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Anti-aging may be the biggest Anavex story.
It is very, very likely that Anavex will treat glaucoma...and probably dozens of other diseases of aging.
One trick now, but in a year....
Conclusion, AVXL is not a ONE TRICK PONY...
New Anavex Clinical Studies.
Anavex webpage text:
[insert-text-here]
Current Job Openings
Director/Senior Director, Biostatistics
Senior/Exective [sic] Director, Clinical Development & Medical Evidence
Director/Senior Director/Executive Director, Clinical Development
I clicked on each of these to see what they might reveal. My impressions:
1. Director/Senior Director, Biostatistics
“This position will have full responsibility for the methodological and statistical considerations in the design, implementation and conduct of clinical studies as part of the development program team.”
Very clear; Anavex intends to implement and conduct new clinical studies. New Anavex clinical studies to happen; beyond those currently in operation. Someone with a PhD in biostatistics needed to properly quantify new clinical data.
2. Senior/Executive Director, Clinical Development and Medical Evidence
“This position will have full responsibility for contributing epidemiologic expertise in the planning, design, implementation and analysis of drug development projects and evidence generation across the clinical development span.”
Clear, again. New clinical programs by Anavex; beyond those presently in operation.
3. Director/Senior Director/Executive Director, Clinical Development
“This position will have full responsibility for planning, implementation and daily operation of drug development projects.”
This person will direct and oversee all of the above.
Big things being planned for. Existing managers not up to the new tasks; new executives are needed.
Think not? Click on the URL at the top and read the details of each of these positions. I’ve mentioned just an opening summary sentence. A multitude of details are listed on each page.
So, is CEO Christopher Missling passing his time twiddling his thumbs; or is he and his team planning to run new clinical trials with the Anavex molecules, for additional pathologies? If so, are these new trials wide shots in the dark, seeing if anything happens? Or, does Missling have a lot of proprietary information that supports greatly expanded clinical trials, for new diseases and conditions? Ever since Missling made his tangential remark about the “Anavex iceberg,” lo those many months and years ago, I’ve always presumed that Anavex has copious amounts of pre-clinical data that indicate both safety and efficacy for a diversity of diseases and conditions.
Now, it’ll all come into play. Continuing new announcements in coming months and years. Sigma-1 receptor biology, modulated and facilitated by Anavex’s proprietary molecules, yielding safe, new therapeutic outcomes will be front-page news in 2022 and 2023; building upon the positive outcomes of the Parkinson’s disease dementia, Rett syndrome, and Alzheimer’s studies. Plan for it. Anavex obviously is.
MOA desperation.
Understand you are making LAB HUMOR of course.
Ok, Brain Swelling?
“an increase in left hippocampus volume three months after the single treatment with Lomecel-B”
Not what the data show.
...would you generally agree that the US has a resurgence of COVID infections and deaths?
New Alzheimer's Vulnerability Tests
I am puzzled at how (without very accurate diagnoses and testing) they would prove that an Alzheimer’s patient has been prevented from getting Alzheimer’s?
A private bidding war, perhaps?
I repeat, possibly great Alzheimer’s TLD IS reading out this year! Like Dr. M mentioned too even if blarcasamine just stabilizes the disease it will be a huge success!
For me, too.
For me - AD results will be the main event - if Rett pediatric results also come - icing.
Ah, just as I thought.
Sig-1R activation a) enhances the autophagic flux in human cells and in Caenorhabditis elegans....
Thanks. Yes, this may require mouse studies.
Isn't the Sigma1 receptor a mammalian mechanism?
Once again, blarcamesine prophylaxis.
The use of blarcamesine as a CNS (or other) prophylactic, a drug that will prevent the onset of a disease before any symptoms ever appear, has been discussed. For a few, even mentioning the possibility of this is regarded as “pumping.” Should that be your perspective, read no further. The following is too much for you. Stay safe. Click off to the next posting.
