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I just tried to find the study in PubMed, but accessing it was too complicated. But here is the URL for the study in the Indian medical journal. Just click this URL and the paper should come up as a PDF.
Thank you. I'm at peace with my Creator and have the salvation of His Son.
But my phrase "I'm Gonna Die" was actually sarcastic, in this regard --- relating to the safety and efficacy of the multitude of vitamins, minerals, and supplements I take. I'll briefly describe just one of my otherwise lethal ailments --- which has been utterly reversed by an unapproved supplement I take.
Seven years ago, from a severe urinary tract infection (actually caused by antibiotics I was prescribed, which selected drug-resistant bacteria) I nearly died from sepsis. In the ICU my kidneys were found to be in Stage 4 Chronic Kidney Disease. I was told I would have to have a transplant or start kidney dialysis promptly.
But I checked the world's literature on Stage 4 CKD and found a study by nephrologists in northern India that showed that the taking of 2ml of black seed oil, from the plant Nigella sativa, twice a day, in most cases, stopped and even reversed Stage 4 CKD. I bought some black seed oil and began to swallow 2ml each morning, and 2ml each evening.
In two weeks the nephrologist, arranging for dialysis, checked my most recent blood and urine tests. "They got the wrong samples. These can't be your data. You've got Stage 4 CKD. These are for someone with Stage 3 CKD."
The good doctor knew nothing of the Indian study (available in PubMed). I gave him a copy; he read just the abstract, and said, "Well, this looks pretty good. Keep taking this stuff and let's see what happens."
That was seven and a half years ago. I continue to have no indications of needing a transplant or dialysis. An utterly effective treatment of my otherwise lethal CKD.
Here's how it works. Black seed oil has a number of healthful chemical constituents, the most significant is thymoquinone. Among many other things thymoquinone chemically disables the Interleukin-6 cytokine, which in my CKD creates the inflammation that slowly destroys the kidney,
With this over the counter supplement, unapproved by the FDA, and unrecognized by American nephrologists (they need to talk to their Indian counterparts) my kidneys continue to function at a continuing ample baseline. There is no indication that it will fail. Most likely, in a good number of years, I'll die of some other cause.
With the review and approval of my oncologist and nephrologist (I have a latent cancer and Stage 3 (formerly Stage 4) Chronic Kidney Disease) I take a multitude of vitamins, minerals, and supplements --- for each of which I've discovered, read, and considered the findings of peer-reviewed journal articles listed and available at PubMed, for which each shows both safety and efficacy for my particular maladies.
But what about complex recipes for food dishes composed of obscure imported food components from who knows where? In modern life, ya takes ya's chances, right?
This, then, must also be true for the zillions of vitamins, minerals, and supplements sold over the counter.
Who can really know if complex (but tasty) recipes, with a multitude of obscure foreign spices, fungi (mushrooms), and "flavorings" in cooked combination are really safe? Stands to reason, the FDA needs to approve every recipe before its published or consumed. Both food chemicals and drug chemicals in the human body can cause all sorts of problems. FDA, we really need 'ya.
It’s an awkward, pejorative acronym used by various posters to mean for (but not by) AVXL longs, “We Got This.”
In fact, all of us who hold long AVXL positions know that neither we nor Anavex have ‘gotten this.’
But, for us, the acronym still works, when it’s “Well Get This."
The future of Anavex Life Sciences Corp is sound and strong. Will just take longer than we hoped.
In that regard, I’ve punched all of the relevant numbers into my AVXL investment spreadsheet. Over the years, with fully discretionary funds (left over after all financial obligations were paid off) I’ve accumulated a very modest AVXL position, a few thousand shares.
And, of course, the cumulative value of that position hasn’t much appreciated. But I knew going in that startup pharmas take many years (10 or more) to achieve full commercial success.
I can wait; when I compare what my AVXL purchase funds would have produced in a conventional ETF or other “safe” investment, compared to the rewards I’ll receive when Anavex finally has global sales for several CNS diseases. Then, I’ll be WAY ahead — worth the long wait.
What difference does it make? Don't you read what the experts post so authoritatively about Anavex right here in this go-to source for real information about Anavex?
Watch, Should Anavex ever get one of its drugs approved for sale and use anywhere in the world, this message board's team of Anavex experts will be telling, each day, how the approved drug doesn't actually work, causes severe side effects, and that there was some sort of skullduggery involved in the drug's approval. They wouldn't want their grandmother ever to take it, for any "approved" indication. They know.
