accumulate, disease symptoms appear.
That's the root cause of Alzheimer's, and Anavex 2-73 effectively, efficiently, and safely re-connects the two organelles, Waste-clearing enzymes are produced once again, and over time (weeks or months, it appears from early clinical results), normal neuron health is restored.
Why, then, do so few Alzheimer's researchers and institutes fail to make this so-sensible approach? Very simple. They know of none, nor have any molecules that can do this. Anavex Life Sciences Corp is the sole proprietor of this revolutionary technology. An independent Alzheimer's research scientist can't place an order for 500 mg of Anavex 2-73 from any chemical supply firm. Anavex owns and develops the molecule and its several important analogues.
The Alzheimer's treatment and prevention game is entirely in the Anavex labs and clinical trials. No one in the business can even imagine how to replicate the process. The clear-the-wastes approach will continue to be the proclamation (as in this article) until Anavex's stunning P3 results shake the Alzheimer's research world.
Superior Anavex management team.
For viewers distressed at the apparent lack of favorable corporate announcements, for those who might tend to believe that corporate officers simply aren’t doing or accomplishing anything, I suggest a detailed reading of the accomplishments of each of the Anavex board members, here: http://www.anavex.com/about-us/management_directors/
Are any of these distinguished fellows the personality types to sit back in their office chairs, prop their feet up on their desks, and argue about some sports team or otherwise waste time?
None of these fellows got to where they are by laziness, lassitude, inattention, or neglect. Each is markedly distinguished and accomplished. Only one, Mr. Skarpelos, fails to have any distinguishing letters behind his name. All he has is a career with various biotech companies and ample financial resources. He’s the biggest Anavex shareholder. It’s in his self-interest that the company succeed.
Not a one of these fellows is failing. In time, we will see the results of their management and development diligence and expertise. Profoundly qualified, each.
Anavex to be a business school case study.
As slow and disguised as corporate developments appear to be, I'm certain that big things are being arranged and are happening behind closed Anavex doors. Herr Doctor Missling and his every-growing body of drug development experts simply are not sitting around twiddling their thumbs, awaiting some external things to happen.
No, the Anavex principals have world-class status and know that at this stage the most important efforts are to get the Anavex picture framed and lighted, for eventual revelation to an appropriate corporate world, the complex of Big Pharmaceuticals, along with supportive and collaborative interest groups (Alzheimer's, Rett Syndrome, Parkinson's support groups, etc.).
All of this has to be done effectively --- and that's not (yet) in the public forum. All matters must first be arranged privately with appropriate parties --- and none of those are we retail Anavex equity investors. For now, we are not in the picture. Our days will come, when Missling et al. have constructed effective corporate collaborations and regulatory approvals.
I contend that, in time, the Anavex story --- how this company revolutionized 21st-century medicine --- will be classic and required reading at all business schools. How could a small group of scientists, with a collection of new molecules cobble together a fully-functioning new Big Phrama company that a) solves so many medical problems, b) reaps great rewards for shareholders, c) saves governments billions upon billions of dollars of health care costs, and d) improves the lives of countless individuals across the world?
All of us here get to watch this story as it slowly (but rapidly, in time) unfolds.
Sleep a factor in Alzheimer’s severity.
New technical report implicates sleep deprivation as a cause or contributor to Alzheimer’s disease. “...research has found that chronic sleep deprivation increases so-called plaques in the brain thought to be a main cause of Alzheimer’s and other dementias.”
Anavex 2-73's suppression of insomnia (apparently universal in the Australian trial participants) may be more than a merely useful go-to-sleep outcome. Sleep, itself, may suppress the onset of Alzheimer’s. Middle-aged insomnia may tip things ominously in the direction of Alzheimer’s. Suppression of insomnia may be but yet another favorable mechanism for Anavex 2-73 against Alzheimer’s.
http://www.telegraph.co.uk/science/2017/05/26/sleep-deprivation-can-cause-brain-start-eating/
Multiple Sclerosis involves demyelination, where the malfunctioning immune system attacks insulating nerve tissues, the myelin sheath, allowing nerve impulses along the nerve to leak out. Like removing the insulation on an electrical wire. Nerve signals "short out."
And, yes, this (as with so many other disease processes) is a form of inflammation, where the immune system attacks normal, good body tissues.
MS therapies attempt to turn down the inflammation, turning down the immune system. But with that, infections and other untoward outcomes can proliferate.
Inflammation a factor in almost all diseases.
Yes, inflammation is a component of most CNS diseases. In fact, 21st-century medical science has come to the conclusion that inflammation, in one form or another, is involved with the vast majority of diseases and conditions.
Whether or not Anavex molecules might rather directly control or suppress such inflammation is unknown to me. I don't recall any such outcomes or references in the good number of Anavex technical papers I have perused.
That's not to claim any Anavex inflammation inefficacy; merely to state I've don't recall any references to the matter.
This does raise the question, however, what new, other diseases and conditions might Anavex molecules treat? Some time ago, the only target disease I was aware of was Alzeimer's. Now, Rett Syndrome is a prime target, closely followed by Parkinson's and other CNS diseases.
We've already conjectured on how Anavex 2-73 might well prove to be a remarkably safe and effective treatment for insomnia (with strong supportive evidence in the Australian trial).
In the Anavex pipeline webpage, there are indications or conjectures that Anavex molecules will treat cardiovascular conditions, psychiatric conditions, and cancers.
