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Made First 2019 Buy
Checked in this morning, saw both the new Scientific Advisory Board Member and the sharply ascending AVXL price. Had some funds sitting in my Schwab account; bought a few dozen. Have a nice paper gain.
I first wondered what created all of the buy-in interest. Then saw the addition of the new guy on the Anavex SAB. I’m a biologist (retired biology teacher; now a researcher with an Ohio university research foundation on a really significant new biotechnology, not related to medical technology, however).
Clear to me guys like Dr. Kaufman don’t align themselves with start-up new biotechs unless they are certain that their participation in the company’s Scientific Advisory Board (SAB) wouldn’t in any way diminish or compromise their otherwise sterling record.
No doubt, before Kaufman signed on with Anavex he scrutinized all of the back of the lab data and information Anavex has about their sigma-1 receptor agonists. With an understanding of those data, Dr. Kaufman signed on. He knows more about the science and prospects of Anavex Life Sciences Corp than any of us outsiders. He determined that his new position with Anavex is not a career risk; rather, an opportunity.
Understanding all of that, I made my AVXL purchase this morning. Will be holding until 2023, at least.
Fine way to start the Anavex 2019 year, for both Dr. Kaufman and those of us who have taken new 2019 AVXL positions.
My Conjecture Exactly
Could it just mean that after taking the drug for awhile the body has repaired itself enough to not require dosing until symptoms worsen again (body/brain go back to pretreatment state)?
Thanks for the Correction
Yes, there were some dose interruptions. Very well.
Eager to see how this might work in the upcoming Phase 3 trials.
Interrupted Anavex 2-73 Dosing
On the recent patent application, it was noted that various dosing regimens involved interruption, temporary termination of Anavex 2-73. Very interesting; inasmuch I find no indication that this occurred in any of the previous human Anavex dosings. It appears that in both the initial Phase 1 dosage and tolerability study in Australia, and with the consequent continuance of that study for many months thereafter the drug was continuously dosed. No interruptions.
Why, now, is the new patent application claiming patent protection for interrupted dosings (at various frequencies and durations)? Why was interrupted dosing not a part of the original Phase 1 study in Australia?
Having no access to all of the relevant pharmacokinetics and pharmacodynamics of the matter, the following is only speculation. But worthy of pondering.
Has it been discovered that, in fact, Anavex 2-73 (and its intracellular metabolites, perhaps) do persist and remain therapeutically active for some time after initial dose loading periods? Does this unique sigma-1 receptor agonist bind to good-fit receptor sites in the neuron and remain both attached and remain active for some time thereafter?
If that is so, there is no need for continuous, daily dosings. Administer a loading dose, which chemically binds to appropriate receptors, where it remains active for some time. Then, re-dose only after the loading dose is slowly cleared or lost.
If this is, indeed, the now-best administration routine of Anavex 2-73, what might be the implications? The next big question is the duration of activity of initial, loading doses. Might, perhaps, those extend for not days, but both in lengthy periods of weeks or months?
Then, might activity periods increase with subsequent dosings? Finally, after a course of interrupted dosings, at increasing intervals, might Anavex 2-73 so effectively restore homeostatic processes that subsequent doses are unneeded? Neuron organelle architecture and protein and enzyme chemistry are rather permanently restored?
This can make sense with the understanding that Parkinson’s and Alzheimer’s are both (except in rare cases) geriatric in onset. Takes decades for things to go wrong in the affected neurons. Twenty-three year olds seldom get either disease (and when they do, aberrant genetics are involved). It can take decades for neurons to “wear out,” or otherwise become malfunctioning. Can Anavex 2-73 put things back together in youthful, healthful configuration, allowing lengthy periods of subsequent un-dosed therapy? The functionality of interrupted dosing (as in the patent application) implies that such is the case — at least for short periods.
As with all of the other exteriorly unknowns about the Anavex molecules, this surely has been examined on transgenic, aged lab rats with genes for Parkinson’s and Alzheimer’s. Might such murine data have prompted the patent application; gaining further intellectual property protection for Anavex Life Sciences Corp.?
Bought Some Myself Today
Had a few dollars left in my budget, discretionary funds. Bought a few hundred AVXLs this morning; have for the day a 12.6% on-paper gain.
In my target year (2023), let's see how those turn out.
1.28% Of All Shares Today
My sometimes questionable arithmetic shows about 1.28% of all AVXL shares were traded today. Uncharacteristically large percentage.