Of course. Any publication or online posting claiming positive things about Anavex or their candidate drugs has simply "under-belly" proclamations of no validity or actual scientific validation. As the real Anavex experts here proclaim multiple times each day, Anavex is a bust, in every regard.
Postings here, telling of Anavex's deficiencies, are simply the pure and clear truth. We all need to lament that so many (including me) go elsewhere to find the real truths of Anavex. Anavex is going to go bust; every trial will be a failure (imagine, treating schizophrenia with a pill, of all things), and all of us who have taken and hold AVXL equity positions are going to lose every penny we spent, while envisioning eventual financial rewards from Anavex.
When the Anavex collapse occurs we AVXL position holders will so regretfully read the many "We told'ya!" postings. We are a pitiful bunch, watching the daily AVXL price variations, anticipating billions of dollars of eventual Anavex revenues. We can't be helped. From reading both murine and human trials results, and understanding to a sufficient degree the MOA (mechanisms of action) of Anavex's proprietary sigma-1 receptor agonists, we actually think Anavex is going to succeed. We read, believe the wrong stuff, so we are deluded by Anavex's apparent "science."
“Successful cognitive aging” refers to maintaining cognitive function and avoiding significant decline as one ages. Recent studies have highlighted several factors contributing to successful cognitive aging, such as physical activity, social engagement, mental stimulation and a healthy diet. As part of its research in developing therapeutics to treat neurodegenerative and neurodevelopmental disorders, Anavex Life Sciences focuses on better understanding cognitive aging, superagers and how disease pathologies relate to cognitive aging. Lifestyle plays a key role in this area. For example, research shows that regular exercise can enhance brain plasticity and delay cognitive decline. Social interactions and maintaining a strong social network are linked to better cognitive function and reduced risk of dementia. Additionally, engaging in mentally stimulating activities, such as reading or learning new skills, can bolster cognitive reserve.
These findings suggest that interventions promoting physical activity, social connections, and mental engagement may enhance cognitive aging. Experts believe that public health policies focusing on these areas could mitigate the societal impact of age-related cognitive disorders, potentially reducing healthcare costs and improving quality of life for older adults.
“Superagers” and Relevance to Studies
Superagers are described as people 80 and older who exhibit cognitive abilities comparable to those of much younger people. This concept emerged from studies aiming to understand why some elderly people maintain exceptional mental acuity. Superagers typically display higher levels of memory, attention and problem-solving skills than their peers, aligning more closely with middle-aged adults in cognitive performance.
Research suggests that superagers possess certain biological and lifestyle characteristics contributing to their cognitive resilience. Brain scans reveal that their brains — particularly the cerebral cortex — tend to have greater thickness and fewer signs of age-related deterioration. Superagers also tend to lead active lifestyles, both physically and socially, which is believed to play a crucial role in maintaining mental sharpness.
Understanding the factors that contribute to becoming a superager can provide valuable insights into promoting cognitive health and longevity in the broader population. Currently, The Albert Einstein College of Medicine is recruiting a group of superagers and their adult children in order to conduct a comprehensive study on this subject.
Disease Pathologies and Their Relationship to Cognitive Aging
Disease pathologies can significantly influence cognitive aging, impacting how the brain functions over time. Conditions such as Alzheimer’s disease, cerebrovascular disease and Parkinson’s disease are primary contributors to cognitive decline in older adults.
Alzheimer’s disease, characterized by amyloid plaques and neurofibrillary tangles, leads to significant memory loss and impairments in other cognitive functions like language and problem-solving. These pathological changes disrupt neuronal communication and eventually cause neuron death.
Anavex is a clinical-stage biopharmaceutical company that is currently developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system disorders. As such, the company’s research encompasses the study of successful cognitive aging, superagers and how disease pathologies relate to cognitive aging.
Cerebrovascular disease, which includes strokes and other vascular problems, affects cognitive aging by reducing blood flow to the brain. This deprivation can result in both acute and chronic cognitive impairments, ranging from sudden, severe deficits following a stroke to gradual declines associated with chronic small vessel disease. Vascular contributions to cognitive impairment and dementia highlight the critical role of vascular health in maintaining cognitive functions.
Parkinson’s disease, marked by the degeneration of dopamine-producing neurons, primarily affects motor functions but also has substantial cognitive repercussions. Patients often experience executive dysfunction, slowed thinking, and memory issues as the disease progresses.
In addition to these specific diseases, comorbidities such as diabetes, hypertension and chronic inflammation exacerbate cognitive aging. These conditions contribute to neuroinflammation, oxidative stress, and metabolic dysregulation, further accelerating cognitive decline.
