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There Is One
Exactly. Common Sense Reveals.
If the clinical results of the Australian study were negative, if participants didn't perceive symptoms continuing at baseline, or better, why would they have elected or partitioned to continue taking Anavex 2-73?
The continuing symptomatic deterioration typical of virtually all Alzheimer's cases would have been apparent to both participants themselves, and to their care-givers. No sense continuing to pop a pill each day that hasn't produced visible and perceivable symptom stabilization or actual improvement.
Real people reveal real truths.
Histone Deacetylases Not Comparable to Anavex
A complex subject; upon which I will only touch the surface.
HDACs are histone deacetylases, enzymes (properly-folded proteins, as it happens) that remove acetyl groups from chromatin, thereby exposing naked DNA (genes) to make enzymes.
Chromatin is a DNA/RNA/protein complex that folds and encloses DNA. DNA molecules are lengthy, and if allowed to float independently in the chromosomes would become tangled and subject to breakage (among other untoward biochemical outcomes).
DNA is condensed in the chromatin complex in chromosomes, where its genetic integrity is protected.
But while thoroughly enclosed in the chromatin sheath, the genetic information of the DNA, the genes, cannot be read or expressed by the cell. For genetic expression, the DNA information must first be transferred to ribonucleic acid, RNA, a process called transcription (“writing across”). The genetic information, which codes for the eventual production of a specific reaction-controlling enzyme (a folded protein), creates a new RNA sequence.
Then, the RNA is enzymatically split off from the HDAC-exposed DNA strand, and the genetic info is taken by the mRNA (messenger RNA) to an extremely complex organelle, the ribosome. Here, the mRNA strand is fed through the ribosome, and specific amino acids are connected in exact sequence, thereby making exact, precise amino acid sequences. Genetic info goes from DNA to RNA to a specific amino acid sequence.
The amino acid sequences, finally, are processed in the rough endoplasmic reticulum, where they get properly folded into bio-active enzymes. The exquisitely-formed enzymes control cellular chemical reactions, and the cell functions normally. There is a continuing stimulus/response interaction turning on and turning off proper enzyme production. Specifically, that’s the “homeostasis” so often spoken of in reference to Anavex 2-73.
Back, now, to HDACs.
In the case of Rodin Therapeutics (as best I can determine), the company apparently has a chemical that can inhibit HDAC activity, apparently targeting the chromatin of specific Alzheimer’s genes. Prevent those genes from being transcribed, by inhibiting the HDACs that expose the Alzheimer’s genes, and although a person has Alzheimer’s genes, they can’t be transcribed. They remain obscured in the protective chromatin.
Sounds good, in theory, at least. Several problems might arise. First, would be the creation of a specific HDAC inhibitor, one that locks only specific Alzheimer’s genes. If it inadvertently locks up other genes in the enclosing chromatin, all sorts of adverse events would occur.
Getting this molecule inside neurons might be problematic. Cells wall themselves off from external chemistries, and should any extraneous chemical entities gain entrance, pierce the plasma membrane, a host of mechanisms bind to and actively excrete the intruders. This is a common cause of bacterial antibiotic resistance. The bugs expel the antibiotics before they kill the bacteria.
I can’t discount the Rodin Therapeutics technology. It might work. But it’s far more complex, with multiple molecular targeting complications. It will need a lot of work to demonstrate efficacy on both lab rodents and humans.
I’m not impelled to check the stock price of Rodin Therapeutics. I don’t see it as Anavex competition in any regard. Two very different Alzheimer’s therapies (neither of which attempt to remove waste proteins—the universally unsuccessful treatment modality).
In Most Cases, Toxoplasmosis Immunologically Suppressed
I'm not certain that the biochemical mechanisms of action of Anavex 2-73 could have any therapeutic suppression or elimination of Toxoplasma gondii cells residing in human brains or other organs.
This microbe is rather commonly and successfully suppressed by a functioning immune system. It becomes pathogenic during periods of immune system weakness.
Whether or not Anavex 2-73 can support and strengthen immune responses remains to be determined and demonstrated. I've seen no indications of such.
Anavex 2-73 the 21st-Century Aspirin?
Not an inconceivable proposition.
First, it's profoundly safe --- as much as aspirin (which can cause internal bleeding).
And it has the prospect of treating a number of central nervous system and other diseases when symptoms first appear, with (yet to be determined) lasting efficacies.