And the day-long trend was generally upward.
Next week, too?
Have the majority of shareholders with doubts now liquidated their positions, leaving only us long-and-strongs holding the bag (as it were)?
OFP, Thanks For Pointing Out The Error — Corrected
Here are the base metrics:
5,700,000 Americans have Alzheimer’s.
https://alz.org/media/Documents/alzheimers-facts-and-figures-infographic.pdf
Approximately 44 million people worldwide living have Alzheimer’s disease or a related dementia.
https://alzheimersnewstoday.com/alzheimers-disease-statistics/
An estimated seven to 10 million people worldwide are living with Parkinson’s disease.
Approximately 60,000 Americans are diagnosed with Parkinson’s disease each year,....
http://www.parkinsonassociation.org/facts-about-parkinsons-disease/
...a global study of the impact of a wide range of health conditions published in 2017, estimated that just over 6 million people across the world are currently living with Parkinson’s.
https://medium.com/parkinsons-uk/how-many-people-have-parkinsons-61d04979a770
So, for these two diseases, across the world, there are about 50 million potential Anavex patients — with far greater numbers as world populations emerge into old age.
Ok, let’s assume that Anavex will be used to treat only 5% of the global populations of these two diseases. That’s a patient population of 2.5 million.
Big unknown here. How much will each patient (or her government or health insurance company) pay for a year of Anavex treatment? How much will Anavex charge? We can only guestimate.
At $5 a day, that’s an annual per-patient revenue gain by Anavex Life Sciences Corp about $1800. At $10 a day, about $3600.
To find gross annual corporate revenues, multiply those per-patient revenue numbers times the number of patients treated. Lots of zeros.
Estimating drop-downs (if there will be any) for dividends is very hazy. If dividends are 10% of gross corporate revenues, multiply them times 0.1. For per-share dividends, divide that metric by the number of outstanding shares (presently ~46.5 million).
Then, presume some price/earnings ratio, and multiple the dividend price by that datum. That gives an estimate of the share price. PE ratios are commonly (now), as far as I can tell, from 1/10 to 1/25. (I’m a biologist, not an astute student of stock investment details — correct me on any of this, please.)
Of course, all of these metrics are hazy; can vary widely. Punching the numbers will require high-range and low-range lines for each.
Nonetheless, even at the lowest range, say, Anavex treating only 2.5 million people a year, at an annual pills cost of $5/day ($1800 per year), this yields gross annual corporate revenues of $4,500,000,000. That’s $4.5 billion.
But maybe therapeutic doses will cost only $0.50 per day (not $5.) With that, annual per-patient revenues would be about $180. With 2.5 million patients per year, corporate revenues would be only $450,000,000; four and half million dollars.
Of course, if Anavex never gets a drug to market (the clinical trials all fail), all of the revenue numbers will be zero. Don’t invest dollars in AVXL you can’t afford to lose. Informed speculation, best only with discretionary dollars — all dependent upon successful clinical trials results (which appear from extensive murine studies to be very likely).
(Now, was that “pumping?”)
OOPS!
Billions, not trillions.
(Darned zeros.)
OK, The Numbers.
Here are the base metrics:
5,700,000 Americans have Alzheimer’s.
https://alz.org/media/Documents/alzheimers-facts-and-figures-infographic.pdf
Approximately 44 million people worldwide living have Alzheimer’s disease or a related dementia.
https://alzheimersnewstoday.com/alzheimers-disease-statistics/
An estimated seven to 10 million people worldwide are living with Parkinson’s disease.
Approximately 60,000 Americans are diagnosed with Parkinson’s disease each year,....
http://www.parkinsonassociation.org/facts-about-parkinsons-disease/
...a global study of the impact of a wide range of health conditions published in 2017, estimated that just over 6 million people across the world are currently living with Parkinson’s.
https://medium.com/parkinsons-uk/how-many-people-have-parkinsons-61d04979a770
So, for these two diseases, across the world, there are about 50 million potential Anavex patients — with far greater numbers as world populations emerge into old age.
Ok, let’s assume that Anavex will be used to treat only 5% of the global populations of these two diseases. That’s a patient population of 2.5 million.
Big unknown here. How much will each patient (or her government or health insurance company) pay for a year of Anavex treatment? How much will Anavex charge? We can only guestimate.
At $5 a day, that’s an annual per-patient revenue gain by Anavex Life Sciences Corp about $1800. At $10 a day, about $3600.