Yes, clearly, if blarcamesine or any of the other Anavex sigma-1 receptor activators prove to provide prophylactic functions, their use to prevent, not just treat various CNS diseases will be massive. Dr. Missling himself tangentially alluded to this possibility. Dr. Randi Hagerman, a world-class CNS disease researcher stated that she’d like to take blarcamesine prophylactically.
The biological consideration must be this. If blarcamesine is proven (in the Phase 3 clinical trials) to stop or reverse the progression of Parkinson’s disease dementia, Parkinson’s disease, and/or Alzheimer’s disease, what could be the biological mechanism that would prevent the drug from stopping the progression of any of those diseases at their very earliest, pre-symptomatic stages?
If the drug can successfully treat those CNS diseases after they’ve developed and set in, with detectable symptoms, there is no biological or chemical reason those diseases would not also be stopped at their earliest stages, before symptoms ever appear. That would be prophylaxis; prevention.
A good number of postings have told of new methods to detect Alzheimer’s and other CNS disease vulnerabilities before those diseases ever appear. Presently, their only utility will be to allow people who are thereby destined to suffer to prepare for that suffering. Presently there are no really useful drugs for Parkinson’s or Alzheimer’s.
But, in a few years, after blarcamesine is approved to treat Parkinson’s and Alzheimer’s, how will those new CNS disease vulnerability tests be used? Will it be A, or B?
A. “Mrs. Smith, we’ve detected that you are destined to suffer and die from Alzheimer’s disease. But fortunately, there’s the new drug blarcamesine that can stop the disease’s progression after it sets in. We'll just watch and wait. When you start to get symptoms, we’ll get you on the drug right away.”
Or,
B. “Mrs. Smith, your test results came back. Sooner or later, you are destined to get Alzheimer’s. Therefore, let’s get you on blarcamesine right away, so you can continue to live normally. It will prevent the onset of even the mildest Alzheimer’s symptoms. Here’s your prescription.”
Fact is, sigma-1 activation by blarcamesine facilitates, modulates normalized homeostatic processes. With those, cells function normally, healthfully. Yet to be shown in human trials, but there is a strong probability that because of its facilitation of cellular homeostatic processes (there are many), blarcamesine (perhaps even better, Anavex 3-71) will prove to be useful anti-aging agents.
Presently, there is no evidence precluding such. Most significantly, the Anavex molecules are profoundly safe; do not produce side effects or adverse events of any endurance or consequence.
As I’ve claimed before, Missling has had someone, in house (proprietary info) conduct a variety of standard aging studies on organisms using blarcamesine. First would be to have Caenorhabditis elegans nematodes swim around and live and reproduce in water with blarcamesine, compared to the same C. elgans organisms in an adjacent tank without blarcamesine. C. elegans is one of the most commonly used and well-characterized organisms used in aging studies. Missling surely has data from them. Standard stuff; gained in short-term studies. Nematodes live and die fast, compared to vertebrates.
Other organisms are used in aging studies; I won’t list them out. But they all have neurons and cells with sigma-1 receptor proteins, which modulate homeostatic and other cellular processes.
Mechanistically, aging prophylaxis by blarcamesine is quite probable. Sooner or later, we’ll learn of preclinical studies.
None of the above has prompted my accumulation of Anavex shares. No need for that. Blarcamesine’s safety and efficacies for the targeted CNS diseases is sufficient. But those won’t be the end of the Anavex story. Lots yet still ahead.
After blarcamesine, even better: Anavex 3-71.
Dr. M said that they are planning a 3-71 trial for AD.
A set of them.
Is HSP a disease?
Really? How did I get my grant?
You're not a physician or biologist,
Right now, too expensive. But later....
why not self administer blarcasemine[sic] from a supplier like this one?
A Candidate New Disease
RedShoulder, thank you for that clear re-stating of Missling's comments. So very helpful. So much good stuff happening.
With personal interest and expertise, I noted noted this statement:
"We have other indications that we have not mentioned yet."