Aspirin was first marketed (before the FDA existed) merely as an analgesic, a pain killer. Worked well for headaches.
Then, was soon found to reduce fevers.
Today, aspirin is commonly "prescribed" to prevent strokes and cardiovascular incidents resulting from blood clotting. Aspirin, among other "benefits" is an anticoagulant.
Recently, clinicians have determined aspirin to help suppress colon cancer.
Aspirin started out as a synthetic analogue of willow bark, which aboriginals chewed for various ailments. Acetylsalicylic acid ("ASA"), the chemical name of aspirin, initially had one therapeutic target, pain. Today, it treats multiple symptoms and diseases.
And, it's cheap and over the counter.
In a decade (or sooner), might this happen with Anavex 2-73? I've already presented the implications of an over the counter form of Anavex 2-73 made available for the safe and effective treatment of insomnia.
(Now, no, don't anyone buy any AVXLs thinking the drug will be on checkout countertops next year, with billions of dollars of corporate revenues. I'm peering across the near horizon, a decade beyond --- just to watch. The science is supportive of my conjecture, but science, alone, does not decide pharmaceutical outcomes.)
Serum Half-life Probably Not The Activity Period
Ya Don't Say?
This Is A Contradiction
Understanding of Mechanism of Action Not Required
Anavex Rett Science Is Good
Thanks for posting this URL, for this most important paper.
Here’s the abstract. I’ve color-marked the important facts for those of us who hold an AVXL position.
BACKGROUND: The Sigma-1 receptor (s1R) is an intracellular chaperone protein located at the endoplasmic reticulum - mitochondria interface with important roles in inter-organelle communication and the cellular response to stress. ANAVEX 2-73 (AV2-73) is a s1R agonist that has previously demonstrated favorable safety, bioavailability, and tolerability in Phase 1/2 clinical trials. Data from the ongoing Phase 2a study in Alzheimer’s disease patients demonstrate signs of dose-dependent cognitive improvement.
Given the reported ability of the s1R to restore cellular functionality, neurodevelopmental disorders may respond to the activation of s1R in a disease-modifying manner. One such disorder is Rett syndrome and the MECP2 HET mouse is a well-characterized model with a behavioral profile that mimics many aspects of the clinical picture.
METHODS: Female MECP2 HET and wild type (WT) mice were used throughout (N=19-20 per treatment arm). Chronic daily dosing of AV2-73 (10 or 30 mg/kg/day PO) starting at 5.5 weeks of age was conducted throughout a 12-week period of testing. Behavioral paradigms measured different aspects of motor coordination, reflex reactivity, and species-specific behavior (clasping). In a separate study, 4 weeks of daily dosing starting at 6.5 months of age was followed by optokinetic analysis of relative visual acuity and changes in respiration by whole body plethysmography. Significance at p<0.05 was determined by ANOVA and post-hoc comparisons.
RESULTS / DISCUSSION: In the younger cohort of mice, chronic dosing with AV2-73 significantly improved performance of the MECP2 HETs in different motor and gait paradigms, and reduced clasping behavior to WT levels. Among the older cohort, relative visual acuity in AV2-73-treated HET mice was returned to WT levels at the slower rotating speed. A reduction in apnea counts (~35%) relative to WT levels was observed in HETs receiving AV2-73.
CONCLUSIONS: AV2-73 significantly improves an array of behavioral phenotypes in the Rett syndrome mouse model in a dose-related manner. Based on these data, Anavex Life Sciences will start a U.S. multicenter Phase 2 clinical trial of AV2-73 for the treatment of Rett syndrome with the support of Rettsyndrome.org.
Might the Australian Trial Walk-aways Be Cured?
Company Arranges Or Has Funding
Anavex Announcement, Three Upcoming Trials of Anavex 2-73
http://www.anavex.com/about-us/overview/
Yes, What Happens If It's First Down Under?
What might be the implications up here if per chance (or evidence) Australia simply and quickly approves Anavex 2-73 for Aussies with Alzheimer's?
Or, in any other country, too?
Appropriately, we are fixed on FDA approval for sale and use in the US. But the problems Anavex drugs successfully treat are global.
How might American media react, at first to an Australian approval? Probably, "Australians approve risky, unproven Alzheimer's drug."