To find gross annual corporate revenues, multiply those per-patient revenue numbers times the number of patients treated. Lots of zeros.
Estimating drop-downs (if there will be any) for dividends is very hazy. If dividends are 10% of gross corporate revenues, multiply them times 0.1. For per-share dividends, divide that metric by the number of outstanding shares (presently ~46.5 million).
Then, presume some price/earnings ratio, and multiple the dividend price by that datum. That gives an estimate of the share price. PE ratios are commonly (now), as far as I can tell, from 1/10 to 1/25. (I’m a biologist, not an astute student of stock investment details — correct me on any of this, please.)
Of course, all of these metrics are hazy; can vary widely. Punching the numbers will require high-range and low-range lines for each.
Nonetheless, even at the lowest range, say, Anavex treating only 2.5 million people a year, at an annual pills cost of $5/day ($1800 per year), this yields gross annual corporate revenues of $4,500,000,000. That’s $4.5 trillion, not billion. Pretty big number.
But maybe therapeutic doses will cost only $0.50 per day (not $5.) With that, annual per-patient revenues would be about $180. With 2.5 million patients per year, corporate revenues would be only $450,000,000; four and half million dollars.
Of course, if Anavex never gets a drug to market (the clinical trials all fail), all of the revenue numbers will be zero. Don’t invest dollars in AVXL you can’t afford to lose. Informed speculation, best only with discretionary dollars — all dependent upon successful clinical trials results (which appear from extensive murine studies to be very likely).
(Now, was that “pumping?”)
Persistence of Anavex Treatment
...the effect of A2-73 persist(s) for a period without dosing.
I’ve Done My Own Private Spreadsheet On This
[Is it possible]...these drugs will achieve mega-blockbuster drug status with sales of at least several billion dollars per year?
Thanks, But I Was Incomplete.
Thank you, again, falconer, for that comprehensive description (I was expecting a few sentences).
Treasuries Have Profound Evidence Of Efficacy
Need evidence of a profitable mechanism of action before investing hard-earned dollars?
Don’t be investing in any start-up biotech. Far too risky. Until proper clinical trials results are released, no way to accurately predict exact clinical outcomes — or corporate sales success.
Go the best, most reliable, for-sure route. Put your investment dollars in US Treasuries. They have a for-sure, demonstrated, legally-mandated mechanism of action. They yield a known-before-purchase, guaranteed percentage increase (interest rate).
Three-month Treasuries are now being bought with a 2.43% yield. Six-month Treasuries are yielding 2.54%. Nine-monthers are at 2.59%. Go way out, to a year, and gain 2.62%
How could AVXL compare? Mechanism of action unknown. No human trials results of any confidence revealed.
Why waste time here pondering the risky imponderables of Anavex Life Sciences Corp? Get smart. Invest in no-risk, for-sure US Treasuries. No comparison.
Make 2019 profitable, with no risk.
“Cellular Homeostasis” Is Complex
Is this a description of the cellular homeostasis process or, at least, a part of it?
Perfect Fit
Neurons naturally undergo a cellular “cleaning system” that relies on several proteins, including one called BAG3,...
How Will Australian and Spanish Media Report Anavex?
Yes, once Parkinson’s patients in Spain, and Alzheimer’s patients in Australia begin to start popping Anavex-supplied pills each day, what will be the reaction of investigative reporters?
Some will be thinking that because they are professional, trained, skilled reporters, they will necessarily respect and honor the created blindedness of the clinical trials. “Report on the clinical trial centred over at the hospital? Oh, no. Won’t be doing any of that. It’s a double-blinded clinical trial. No one; patients, doctors, nurses, family members; are to know whose taking what during the entire trail period. It would be so wrong and awkward for any of us reporters to start asking delicate questions about that Anavex drug. We’re professionals.”
Or, “Editor, there are rumours of patients of doctors at the geriatrics ward of the local hospital being able to now feed themselves, and carry on thoughtful discussions with nurses and staff. One orderly said several patients with dementia taking some drug seem to be getting better. Can you find the truth of these rumours?”
“Oh, no. I’ve instructed my reporting staff to stay away from that hospital. We don’t want to get ourselves involved in the spurious reports of remarkable new behaviors of dementia patients over there. Only physicians, after a drug trial had ended, should comment on such things. We'll wait for their reports.”