The spectrum of Anavex efficacies is yet unknown, but clearly wide.
With a lengthy, large-n Phase 3 Alzheimer's trial (later this year) all sorts of non-target, incidentally good outcomes may be discovered beyond just Alzheimer's symptoms (as were the insomnia results in the P1/P2 Australian trial).
No Technical Analysis
I note with curiosity (but no significance) the recent absence of Anavex TA charts and projections. Not sure (nor don't care) what this means.
AVXL continues to trade in narrow range. I would expect more of the same until substantive corporate news appears. (But I'm a biologist, not a chartist or trader, or anything of the kind.)
No indication I know for Anavex against arthritis.
I haven't seen any technical reports or other information that any of the Anavex molecules might effectively treat any of the various forms or causes of arthritis.
Perhaps this will incidentally show up in future clinical trials for target conditions (Alzheimer's, Parkinson's, et al.).
Given the profound, demonstrated efficacies against so many conditions, it's not inappropriate to hope Anavex may someday have another answer to yet another debility.
So, the tau tangle thing again (any different?).
Merck, perhaps in desperation, collaborates with a Japanese pharmaceutical pursuing a tau protein removal drug. Good luck with that one. How many other Big Pharmas have spent billions testing both beta-amyloid and tau tangle removal drugs? Not a one has been successful in any way.
If this one can work, fine. Chances are slim, however. I'm not buying any Merck shares.
Once again, the target is an end-stage outcome. Beta-amyloids and tau tangles result at the end of the neuron dysfunction processes that cause Alzheimer's. This is where Anavex is so superior. It's drug, Anavex 2-73 treats the initial, first-stage problem, the disruption of the mitochondria-endoplasmic reticula interface. In normal, homeostatic neurons, the mitochondria are attached to the endoplasmic reticula and easily transfer adenosine triphosphate (ATP) to the ER, which allows it to properly fold proteins into fully-functioning enzymes, some of which clear the waste proteins, beta-amyloids, and tau tangles.
Anavex 2-73 fixes things before wastes accumulate, right at the start of the disease process, not the end. No other drug in consideration can do this. Unique, safe, and effective. Anavex 2-73, the eventual Standard of Care for a multitude of geriatric diseases.
Looks favorable for Rett Syndrome
Thanks for the URL.
If the molecule (or analogues) work in afflicted humans as described, the drug looks to be very useful.
Appears that it will work best if administered early on, with Rett Syndrome right at birth, as the drug appears to best treat things during development. Therapeutic efficacy at later ages, when neurons and brain tissues are more developed, may be questionable.
The drug is certainly not a competitor of Anavex 2-73. It works very differently, affecting certain neuron molecules (cytokines, etc.).
One form of the molecule apparently can cross the blood/brain barrier (it can be orally administered). It also is claimed to have a longer half-life (resides in cells longer). All favorable.
But actual therapeutic outcomes, degree of healing, is not mentioned (and presently may not be known).
Hope this can work for Rett Syndrome patients. (I'll still restrict my investments to AVXL.)
Good question --- long term safety.
Falconer, in your opinion are we free and clear from all safety issues?
No mystery.
Does anyone know how they calculated the $17?
No, takes some developed biological knowledge to be able to understand the unique, revolutionary biochemical mechanisms of Anavex 2-73, all of which point to remarkable future successes.
The general market is, by and large, clueless as to Anavex biology. Therefore, no big share price increases until information appears that the general public can understand, such as approval or conduct of new clinical trials. Presently, there is nothing the non-scientific crowd can connect with to AVXL.
In time, the entire world will learn of the Anavex revolution. (But most of us here, will have been in early, persisted, and will reap great rewards.)
Targeting the root cause. It's not beta-amyloid.
The belief that Alzheimer's is caused by the aggregation of beta-amyloid plaques and neurofibrillary tangles is starting to get muddied and the "consensus" scientific opinion is no longer.
More positive Anavex developments.
The ability of Anavex 2-73 to safely, effectively treat an ever-expanding list of Central Nervous System diseases is further revealed by today’s corporate announcement:
http://ih.advfn.com/p.php?pid=nmona&article=74661505
Read the whole article. Count and list the number of CNS diseases for which Anavex 2-73 has shown efficacy. It’s not just Alzheimer’s or Parkinson’s.
I’ve done a bit of reading of technical papers investigating successful Anavex 2-73 treatment of animal-based analogues (transgenic, etc.) of human CNS diseases. That list is even bigger. Beyond CNS diseases are cancers, heart disease, psychiatric conditions, and more.
The safety and magnitude of Anavex 2-73 therapies (and later, perhaps equal or exceeding it by Anavex 3-71) are, as yet, virtually unrecognized by the general investment and scientific communities. Those communities continue to think Anavex 2-73 is but another, destined-to-fail beta amyloid target.
This willful ignorance, however, is not possessed by whatever parties Anavex principals are discussing with potential marketing collaborators. Behind closed doors, experts are fully aware of the revolutionary Anavex molecules, and will act appropriately. We don’t get to monitor those discussions, but the science and clinical data can be understood by a college freshman biology student. No real mystery; just new, unique, and unexpected facts.
And none of this is obscure to FDA officials monitoring Anavex’s progress. The Trump administration’s efforts to bring new drugs promptly to market set Anavex 2-73 in sharp focus, a perfect demonstration drug for this new initiative.
Let’s see how this plays out.