Of course, because of blarcamesine's optimization, activation of the sigma-1 receptor protein, which thereby enables the cell to restore or strengthen a diversity of homeostatic processes (all of which allow proper cell physiology) --- the MOA (mechanism of action, the drug will have applications for any number of diseases yet to be discovered. In a few years, Anavex and blarcamesine will be known for successfully treating not just a few CNS diseases but an ever-widening spectrum health conditions.
As in the past, I'll once again predict one new rare disease for blarcamesine; one that I have, in a mild, only slightly debilitating form: hereditary spastic paraplegia (HSP). There are several dozen genotypes of the disease, varying in severity. But in all cases, motor neurons, controlling muscles, lack sufficient levels of gamma-aminobutyric acid, GABA. With that deficiency muscle-controlling nerves become hyperexcited and fire continuously. The attached muscles are continually contracted; are spastic.
In a hard-drive failure I lost my copy of an obscure paper that showed HSP-model rats, rats with an inserted human HSP gene, were able to walk normally after drinking water than had Anavex 2-73 in it; in just a few days of such therapy. Blarcamesine was shown to optimize or increase GABA levels in girls with Rett syndrome.
Consequently, HSP may well be one of Missling's diseases "not mentioned yet." If it's not, it should on his ever-widening list. I'm eager to be a test subject in a clinical trial of blarcamesine for HSP. If I'm not stuck in the placebo arm, I'll be able to get rid of my walker and gait about with normal ease.
The existing Alzheimer's drug.
Those questions are nicely put. Slow, Stop, Reverse, Prevent. Yes, how far can A2-73 go, and with which patients does it go all the way!
But after 14 weeks...?
Yes, the four data plots show very significant score improvements for the 14 weeks of the trial. Those, alone, when confirmed in the Phase 3 study, will prompt FDA approval of blarcamesine for Parkinson's disease dementia.
But two related considerations. First, the trial ran for only 14 weeks. But the therapeutic dose (50mg) was not attained until it was titrated up to that level, starting in third week. Simply, the targeted 50mg dose level occurred only for the final 11 weeks. But even in that shorter period, the favorable therapeutic scores were dramatically increased.
However, secondly, what evidence is there that this 14/11-week dosing period is optimal? In the trailing weeks were the score increases tapering or leveling? Or, had the trial continued for another three months or more, would the scores have continued to improve?
Favorably changing neuron physiology takes time. In this trial, 14 weeks were allocated, with incontrovertible success. But in chronic dosings, over much longer periods, months, even years, there is the prospect that healing (sorry, had to use that term; it applies) might continue; all the way to normalcy.
Four questions for blarcamesine:
1. Can it slow the progression of various CNS diseases?
2. Can it stop the progression of various CNS diseases?
3. Can it reverse progression of various CNS diseases?
4. Can it prevent the onset of various CNS diseases?
In this study blarcamesine not only slowed or stopped the progression of Parkinson's disease dementia (PDD), it reversed it. People taking the drug got better.
It stands to reason, therefore, that were there an early, pre-symptomatic detector of PDD vulnerability, blarcamesine dosings could be prophylactic, preventing the onset of the disease altogether.
What, then, are the probabilities or possibilities of similar effects of blarcamesine in Alzheimer's disease? Will it be shown to not only slow or stop Alzheimer's progression, but, in fact, reverse it? Even better, will it actually prevent the disease?
Very likely, on all accounts. Let the trials begin.
No Cherries Today. Big Fat Data Apples.
cherry pick data and cherry pick release of that data..
Another Anavex Success. Safety and Efficacy Again.
I just zoomed in and perused today's PDF:
https://79bcf7a1-8b8e-483b-b7cf-f5c5192a6d63.usrfiles.com/ugd/79bcf7_ff6b864593fb4418ab306474dd535d35.pdf
Everything absolutely positive; exactly as I’ve expected and predicted. Once again, the unique, novel, proprietary Anavex science in the treatment of a severe CNS disease is proven safe and effective, in real humans with a real CNS disease. This time, not transgenic mice. Real people, with a real disease, with really positive therapeutic outcomes.