That’s they way reporters and news writers see things, isn’t it? Won’t be a shred of clinical outcomes news until Anavex formally report them at a neurology conference in 2021 or 2022. After all, all three of the trials are double-blinded. No one; patients, doctors, care givers, or family members know whose getting the drug and whose being legitimately fooled by taking a starch pill of exactly the same size and color as the Anavex pill.
That nails it, thoroughly. Nothing will be known too early. Everything in order; well-controlled.
(And, say, have I got a hot stock for you to buy?!)
Looking Ahead, to December 2023
As I’ve stated, my Anavex investment assessment time frame lasts until 2023. I believe it may take until then to determine if my moderate purchase of AVXLs is profitable or a loss.
So, here are statements I’ll be glad to post in the last week of December, 2023.
If AVXL has lost all value; has no prospect of attaining my share buy-in values, I’ll post this statement:
“Well, 2023 is coming to an end. Unfortunately, after holding my AVXL position for over eight years, it has been a total loss. Originally, I purchased a small position, believing from both murine and early human trials data that Anavex Life Sciences Corp had unique sigma-1receptor agonists that would provide useful treatments for various human central nervous system diseases. However, comprehensive human trials failed, the company failed to attain regulatory approvals to sell their drugs anywhere in the world; it is now a bust.
Fortunately, I didn’t bet my ranch on the investment endeavor; used only budgeted discretionary funds. My best hope is that some new chemotherapeutic approach to CNS diseases might eventually appear. The real loss has been for those suffering from Rett syndrome, Parkinson’s dementia, and Alzheimer’s. Here’s hoping for effective, new treatments.”
Or, if Anavex has proven to be a CNS treatment and commercial success, my statement in December 2023 will be something to this effect:
“It’s been now over eight years since I took my small AVXL position. At the start, for over three years, there was minimal human evidence of treatment success. But, then, in 2019, human trials data concerning Anavex 2-73 against Rett syndrome, Parkinson’s dementia, and Alzheimer’s disease began to appear. Today, those three (and other) human CNS diseases are being successfully prevented and treated by Anavex. Neurology is no longer the same.
And neither is my brokerage account. I’ve determined to continue to hold all of my AVXL shares, now approaching $400 each in value. They will go to my children. The dividends are more than adequate for me. And, now, with the impending approval of Anavex 3-71 and the other new sigma-1 receptor agonist drugs in the still-emerging Anavex pipeline, targeting now many diseases and conditions beyond those of the CNS, the Anavex share price on the NYSE continues to ascend.
So glad I didn’t listen to those distant naysayers, who thought efficacy data for the Anavex molecules were invalid and insufficient. For my career, I taught biochemistry, cytology, etc. My knowledge of those cogent topics allowed me to see the potentials of Anavex—now realized. My best to all; especially to those who formerly would have been suffering from the now-conquered CNS diseases. Thank you, Anavex.”
___________
Which of those will it be?
I have no understanding (nor interest) in Biogen's potential use of Anavex technologies.
Not a matter I can comment on.
Well, There Is A Bit of "Evidence"
Thanks for posting these published articles telling of the science of Anavex. In fact, there are others, too.
As with other Anavex investors, the papers you listed provide sufficient evidence for a moderate AVXL position.
Of course, those who find these many studies to be inadequate should invest their discretionary dollars in US treasuries. A sure and certain (albeit small) return. Not risky, like Anavex.
For some, you just can't be too risky with hard-earned dollars. AVXL is certainly not for the risk-averse.
Yes, Just How Well Will Things Turn Out?
...invest accordingly... and see how things turn out.
Trial results in 2019 will tell the entire story, won't they?
Differing Molecular Architectures and Functions
...why A2-73 may give better results?
“Preclinical Drugs Are Too Risky, Period”
With your stated trepidations, could you illustrate for us any sort of pre-clinical drug, absent definitive Phase 3 clinical trial data that you would ever recommend investing in?
Would it be accurate, then, to understand that you simply would never invest in any pharmaceutical equity that hasn’t already gained regulatory approval for sale and medical use? Until that occurs, investors such as yourself cannot know with sufficient certainty any of the various matters of a drug’s success: a) safety, b) tolerability, c) effective dosage levels, d) levels and forms of treatment efficacies, e) precise understanding of a drug’s biochemistry and mechanism of action, f) size of the drug’s market, and g) acceptability and frequency of prescription by practicing physicians (market use).