Then, a few months later, when Alzheimer's people all over Australia report living normal lives. "FDA pressed to speed American approval of new Alzheimer's drug."
Maybe just in Mexico, where drugs can be purchased over the counter, without prescriptions?
Anavex for Psychiatric Conditions
Yes, there are some yet-obscure and incomplete indications that Anavex sigma-1 receptor agonists might yield beneficial treatments for psychiatric conditions, from various forms of depression to schizophrenia.
If any of these involve poorly-folded proteins (enzymes) controlling psychological processes, an Anavex involvement or solution is plausible. Anavex sigma-1 receptor agonists are known to facilitate proper protein folding in neurons where mitochondria and endoplasmic reticula have become disconnected. These mitochondrial malfunctions appear to be at the root of a host of human diseases. Presently, the company is targeting just three; Alzheimer’s disease, Parkinson’s disease, and the rare Rett syndrome.
Anavex 2-73 has a number of advantages over other psychotropic medications. First, it is administered orally, without injection.
But much better, and unlike the majority of existing psychotropics, it has virtually no side effects.
The developing story of Anavex treating the three diseases presently in the Anavex spotlight may eventually expand to a diversity of disease types, beyond the neurodegeneratives presently being addressed.
Anavex Life Sciences Corp is likely to be bigger, have more medical impact than presently anticipated. The company’s therapeutic technologies are unique and revolutionary. Nothing else like them in pharmacies today. Yet to be proven, of course.
We are watching closely.
Very Clearly Explained. Slight Dilution. With Company Benefits.
Thank you. You explained the matter very clearly; actually answered my question, precisely.
Wouldn't it be nice if all postings attended to topical questions and subject matter?
I'll return to my "biology expertise," such as it might be.
Fill Me In. Dilution?
My biology expertise offers no understanding of the Lincoln Park (?) AVXL shares sale. Help me understand this one point.
Will these share sales result in dilution, where the value of my few AVXLs are reduced slightly in value because more, greater then the listed 42.17 million outstanding shares, are being created and sold?
If such a sale happens, if it results in dilution, I'd wish it weren't required. Still, if the dilution is 5 million, with a resulting total of 47.17 million outstanding shares, we still have a relatively small number among which future dividends would be divided.
A lot of start-ups keep selling more and more shares, into the hundreds of millions outstanding (which is not an outstanding position to be in).
Hope we can keep things where they are right now; or, at least <50 million outstanding shares.
Thoughts?
Trademark Registration Not Required
Bottom of page 10, "Protecting Your Trademark, Basic Facts About Trademarks"
https://www.uspto.gov/sites/default/files/documents/BasicFacts.pdf
We Gotta Stop This!
That's a great name.
But because it was posted here, it can never be used. It belongs to the poster, not Anavex.
If you've got a really good new trade name for an Anavex drug, keep it to yourself. That way, it has a slim chance of actually getting used. No names posted here can ever be used.
Media Firms Will Provide a Market Name
Yes, after FDA approval, Anavex will most likely engage a professional media firm to work out a new market name of their being-sold drugs.
"Anavex 2-73 Plus" not likely to be the name.
The firm will pull in target populations (older people) and form focus groups. Names will be tossed around in the room. Cameras will record how these potential, future patients respond to how the names sound, how they are pronounced, along with reactions to held up images of proposed colorful graphics for each drug.
Commercial drugs have two names. A trade name, and an assigned generic name. The generic name is long, with lots syllables, seldom used, something like dorglecontramub.
The trade name starts with a capital letter, say, "Alzgone."
There are FDA rules that affect this (of which I don't know the details). As I recall, the assigned trade name cannot be overly specific in desired outcomes. "Alzgone" is probably prohibited.
"Euneurogen" might be acceptable. "Eu-" means good or proper, "neuro" means nerve or brain, "-gen" means maker or origin.
Will be fun to watch.
Molecules Named For Their Chemistry, Not Discoverer
The legal, scholastic, official name of the Anavex 2-73 molecule is tetrahydro-N,N-dimethyl-2,2-diphenyl-3-furanmethanamine hydrochloride.
The trade name is Anavex 2-73.
Unlike some diseases, chemicals are assigned names seldom derived from the names of their discoverers. The discoverer’s name resides only in science history books.
Dynamite isn’t called nobelium. Nobelium is an element, No, named for Alfred Nobel, the inventor of dynamite.