Notice that so far, not a single post from an Anavex naysayer telling how the study data and outcomes were flawed, inaccurate, or poor. Just the usuals with the usual: “Yea, but it took too long. The drug won’t get approved until five years from now, if ever.”
I sent the PDF off to my brother-in-law, who has Parkinson’s disease still in early stages. In a year or two, he’ll be able to stop, perhaps even reverse the progression of his Parkinson’s. His neurologist will be able to prescribe it. Or, even before, he may be able participate in the Phase 3 study. For him, and all with Parkinson’s, I’m delighted.
Actually, not a hard sell at all.
Prevention is a much harder sell to many people. It usually requires more effort.
Another Pathology for Anavex to Treat — Septic Shock
In this US patent application dated January 27, 2022 the word “Anavex” appears 63 times, in reference to the company’s several proprietary sigma-1 receptor agonist molecules. I found the two following statements most relevant to Anavex Life Sciences Corp.:
[0194] It is disclosed herein that S1R is a novel inhibitor of inflammation. In one aspect, methods of the presently disclosed subject matter are useful for preventing and treating septic shock.
And,
[0209] Useful compounds of the presently disclosed subject matter for regulating S1R include, but are not limited to, ANAVEX.RTM. 2-73, ANAVEX.RTM. 3-71, ANAVEX.RTM. 1-51, ANAVEX.RTM. 1079, ANAVEX.RTM. 1067, ANAVEX.RTM. 1037, ANAVEX.RTM. 1519, and ANAVEX.RTM. 1066.
Simply, the applicant claims that the sigma-1 receptor (SIR) inhibits inflammation, and that the listed Anavex molecules “regulate” the sigma-1 receptor.
The described pathology was the inflammation (shock) caused by sepsis, in this case in mice.
So, if eventually demonstrated in humans, at least one of the Anavex molecules will be an important treatment of sepsis in humans; a very life-threatening, difficult pathology to successfully treat. Conventional treatment is with antibiotics. But in cases of sepsis the pathogenic populations of bacteria are so high that antibiotics must be administered in very high dosages; which are problematic. Secondly, in many cases of sepsis the causative bacteria are antibiotic resistant. Being able to treat sepsis with any one of the Anavex molecules will be a major medical advancement.
After clinical trials in humans, another major Anavex therapeutic application. Effective activation of the sigma-1 receptor protein by the company’s proprietary molecules has another therapeutic application; new for the Anavex pipeline. Not just CNS diseases anymore.
Understanding of the entirety of sigma-1 receptor biology is yet incomplete. What next...? Might it involve any of the Anavex sigma-1 receptor agonists (activators)? So far....
The only thing that counts?
First to market in partnership with Acadia will be a huge upside. They’ll be first to market with a strong partner by at least a year or two.
For Missling, short-term gains, or long-term wealth?
Although diehard investors on this board put utter and complete trust in the present CEO and the science,....
Have nothing to contribute. Clinical data will prevail.
Falconer of all the people on this board I would think that you would take the opportunity to ask a question or comment to the FDA regarding A273.
An Anavex PR Success? Ha.
This post is an intended mockery of the many that say the AVXL share price is depressed because Dr. Missling fails to lead Anavex Life Sciences Corp like he should. The low share price is entirely his fault it is claimed. With a new CEO, perhaps one of our posters, the share price would quickly require three digits before the decimal.
Here's truth (Is in not?):
I see that the share price is up 9.49% today. Wow! Up almost an entire buck. Only thing that could account for this is the market's response to Missling's participation in the Annual Needham Virtual Neuroscience Forum, right?
Stock Indices and AVXL Share Price
As a retail investor (shareholder) in Anavex Life Sciences Corp., and as a biologist who can understand to a useful degree the unique molecular and cellular science of the Anavex molecules, I read here each day’s postings, looking for useful information.
From time to time, when I think I have useful information, I’ll put it up in a new posting.