Fair to say? “Nope, unapproved drugs, without established records of treatment, are simply too speculative for retail investors to risk their equity investment funds on. Simply, stay away from investments like Anavex Life Sciences Corp. You can’t know enough about their potential drugs to be safe and secure with your hard-earned dollars.”
Pretty much sums it up, does it not?
Only Trials Results Matter
...the trials have to proceed,....
Anavex Results in Murines and Humans Are Unique
In light of the above, please point to any aspect of your post you still feel is unique...I don't believe there is anything.
Review: The Unique Anavex Mechanism of Action
The future of Anavex Life Sciences Corp depends upon its ability to successfully market any of its several pipeline drugs against various central nervous system (CNS) and other diseases. For commercial marketing (and revenue generation) several matters must be resolved.
Presently, positive therapeutic outcomes, absent negating adverse events (“side effects”), must appear in any of the three, being-arranged clinical trials of the lead drug candidate, Anavex 2-73. Proper, well-constructed clinical trials of the drug against three CNS conditions are being arranged. In 2019, the drug will be tested against Rett syndrome, a debilitating nervous system condition of young girls. Tests of Anavex 2-73 in mice with Rett syndrome pathologies show very promising therapeutic results, absent any significant adverse effects. Various manifestations of Parkinson’s disease are being clinically assessed. In the largest, most lengthy clinical trial (in Australia), Anavex 2-73 will be used to treat 300 patients with Alzheimer’s disease, in two 150-patient dosage-level arms. A third arm of 150 patients will be the control (blinded with a starch pill).
Should therapeutic results be positive in any of these three CNS conditions, Anavex 2-73 will gain regulatory approval for commercial use. The successful future of the company would be assured.
But successful Anavex therapies depend upon two things: a) sufficient absence of debilitating, negating adverse events, and b) therapeutic outcomes that equal or surpass existing standard of care (SOC) drugs.
In both murine (lab rodent) tests and preliminary human clinical trials, rates and severities of adverse events have been low. No indications either in rodents or humans that Anavex 2-73 at therapeutic dosages causes side effects of any consequence. This is uncommon in neuroactive drugs.
The matter of greatest importance, of course, is therapeutic efficacy. Does Anavex 2-73 yield desirable therapeutic outcomes? That is the primary question to be resolved by the three clinical trials getting underway.
Those results will be positive only if the drug can provide a unique MOA that creates or restores normalized nerve function(s). To understand how this is likely to happen, consider Anavex 2-73's unique chemistry inside malfunctioning neurons (nerve cells).
First, understand that the majority of nerve-based diseases involve or are caused by dysfunctional mitochondria. The majority of CNS diseases involve dysfunctional mitochondria. Very simply, but very profoundly, create or restore normalized mitochondrial function and nerves will function normally. The disease state is obviated.
How, then, might Anavex 2-73 accomplish this otherwise heretofore unattainable outcome?
In fact, if mitochondria themselves fail to function, a neuron with them simply dies. Primarily and essentially, mitochondria extract energy from several intracellular molecules (primarily the simple sugar glucose) and transfer it to created adenosine triphosphate (ATP) molecules. The generated ATPs then move to other parts of the neuron, where they power virtually all of the essential chemical reactions. A phosphate ion is popped off the ATP, creating a low-energy adenosine diphosphate (ADP), and a high-energy phosphate ion. The available bond energy of that released phosphate powers all of the other energy-requiring reactions in the cell. That’s the reason mitochondria are called the “powerhouses of the cell.”
But more specifically, in the case of the unique MOA of Anavex 2-73, a second cellular structure is involved, the endoplasmic reticulum. Endoplasmic reticula (ERs) take up significant quantities of ATP from the immediately adjacent, connected mitochondria, and use the energy in the ATPs to power the precise, complicated folding of strings, polymers of amino acids to synthesize essential catalytic proteins, cellular enzymes.
These enzymes control virtually every chemical reaction within a neuron. Enzymes are like door keys, with precise architectures that either connect chemical feedstocks, or conversely, unlock or break them apart. If the proteins of essential enzymes are improperly folded, essential chemical reactions within the neuron don’t occur; disease results.
And such is the case with Alzheimer’s. With the most exceptional occurrences, Alzheimer’s doesn’t set in until middle or geriatric ages. Before, nerve enzymes are properly shaped and nerves function normally. But with age (perhaps also mediated by other factors), the chemistry of neurons fails. Normal protein wastes (such as beta-amyloids and tau tangles) are no longer efficiently cleared. Accumulation of these then disrupt the transmission and receipt of nerve impulses. The CNS no longer functions well. Memory, in particular, is impeded and disrupted.