I know of no drug named for its discoverer. Ever heard of flemingium? Alexander Fleming discovered penicillin.
Aunt Millie Isn't Fooled
“Say, aren’t we glad we got Aunt Millie into this Alzheimer’s drug trial? What’s the name of that little pill she takes every day, Annavecks, I think.
Now remember, the doctors told us we aren’t allowed to tell anyone about how well Millie’s doing these days. So don’t mention to anyone that she’s now sleeping each night perfectly. She never gets up and wanders around. She’s eating by herself.
And, get this, she went right over to the bathroom and used the toilet all by herself. And, she flushed and washed her hands. Ain’t that something?
It’s just been three weeks, and it sure seems like she recognizes us. Did you see how she smiled when we walked in here?”
“Ok, you kids, what are you talking about? I think you’re saying things about me, aren’t you?”
“Well, Aunt Millie, we are. We were just saying that you look so much better, get around better, sleep better, and you seem to know who we are. A few weeks ago when we came here to the Lost Days Nursing Home to see you, you didn’t know who we were. You just sat there. What happened?”
“Well, let me tell ya. That little pill I have to take with breakfast is really fixin’ me. The doctor told me that it just might be a sugar pill. Neither he or any of the nurses know which pills are the good ones and which are the phonies.
But they can’t fool me. Right now, I can tell who every one of you are. I remember your names now.
Come on. Get that bottle of pills they keep hidden in that drawer over there and let’s get outta here. A got a bunch of stuff at home I want to do. I want to finish that painting I started, and call up Ava Mae and start talking to her again. She needs to hear from me. I just remembered her phone number, 321-555-4546. Get me my cell phone. I stored it in that blue bag back in the dressing room. I remember right where I put it.”
*****
Unreal? I don’t think so. Keeping conversations like this from being recounted after care givers and family members leave the nursing homes or care centers will be impossible.
The big Phase 3 double-blind Anavex 2-73 Alzheimer’s trial. Double-blind only on official forms. Reality reveals.
Check Number of Diseases Involving Sigma Receptors
Go to this site, the book linked in the previous posting:
https://link.springer.com/book/10.1007/978-3-319-50174-1
Then, if you have the time and urgency, click on and read the chapter abstracts and list out all of the diseases and conditions involving sigma receptors.
That would be a list, probably incomplete, of the diseases and conditions Anavex Life Sciences Corp may eventually treat.
As mentioned before, it'll be a lot more than just Alzheimer's, Parkinson's, and Rett.
Multiple System Atrophy (MSA)
Is similar in some physiological effects to Parkinson's.
Therefore, Anavex 2-73 might be helpful.
The same, continuing question: Just what and how many degenerative diseases might Anavex drugs treat or prevent?
I doubt it will turn out to be only Alzheimer's, Parkinson's, and Rett.
Factual disclosure: As it happens, I have a mild case of hereditary spastic paraplegia, where my long spinal nerves controlling the adductor muscles of my legs (and a few others) remain inordinately excited, keeping me from a normal gait. Have to use a walker. No pain, just the discomfort of inhibited ambulation.
A French researcher inserted the genes for my condition in some lab rats, and sure enough, their rear legs tightened up, as with me, from the hyperexcitability of the long motor neurons controlling leg muscles used for normal gait. After a week or so of drinking water infused with Anavex 2-73, the rats lost their spasticity and walked normally. I, therefore, have every reason to believe this will work for me, too (rat, or not, that I am). Anavex sigma-1 receptor agonists have great potential for the treatment of hereditary spastic paraplegia (HSP), and a related set of conditions, primary lateral sclerosis (PLS).
I therefore have a personal non-pecuniary hope for FDA approval. (I strive to not let that influence the validity of my postings here.)
Jimmy, Well Said. Nailed All the Approval Criteria.
That's it.
We'll be watching it happen next year. No competition.
Cognition Improvement Never Demonstrated Before, Nor Cognition Maintenance.
Ongoing Risk/Reward Analysis, Future Options
Yes, no one should (nor probably does) jeopardize normal family budget or retirement funds with a position in AVXl. Risky, il-advised. Risk only whatever purely discretionary funds one might have. Far greater odds than playing the lottery.
With Anavex, I’ve done that, taken my position with some funds I inherited. My family budget is not jeopardized. Presently, I have a small portfolio of AVXLs which are, on the basis of known facts and factors, likely to be nicely rewarding a few years.