Understanding the interplay between disease pathologies and cognitive aging is essential for companies like Anavex in developing interventions to maintain cognitive health in older adults.
Advancements in Research Relating to Diseases Impacting Cognitive Aging
Research on disease pathologies impacting cognitive aging, especially Alzheimer’s disease and Parkinson’s disease, have made significant strides in recent years, and Anavex remains at the forefront of these advancements. These neurodegenerative disorders, which primarily affect older adults, are characterized by progressive cognitive decline and motor dysfunction, respectively. Understanding their underlying mechanisms is crucial for developing effective treatments and preventive strategies.
In Alzheimer’s disease, significant advancements have been made in elucidating the roles of amyloid beta plaques and tau tangles. These protein accumulations disrupt neural communication and lead to cell death. Recent research has focused on targeting these proteins to slow or halt disease progression. For instance, immunotherapies that clear amyloid beta plaques have shown promise in clinical trials, with drugs like aducanumab receiving conditional approval. Moreover, tau-targeting therapies, including small molecules and antibodies, are being actively explored.
Anavex’s recent Phase 2b/3 Trial of Anavex 2-73 (blarcamesine) in patients with Alzheimer’s disease showed a high level of clinical efficacy and slowed neurodegeneration.
Genetic research has also shed light on Alzheimer’s pathology. The identification of risk genes such as APOE4 has improved understanding of genetic predispositions and led to personalized medicine approaches. Additionally, advances in biomarker development, such as cerebrospinal fluid analysis and PET imaging, enable early detection and more accurate diagnosis, crucial for timely intervention.
In Parkinson’s disease, research has focused on the role of alpha-synuclein aggregates, which form Lewy bodies, disrupting normal neuronal function. Therapies aimed at reducing alpha-synuclein aggregation are in development, with several compounds currently in clinical trials. Deep brain stimulation, a surgical intervention, has shown effectiveness in alleviating motor symptoms, and advancements in DBS technology have improved patient outcomes.
The gut-brain axis has also emerged as a critical area of research in Parkinson’s disease. Studies suggest that gut microbiota may influence neuroinflammation and disease progression, leading to potential probiotic or dietary interventions.
An earlier study conducted by Anavex reported that blarcamesine significantly improved cognitive function, memory and REM sleep in patients with Parkinson’s disease dementia. This included improvements in complex cognitive tasks that impact quality of life — such as making a choice between similar objects and remembering daily personal experiences — which are often impaired in Parkinson’s disease.
Advancements in genetic, molecular, and imaging technologies have significantly enhanced the understanding of Alzheimer’s and Parkinson’s disease pathologies. These developments hold promise for more effective treatments and preventive strategies, ultimately aiming to improve the quality of life for individuals affected by these debilitating disorders.
Novel Investigational Therapies, Techniques, and Anavex in the News
Recent advancements in novel investigational therapies and techniques for cognitive aging are garnering significant attention in the medical field. One such promising area is the development of targeted therapies aimed at amyloid beta plaques and tau tangles, hallmark pathologies of Alzheimer’s disease. Researchers are investigating monoclonal antibodies like aducanumab, which aim to reduce amyloid beta plaques in the brain, potentially slowing cognitive decline.
Another innovative approach involves gene therapy. Scientists are exploring the use of CRISPR-Cas9 technology to correct genetic mutations linked to neurodegenerative diseases, addressing the root cause of cognitive impairments. Additionally, researchers are studying neurotrophic factors, which support growth and survival of neurons, for their potential to rejuvenate aging brain cells.
Advancements in neuroimaging techniques, such as functional MRI and PET scans, enhance understanding of brain aging by providing detailed insights into brain activity and pathology progression. These imaging techniques are crucial for early diagnosis and monitoring the effectiveness of new treatments.
Lifestyle interventions, including dietary modifications and physical exercise, are being integrated with pharmacological treatments to create comprehensive therapeutic strategies. Studies suggest these combined approaches may offer synergistic benefits, potentially improving outcomes for individuals with cognitive decline.
These cutting-edge therapies and techniques hold promise for significantly altering the landscape of cognitive aging, offering hope for improved management and treatment of related diseases. Anavex’s Phase 2 studies with Anavex 2-73 in Alzheimer’s and Parkinson’s patients showed progress in slowing cognitive decline.