Now, to the point, where and how the unique mechanism of action of Anavex 2-73 can effectively treat the accumulated nerve protein wastes in nerves.
Anavex 2-73 is a sigma-1 receptor agonist. Within neurons (and other cells), there are sigma-1 receptors, particular proteins on the endoplasmic reticula. Among other things, the sigma-1 receptors modulate, control the release of Ca2+ ions. Precise control of calcium ion transport between attached ERs and mitochondria is required for normal neuron function, including production of ATP.
ERs must receive adequate ATPs from the adjacent, attached mitochondria to power the precise folding of proteins into properly-functioning enzymes. Insufficient ATPs or improper concentrations of calcium ions in the endoplasmic reticula prevent the synthesis of functioning enzymes. This is pathogenic (disease-causing). Alzheimer’s or other CNS diseases appear.
Uniquely, Anavex 2-73 agonizes, promotes proper sigma-1 receptor function. With that, proper, functional enzymes are produced by the ER; normalized neuron health ensues.
All of this is “homeostatic,” creating “homeostasis” within the neuron (and nerve). A multitude of chemical and organ processes within the body involve requisite “homeostasis.” “Homeo-“ means “same.” “-stasis” means “state.” The same-state condition.
Chemicals, especially those in cells, tend toward de-energized, fully-reacted states. That’s the death state. Living bodies and cells continually work against those chemical proclivities, with a multitude of homeostatic processes. If the body gets cold, the nervous system signals to the thinking parts of the brain to put on a coat. If too hot, the opposite. Thermoregulation, in all forms, is a homeostatic process. Homeostasis — the bringing back of some otherwise varying process to a normal, “same,” unvarying state
Uniquely, and with such promise, Anavex 2-73 restores neuron homeostasis. Calcium ion transport is moderated and controlled; sufficient ATP diffuses or is transported to the ER so as to allow normalized, healthful production of properly-folded enzymes that then modulate and control healthful chemical reactions in the neuron. Beta-amyloid and tau protein wastes are enzymatically cleared before they disrupt normal nerve and brain function. Neuron homeostasis is restored. The CNS disease state is obviated.
There are no existing drugs that have this MOA, nor are able to restore neuron homeostasis.
Apples and Anavex
Given the 99.% failure rate,....
Bacopa extract and cognition.
Xena, yes, Bacopa extract, from the plant Bacopa monnieri, has a wide number of cognition benefits. I pop this one, too. I'm mentally sharp as a tack.
(But can't take the time here to lay out the pharmacognosy of the plant.)
Later (or elsewhere).
Later.
Biostock, thanks for the accolades. 'Tis an honor to share information on the important science of Anavex Life Sciences Corp.
Am tied up in some unrelated biology projects; will try to post another summary of sigma-1 receptor agonist-induced homeostasis in neurons this afternoon or tomorrow. Failure to understand that obviates an understanding of the profound Anavex future.
Thanks. Later.
Again, A Vitamin D Factor?
...the countries where AD is broken out by gender and men have the highest incidence (not higher than women but highest in the world) are Muslim countries
Low VitD status was associated with accelerated decline in cognitive function domains in ethnically diverse older adults, including African American and Hispanic individuals who exhibited a high prevalence of VitD insufficiency or deficiency.
Could it be an induced cholecalciferol deficiency?
...the incidence of dementia and Alzheimer’s disease is significantly lower for Africans in Nigeria than for African Americans in Indianapolis, for example—up to five times lower.
Chronic Use and Efficacy of Anavex 2-73
Anavex may be the 21st century version of "pencillin."
What’s This Imputed “Dilution” Factor?
First, the company contends that it has, on hand, the funds required to conduct the three trials. Why a presumption of dilution? Is the company misrepresenting its financial position? The SEC will take great exception, if so. (And Dr. Missling will be in great jeopardy.)
But if extensive in-house, yet unrevealed murine tests show high efficacies against the three central nervous system conditions being clinically assessed (Alzheimer’s, Parkinson’s, and Rett syndrome), coupled with the on-hand resources to complete the three trials, they will allow the fastest approval (in some country) to begin commercial drug sales for three (not one) medical populations.