But if the three up-coming Anavex 2-73 clinical trials fail, and Anavex Life Sciences Corp goes bust, my family finances will be essentially unchanged. If FDA approves the drug for any one of the three diseases, my family will have a few nice things in coming years.
I monitor my risks with Anavex each day. They have not grown at all. They are inverse to the share price.
But if and when that begins to ascend, I will even more closely monitor the events and information that might clearly have caused the share price ascent. With that, I’ve retained, or will have then available, a few funds with which to take an options position on Ananvex shares, payable at a future strike price, some many months or years away.
I know better than to ever take an AVXL position on margin (borrow funds to buy, hoping to be able to sell at a much higher price later).
Anavex IS a small pharmaceutical start-up. As has been pointed out by others (a few in particular), the success record of such companies is abysmal. Not something to plan one’s family finances or retirement on.
But many investment advisories state that when one is confidently positioned financially, with solid income sources, it is not unwise to designate a small fraction, no more than 5% of that (AFTER all other financial obligations have been covered, or known to be covered in the future) to be invested in yet-unproved speculations such as Anavex.
When doing so, invest wisely and carefully. There are thousands of equities we retail share holders can buy. Do the due... due diligence (“DD” for those who use only their thumbs). Educate yourself about whatever speculative stock you might consider. Make sure it’s not just a story, that although few or no revenues are coming to the company, the prospects for such are solid—as so clearly is the case here with Anavex.
And yes, I’ve posted some pretty monstrous forecasts of Anavex revenues and potential share prices. Those are unrelated to any of the above. My AVXL position has remained small. If any of those prognostications come true, I’ll be handsomely rewarded. On the basis of Anavex science and the global medical needs it will accommodate, my projections are not out of the question. Let’s watch how it all works out. Results from the 3-month Rett trial should be out at the very end of this year, or sometime first quarter next. With those data, the real Anavex story begins. Today, we are still looking at only short movie trailers, short scene clips of a series of Anavex films to play out, full length on computer screens across the world next year.
We have prime seats in the theater. I’ll be warming my popcorn. An occasional adult beverage will be enjoyed, too.
Best wishes to all who are following the Anavex story. It's a good one.
Anavex Better Than Senolytics? Anavex Antisenescent Drugs?
A new treatment approach to senility and aging is beginning to emerge, the use of “senolytics,” drugs that destroy (“-lytic”) senescent, old, non-functioning cells.
With these, it is hoped or presumed, senility and the related debilities of aging will be obviated, getting rid of old, non-functioning cells, leaving in place yet-functioning cells.
Here’s an article on the matter at the Mayo Clinic:
https://www.eurekalert.org/pub_releases/2017-09/mc-mcr_1083117.php
Should this technology mature and prove useful, all well and good.
I would suggest that Anavex Life Science Corp has in their pipeline molecules that might prove even better. Instead of destroying old, poorly- or non-functioning brain cells, Anavex molecules restore them to a more youthful function status. No loss of brain cells. No volumes of dead cell tissues and compounds to eliminate.
Might Anavex molecules prove to be “antisenescents,” drugs that keep nerve and brain (or other) cells from aging and dying?
Might anti-aging pharmacotherapies be in the Anavex armamentarium?
Anavex 2-73 is known to put back together dislodged or disconnected organelles in neurons, and the binding targets of the Anavex molecule that allow this, the sigma-1 receptors, are in the cells of most other body systems. Good reason to hypothesize Anavex sigma-1 receptor agonists might be able to restore normal, youthful functions, the homeostatic state, in a variety of cells and organs, not just nerve and brain cells.
Antisenenscence. The delay and suppression of cellular and organ system aging. Might Anavex Life Science Corp eventually lead the way?
Nope, Am Too Wordy
Insomnia Relief, Alone, Assures FDA Approval
Consider several well-established facts.
1. In the Australian trial, those Alzheimer’s patients suffering from insomnia no longer did while taking Anavex 2-73.
2. In that study, there were no reports of any participant on Anavex 2-73 that suffered from insomnia. All slept well.
3. Insomnia and nocturnal wandering are severe complications of Alzheimer’s disease.
4. Anavex 2-73 exhibited only low-level, infrequent side effects in the Australian clinical trial. Side effects are not a disqualifying factor.