But for now, in the first quarter of 2022, I haven’t seen many useful postings. Mostly, just whinings about dislikes with the personality and performance of the CEO, connecting the share price declines to him. For most of those, I can click on to a new posting after reading just the first sentence. Haven’t missed anything of importance.
Lots of posters trying to connect the moderating share price to the factors they present. But, so far this year, the AVXL share price is controlled mostly by the broad stock indices, the DJIA, and the NASDAQ. When they edge upward (as today), the AVXL share price follows (as presently the case). Vice versa.
As a biologist understanding the profound implications of Anavex science, once it becomes therapeutically available, I want “the market” (whomever that might be) to embrace Anavex and buy lots of AVXLs. Hasn’t happened. For me, a harsh reality. The market doesn’t think like I do.
Same for those who hope that the detailed listing of the AVXL share price “catalysts,” the several meetings and events in the future will push the share price markedly higher. But, nope, no matter how good the Anavex data are, those don’t much impact the AVXL share price at all.
Frankly, right now only one thing counts. If the stock indices ascend, so will the AVXL share price. Vice versa. I’ll continue to hold my moderate AVXL position (a few thousand shares) and just wait. Very clear. The share price will not launch until positive news articles about blarcamesine appear in the general press, in The New York Times, or the evening national news broadcasts, with titles similar to this: “In Big Study, New Drug Shows Safety and Efficacy Against CNS Disease.”
In the earliest, that will be in the last half of this year; but more likely sometime in 2023. Then, the postings on this board will be exciting, even informative. Will just have to wait. The postings with the most intrinsic fun will be those put up when AVXL first trades at $1249. Some of those will be "Told ya so's."
2023 yes. But interim fun points before.
CY 2023 [when falconer sees total Anavex success] seems like the back of the moon from here. I am rooting for positive findings on multiple clinical events between now and then which will serve to accelerate the passage of time.
Anavex Science Is Detailed — A Great Future
I just took an hour and scrutinized the new Anavex quarterly report. As a biologist I focused particularly on the presented science, pp. 25 through 29.
Exceptionally complete layouts of the discovered and clinically authenticated and demonstrated therapeutic applications and outcomes of the company's several novel, proprietary molecules.
The posting of comments on Anavex, or the taking or disposal of an AVXL stock position without carefully reading and comprehending the information in the quarterly report would seem unwise. Understanding the complexities of the unique science of the company's sigma-1 receptor agonists and how they can be useful therapeutic agents can be difficult. All of this is laid out in both the company's website, and in a more condensed (but yet detailed) form here in the quarterly report.
For me, once again, it was a reassuring read. 'Tis but a matter of time before the positive clinical results from the Parkinson's disease dementia study and the big Alzheimer's trial are released. With those data, blarcamesine will gain regulatory approval, in either the US (the FDA) or Australia (the TGA, Therapeutic Goods Administration). All of this should happen before 2023 ends.
Of course, as always, critical comments on any of the specific science points presented are warmly invited. Please, delineate any errors in what the company presented. If there are none, the company's future looks to be exceptionally bright.
Aduhelm not an unknown at Cleveland Clinic
One big unknown is how many AD patients would take one of these anti-amyloid drugs if they don't appear to work? Will doctor's prescribe them?
Cure? Who made that the success criterion?
Our experimental drugs do not cure AD.
But, for Anavex, when will it change?
No. Medicine is in constant change, and it's always advancing.
Because Medicine Rejects Change
Falconer, Can you say Why has it taken so long to get here????
Glaucoma Will Be Just One of Many
Sigma 1 Receptor Protein Protects Brain Cells Most Impacted by Glaucoma
First Wins?
...its all about “first to market”!
Mothers will move their daughters to blarcamesine.
They [Neuren/Acadia, with Trofinetide] will be first to market and enjoy first-mover advantages for a considerable period of time.
Will Happen...
Too much delay casts doubts.
UK Right and Left
The British do not know their right from the left.
Three-letter word change.
I remember paying $100,000 to a lobbyist to change one word in an omnibus spending bill. Well worth it.
WOW, what was that word?