If the company has sound evidence of efficacies in transgenic murines (with human CNS disease genes), and can conduct all three clinical trials simultaneously, why postpone trials for distant regulatory approvals? As the Australians would say, “Get ‘em done!” Get the Anavex sigma-1 receptor agonists on pharmacy shelves as soon as possible.
As a small-time AVXL shareholder, I favor that.
An Efficacy Search?
But little efficacy which is why missling [SIC] keeps adding trials
Mitochondria Not From Viruses
...mitochondria are posited to have come from viruses....
A Real “Catalyst”
Partnership agreement would be a catalyst.
We Are Still Waiting.
Experts love to shoot holes in others' work....
Sleep Is An Essential Neural Waste-Clearing Process
Normal physiological processes, virtually all of them, produce waste side products. With accumulation, they are toxic. (Think not, try to hold your breath for 5 minutes.)
In the last few years, abundant evidence has been collected showing that a major function of sleep is to clear wastes throughout the body, but particularly in the central nervous system and the cells therein. Chronic (long-term), inadequate clearance of brain wastes negatively affects a host of CNS functions. Various CNS diseases can ensue.
It wasn’t by inadvertent or curious happenstance that Anavex included positive sleep outcomes from Anavex 2-73 therapy in their patent. They know full well the favorable implications and outcomes that Anavex 2-73-induced sleep will therapeutically yield.
Sound, deep, ample sleep, with rapid-eye-movement (REM) intervals, is not merely pleasant. It’s crucial for mental and nervous system health. The soporific effects of Anavex 2-73 will prove highly significant, with broad therapeutic applications. Watch. Anavex insiders already know (and have gained intellectual property rights protection on the matter).
http://www.abc.net.au/science/articles/2013/10/18/3872071.htm
Well and Good, But Very Preliminary
The new drug, which apparently must be administered in situ, in the brain (a brain surgery), appears to induce the growth of new, properly-functioning brain cells that work around malfunctioning cells. With that, an enzyme that produces gamma-aminobutyric acid (GABA) is facilitated. GABA can then be produced. It turns down the nerve hyper excitability causing various Parkinson’s symptoms. Well and good.
But how long will the new cells remain unaffected by the pre-existing Parkinson’s disease state? Preliminary data appear to show some degree of survivability and function. But how long will that continue. Natal (from birth) neurons first became disabled by Parkinson’s. What will prevent the new ones from that eventual fate? If it takes, say, 50 years, no problem. If it’s five years, two brain surgeries every decade, then.
Should this drug prove efficacious and safe in long-term phase 3 studies (or, perhaps even now), it should gain regulatory marketing approval from FDA. But even with that, which Parkinson’s therapy would you wish for a close relative, one that requires periodic (or even just-once) brain surgery, or a daily pill that while taken provides continuing suppression of symptoms (the Anavex outcome)?
(Off Topic – Regarding Vitamin D)
Here are a number of PubMed articles substantiating vitamin D suppression of influenza and respiratory infections.
Few studies, however, have been conducted using adequate supplementation, in the realm of 5000 IU per day. This article is a good start. Then check the PUBMed references below:
Informative Article:
https://www.vitamindcouncil.org/newsletter-epidemic-influenza-and-vitamin-d/#.W_1qIvZFyCg
PubMed articles:
The role of UV radiation and vitamin D in the seasonality and outcomes of infectious disease.
“...influenza A virus, Mycobacterium tuberculosis and human immunodeficiency virus type 1, have strong evidence to support their interaction with vitamin D”
https://www.ncbi.nlm.nih.gov/pubmed/28078341
Indoor Staying During Winter Season Makes People More Susceptible to Flu.
“Formulation of policy regarding vitamin D supplementation in diet for people such as elderly and with low sunlight exposure is hereby recommended. It will be beneficial to reduce influenza related morbidity and mortality during winter season.”
https://www.ncbi.nlm.nih.gov/pubmed/27426715
An update on the association of vitamin D deficiency with common infectious diseases.
“Over the last decade, an increasing body of evidence has shown an association between vitamin D deficiency and an increased risk for acquiring several infectious diseases, as well as poorer outcomes in vitamin D deficient patients with infections. This review details recent developments in understanding the role of vitamin D in immunity, ...”
https://www.ncbi.nlm.nih.gov/pubmed/25741906
Vitamin D: a new anti-infective agent?