With these, it is reasonable to presume FDA approval of Anavex 2-73 consequent to the up-coming double-blind Phase 3 Alzheimer’s clinical trial, should, per chance (well, exact cause), restoration of normal sleep patterns be the single, only symptom improvement.
Because the drug is safe (no side effects of consequence), is easily administered (orally, not by injection), and would prove universal restoration of normalized and thorough sleep patterns, the drug would gain FDA approval for that symptomatic improvement, alone.
Keeping Alzheimer’s patients from getting up and wandering around at Alzheimer’s care centers is a major, intractable problem. The disruption of normal sleep then causes consequent other problems.
Alzheimer’s care givers and treatment facilities would be delighted to be able to eliminate the insomnia problem. The use of the new drug would improve the standard of care for these patients.
Approval of a new drug must a) be safe, few or no side effects, and b) exceed the current “standard of care,” give better treatment results than currently available drugs.
None of the four Alzheimer’s treatment drugs are noted for effectively treating insomnia or nocturnal wandering. Other than conventional anti-insomniac drugs, each of which have severe and lasting side effects, Anavex 2-73 can stand alone and above, creating a new, better standard of care.
Let’s watch (and anticipate) the results of all three of the upcoming clinical trials. Will firm sleep be recorded in most or all participants? Very, very likely. The stochastics (chances) for this are high. What are the chances that all of the Australian participants only incidentally gained sleep benefits; that any larger population of Alzheimer’s patients might have a more normalized (Gaussian, bell-shaped-curve) distribution? The chances of all of the Australians gaining rather complete sleep profiles, by chance other than exact Anavex cause are extremely tiny. The numbers tell. ‘Twern’t just chance.
Ihub Readers Are Not Presumed Dummines
Readers of my Anavex postings can intelligently discern which are solid, fact-based presentations, compared to others that are so more clearly conjectural. Lastly, intelligent readers will take a chuckle with my way-out, just-for-fun speculations, such as a future Anavex No-ConCuss drink that both prevents brain concussion symptoms and increases test-taking cognition. Most of us, here, can have some fun, from time to time.
Same with my imaginary (or not) projections of future Anavex valuations. No one here is going out and taking big loans to take big Anavex positions, on the presumed assuredness of future share prices in the low thousands.
Get real, folks. The Anavex science is. Everything else is some form of speculation, much of it for fun (during these many months of dead time).
Things will get far more serious when new clinical results appear late this year or early next. The application and validity of Ihub postings will take on a new seriousness.
Perhaps a few posters think readers take their postings as seriously as they imply for mine. Not so, in either case.
Then, the Sequel
After Billy, the high school left guard, staggered off the field and drank the mandated bottle of Anavex No-ConCuss, he went back to school on Monday, and had a big (of all topics) biology test on Wednesday.
He had to answer the kinds of questions I used put on my high school biology tests. Many are cellular biology questions, where keeping track of the many chemical names (either acronyms or long words) and how they interact can be daunting. Mere memorization is but the first step in attaining a competent grade. Must also be able to know how the molecules react, in proper sequences, in their proper intracellular locations.
Billy studies hard for the test, takes it, and awaits its graded return in Friday. Lo and behold, he gets an A.
Only two other kids got that grade. We all recall just who those kids were, don't we? The big football player (we recall their types, too) never stood out academically. But, with this studied-for test, he excelled.
He had to answer for it. No, he had no answers scribbled on the back of a card up his sleeve. He just clearly remembered the stuff he studied. It made sense, and he was able to recall it, just like the smart kids.
The result? Billy and his friends discovered that he had done well on the test, after studying hard for it, because he was drinking daily a bottle of Anavex No-ConCuss fluid, prescribed to him by the football team physician to keep anything bad happening after his mild concussion in last Friday's football game.
But he started dividing half of the bottle of No-ConCuss with his friends, and their grades, too, went up.
This was noticed at other schools, too. In the end, lots of kids ended up gargling mouthfuls of Anavex No-ConCuss, especially in the weeks before taking their SAT tests. All their scores went up.
Fanciful? Surely. Out of the question? By no means. Let's see where Anavex molecules have applications beyond the current Central Nervous System diseases. If they can treat those, why not other neurological deficiencies or malfunctions?
It's all, is it not, "homoestasis," in neurons and the brain.
Interesting Conjecture: Anavex Concussion Treatment
So, could an Anavex molecule easily (orally administered, easily crossing the blood/brain barrier) rather immediately and effectively treat athletic and other concussions?
Inasmuch as these are almost entirely neurological injuries, where nerves and their neurons fail to function properly — where homeostasis is physically disrupted — and because Anavex sigma-1 receptor agonists restore neuron function, the question should be considered.
I wouldn’t be surprised if, behind some lab doors somewhere some post-doc is carefully concussing some lab mice or rats, then putting some milligrams of an Anavex sigma-1 receptor agonist in the rodents’ drinking water.
As with so many other new, innovative Anavex applications, ponder the significance of this. “Hey, kid, get off the field. Jones, get in there and take Billy’s left guard position.”
The high school kid staggers off the field after a hard blow to his head, but a small bottle of Anavex No-ConCuss drink is swallowed, and the kid stays out of the rest of the game.
On Monday, he’s feeling pretty normal, and resumes smashing guys (and getting smashed) at left guard.
No chronic, developing debilities from the kid’s football concussions, neither while in high school, nor in his college or NFL playing years. He remains cognitively adroit his entire years.
The Anavex product, “No-ConCuss” saves tackle football.
NFL, give Anavex a research grant on this.
I Sleep Well Each Night
Followers of this board recognize frequent, persisting posters, of which I’m one.
A number of us would be, by others, inaccurately characterized as “pumpers,” people who post imaginatively positive and glowing reports of future successes of the company we support (Anavex Life Science Corp).
In the middle, quiet infrequently now, are incidental posters merely asking good questions or expressing middle-of-the-road perspectives on the company and its future.
Then, a few others rather consistently post warnings about Anavex’s future, questioning its science, management, funding, or other factors they believe will obviate any future successes. For them, an investment in AVXL shares is either unwise, or plainly risky.
I’m reasonably competent in science. I’ve parsed the extensive peer-reviewed, published literature on the Anavex science, along with the company’s presentations on the subject. Personally, I’m convinced of the company’s great future. With discretionary funds, ones I can lose without affecting my family finances in any way, I’ve taken a small AVXL position. I think it will eventually be very rewarding.
I’m pleased to post my perceptions of Anavex science and the therapeutic and financial outcomes it will result in.
But the several Anavex naysayers here are frequent and consistent in their misgivings and warning about the company and it’s so-questionable molecules.
Those postings allow me to sleep well each night. I don’t want any un-knowing newbie to come here, see my postings alone, and turn right around and bet the ranch on an Anavex future.
Those who ponder and agree with my Anavex perspectives are advised to invest only discretionary funds in AVXL shares — if any at all. It’s a matter each reader will have to decide upon personally and responsibly, of course.
How, then, shall it be in a year or so? Will Anavex have gained FDA approval for the treatment of Rett syndrome, Alzheimer’s disease, and Parkinson’s, and thereby become a major profit-making and dividend-producing pharmaceutical? Or, as so strongly implied by the few Anavex skeptics who so consistently post here will all of us who have taken AVXL positions have lost our investments as Anavex Life Science Corp devolves into bankruptcy?
If it’s the former (I am convinced that it is), I’ll make no posted references to the skeptical postings that will have proven to be so inaccurate.
If it’s the latter, where I’ve lost my small investment and Anavex goes bust, I’ll be sordidly interested in whatever “told-you-so” postings that might appear, if any.
The main thing is this. Every perspective on Anavex is available here. Everyone must conduct his own, detailed due diligence. After spending some time reading the Anavex Ihub postings, no one should be making any ignorant, low-information investments in the company. Many perhaps, have decided to stay away from an AVXL purchase, not wishing to take on the perceived risks of such.
Therefore, I sleep confidently each evening. Investments in AVXL, or decisions against them, are, from this board, well-formed.
I wish for everyone the best personal outcomes with their Anavex decisions, whatever they might be. The information for such is readily available.
Cellular Homeostasis, Or Other Mechanisms, Too?
But those of us with considered AVXL positions retain a persisting grin...
...one we'll display on the way to the you know where in a few years.
Not Similar In Any Way
Bryostatin-1 (Neurotrope) is in no way similar or comparable to Anavex 2-73. Bryostatin (if it proved safe enough to use---it didn't) works at a downstream edge of the Alzheimer's disease process, working to stop or remove waste protein accumulations.