“An association has been established between low levels of vitamin D and upper respiratory and enteric infections, pneumonia, otitis media, Clostridium infections, vaginosis, urinary tract infections, sepsis, influenza, dengue, hepatitis B, hepatitis C, and HIV infections. Accumulating evidence suggests that 1,25-dihydroxyvitamin D3 exerts protective effects during infections by upregulating the expression of cathelicidin and ß-defensin 2 in phagocytes and epithelial cells. Vitamin D may be acting as a panaceal antibiotic agent and thus may be useful as an adjuvant therapy in diverse infections.”
https://www.ncbi.nlm.nih.gov/pubmed/24593793
Vitamin D for prevention of respiratory tract infections: A systematic review and meta-analysis.
“RESULTS: Events of respiratory tract infections were significantly lower in vitamin D group as compared to control group....
https://www.ncbi.nlm.nih.gov/pubmed/23326099
CONCLUSION: Vitamin D supplementation decreases the events related to respiratory tract infections.”
https://www.ncbi.nlm.nih.gov/pubmed/23326099
Translating the role of vitamin D3 in infectious diseases.
"Vitamin D(3) affects both the innate as well as adaptive immune responses. Epidemiological studies have established that vitamin D(3) deficiency plays an important role in tuberculosis (TB) and viral influenza prevalence as well as susceptibility to active disease in TB. Vitamin D(3) status has been associated with the clinical course of HIV infection and drug interaction with anti-retroviral therapy."
https://www.ncbi.nlm.nih.gov/pubmed/22304022
Vitamin D status has a linear association with seasonal infections and lung function in British adults.
“The aim of the present study was to investigate the relationship of current vitamin D status (measured by 25-hydroxyvitamin D, 25(OH)D) with respiratory infections and lung function. ... Each 10 nmol/l increase in 25(OH)D was associated with a 7 % lower risk of infection (95 % CI 3, 11 %) after adjustment for adiposity, lifestyle and socio-economic factors. For FEV1 and FVC, each 10 nmol/l increase in 25(OH)D was associated with 8 (95 % CI 3, 13) ml and 13 (95 % CI 7, 20) ml higher volume, respectively, after controlling for covariates. ... In conclusion, vitamin D status had a linear relationship with respiratory infections and lung function.”
https://www.ncbi.nlm.nih.gov/pubmed/21736791
The seasonality of pandemic and non-pandemic influenzas: the roles of solar radiation and vitamin D.
“In temperate latitudes even pandemic influenzas often show a clear seasonality. The data support the hypothesis that high fluences of UVB radiation (vitamin D level), as occur in
the summer, act in a protective manner with respect to influenza.”
https://www.ncbi.nlm.nih.gov/pubmed/21036090
Serum 25-hydroxyvitamin d and the incidence of acute viral respiratory tract infections in healthy adults.
“CONCLUSIONS/SIGNIFICANCE: Maintenance of a 25-hydroxyvitamin D serum concentration of 38 ng/ml or higher should significantly reduce the incidence of acute viral respiratory tract infections and the burden of illness caused thereby, at least during the fall and winter in temperate zones.”
https://www.ncbi.nlm.nih.gov/pubmed/20559424
Randomized trial of vitamin D supplementation to prevent seasonal influenza A in schoolchildren.
“CONCLUSION: This study suggests that vitamin D(3) supplementation during the winter may reduce the incidence of influenza A, especially in specific subgroups of schoolchildren.”
https://www.ncbi.nlm.nih.gov/pubmed/20219962
Epidemic influenza and vitamin D.
“Vitamin D deficiency predisposes children to respiratory infections. Ultraviolet radiation (either from artificial sources or from sunlight) reduces the incidence of viral respiratory infections, as does cod liver oil (which contains vitamin D). An interventional study showed that vitamin D reduces the incidence of respiratory infections in children.”
https://www.ncbi.nlm.nih.gov/pubmed/16959053
Vitamin D supplementation reduces occurrence of acute respiratory infections
“A new clinical trial published in the Journal of the American Geriatrics Society found that vitamin D supplementation acute respiratory infections (ARI) in nursing home residents. The researchers aimed to determine whether vitamin D supplementation had an effect on respiratory infections among 107 nursing home residents. A total of 55 participants received high doses of vitamin D monthly (averaging between 3,300-4,300 IU/day), and 52 participants were given lower monthly doses (averaging between 400-1000 IU/day). The participants were assessed over a period of 12 months.”
https://www.vitamindcouncil.org/vitamin-d-supplementation-reduces-occurrence-of-acute-respiratory-infections/#.W_1oPPZFyCg