Uniquely, by entirely different mechanisms of action, Anavex 2-73 re-connects and restores normal mitochondrial/endoplasmic structure and function, thereby restoring normal neuron function. It works at the upstream edge of Alzheimer's, where the disease process begins.
Bryostatin exhibited disqualifying adverse events (side effects). Anavex 2-73 has never shown any of those, either in lab animals or humans.
A blemished apple/sweet orange comparison.
Be Careful With “Homeostasis.”
Understandably, the term “homeostasis” is appearing frequently in postings here.
Yes, Anavex 2-73 does restore a specific form of homeostasis inside aberrant, poorly functioning neurons.
But specifically, homeostasis is understood by practicing biologists to be, “...the property of a system within an orangism in which a variable, such as the concentration of a substance in solution, is actively regulated to remain very nearly constant.”
Homeostasis requires two things, presence of a variable, something that can change, and a mechanism that regulates, controls, or suppresses such changes.
Classic textbook case is thermal homeostasis, where the body attempts to maintain a core temperature around 37 degrees Celsius (98.6 degrees Fahrenheit). If temperature drops, one is chilled and prompted to put on some more clothes. Shivering heats muscles and tissues. If heated, some clothes come off, and the body sweats, promoting evaporative cooling on the skin. In an infection, the body hikes the homeostatic temperature, bringing on a fever, to reduce optimal microbial growth temperature. Most bacteria and viruses function best at 37 degrees C, are less functional at temps above that. Except when excessive, fevers are normal, healthful body mechanisms working against infectious agents. Thermal homeostasis is varied by the body.
It is not accurate to claim or imply that Anavex 2-73 restores any and all cellular homeostatic processes. There are so many, mostly unaffected by any sigma-1 receptor agonist, natural or synthetic.
There are a multitude of intracellular variables that must be keep relatively constant. Concentrations of ions, sugars, electrolytes, proteins, etc. are maintained. Of course, disease malfunctions occur when concentrations change beyond normality, when molecular or ionic homeostasis is not maintained.
So, how, then can we concisely and more accurately refer to the unique, therapeutic properties of Anavex 2-73, other than a generalized “homeostasis?”
The simplest, most accurate phrase might be, simply, it “restores neuron function.”
Few people have ever heard of, or use the term "homeostasis." "Normal function" is instantly understood by everyone.
Anavex 2-73, a profound new drug that restores neuron function. That covers it rather completely (at least until restoration or fixing of other disease modalities is demonstrated).
All of the Anavex target diseases involve, are caused by, neuron dysfunction. Our drug restores neuron function, simply. Nothing better could happen with these diseases.
I Retract Rett Trial Concerns. Murine Data Positive!
http://www.anavex.com/my_uploads/ANAVEX-2-73-as-a-Potential-Treatment-for-Rett-Syndrome.pdf
Fireman, thank you for bringing this Anavex presentation to my attention. I was negligent in not finding and studying it.
In short, it thoroughly affirms my earlier contention that the Anavex people must have had very positive treatment results with lab rodents for the treatment of Rett-like genetics and symptoms with Anavex 2-73.
In the Rett-like mice, as expected, the drug failed to provide complete relief from the many symptoms of the rodent Rett-like genetics. But relief was sufficient—if it occurs to the same degree in humans in the upcoming trial—that FDA approval appears absolutely certain.
The presentation, as it should, first noted the profound safety, lack of high-level adverse events, in the Australian human trial with Anavex 2-73. And no adverse events in the mice were noted or presented.
The positive outcomes are summarized on slide 30:
Yes, Seizure Control Alone Will Prompt FDA Approval
I'm no expert, by any means, on Rett syndrome. I've pondered the outcomes of a failure of the Rett syndrome trial (presuming, however, that the company knows from the start, from animal data, that it will be a big success).
I questioned the possibility that Anavex 2-73 might be able to fully restore or create normal nerve and body functions, as many of these not functioning in Rett syndrome don't appear to be open to sigma-1 receptor agonist treatment.
We all hope that's not so, that Anavex 2-73, by whatever means, might bring full health to the children with the disease.
But, I, too, think that if suppression or termination of epilepsy in Rett patients were all that the up-coming trial might demonstrate, FDA approval would be forthcoming. Safe suppression of this set of symptoms would be a marked quality of life improvement, worthy of Anavex 2-73 usage.