Another investigational gene therapy, AB-1005, is being considered for Parkinson’s disease, while verapamil has been used to ease symptoms in a mouse model of myotonic dystrophy type 1. Studies are also exploring the use of macrophages tagged with gadolinium-loaded anisotropic micropatches to identify animals exposed to traumatic brain injury.
The COVID-19 Effect and Neuropsychiatric Pathologies
Current research by Anavex into the neuropsychiatric symptoms following acute COVID-19 infection, particularly in older adults, is revealing significant insights into the pandemic’s long-term impact on mental health. Studies indicate that older adults recovering from COVID-19 often experience a range of neuropsychiatric symptoms, including anxiety, depression, cognitive impairment, and psychosis. These symptoms can persist for months after the acute phase of the infection, a condition often referred to as “long COVID.”
Recent findings suggest that these symptoms may be due to several factors, including direct viral invasion of the central nervous system, inflammatory responses, and the psychological stress associated with severe illness and isolation. Neuroimaging studies have shown structural and functional changes in the brains of affected individuals, including alterations in gray matter volume and white matter integrity. Additionally, biomarkers of inflammation and neuronal injury are being investigated to understand their role in the persistence of these symptoms.
Particularly concerning in older adults is the potential exacerbation of preexisting cognitive decline and the increased risk of developing dementia. Ongoing research aims to identify specific risk factors, mechanisms, and potential therapeutic interventions to mitigate these long-term effects. Understanding these neuropsychiatric sequelae is crucial for developing targeted treatments and providing comprehensive care for older adults recovering from COVID-19.
The Importance of Research Into Successful Cognitive Aging
The investigation into successful cognitive aging by Anavex and other researchers represents an exhilarating field of study. This research holds the promise of fundamentally transforming the current understanding of the aging process and the various cognitive disorders that can accompany it. As scientists delve deeper into the mechanisms that support cognitive health in older adults, there is hope that their findings will lead to development of more effective therapies and interventions. These advancements could significantly enhance the quality of life for individuals experiencing cognitive impairments and neurological disorders, offering new ways to maintain mental acuity and overall brain health.
One particularly intriguing aspect of this research is the potential to identify and study superagers. By understanding the factors that contribute to their cognitive resilience, researchers can uncover valuable insights into the biological, environmental, and lifestyle influences that promote cognitive health in the aging population. This knowledge could inform strategies to help others achieve similar levels of cognitive preservation, potentially delaying or even preventing the onset of cognitive decline and related conditions such as Alzheimer’s disease and other dementias.
The study of successful cognitive aging not only aims to improve individual outcomes, but also address broader public health challenges associated with an aging society. Through continuous research and discovery, researchers appear to be on the brink of breakthroughs that could revolutionize how we approach aging and cognitive wellness, leading to a future where advanced age does not necessarily equate to cognitive
But utterly false. Directly opposite to what the experts who post on this message board tell every day here. Anavex is a poorly managed company who will never get any of their so-questionable drugs approved for anything. Those of us who hold AVXL positions are doomed to investment failure.
Pretty clear, the writers for Medical Device News Magazine haven't checked with the experts on this topic; the ones who post daily on this message board. They KNOW.
Alone, Anavex schizophrenia drug(s), can make the company.
As I've noted, the market for an effective schizophrenia therapy is gigantic. We are all eager to learn the results of any Anavex clinical trial of their drugs for the disease. Several factors can be surmised or considered at the start.
First, Anavex's sigma-receptor agonists (activators) are extremely well-tolerated; have no severe or disqualifying adverse event frequencies (bad side effects). This is both rare and highly desired for drugs acting in the central nervous system; in this case in the biochemistry of the brain.
Then, small doses should be effective, especially with Anavex 3-71. And, these drugs are administered per os, merely by swallowing the pill. No injections or infusions.
Lastly, manufacture of the Anavex sigma-1 receptor agonist drugs will be inexpensive. They are small molecules with convenient, conventional synthesis by proprietary processes. Profit margins will be large, while patient (health insurance company) costs will be moderate. Given the great costs of dealing with schizophrenia patients, both governmental and private health insurance programs will welcome the Anavex approach. Game changing.
Let's watch to see what turns up in the schizophrenia trial(s). If a clinical success, Anavex treatment of schizophrenia, globally, will, alone, make the company a major pharmaceutical.
What if prescription drug advertising were illegal in the US, as it is several other countries?
Check to see. Watch. Who are the major advertisers for the three major TV networks' evening news shows? If there were a drug no-advertising law in the US who would pay for, sponsor network TV news shows? Might medical news writers for the major TV networks have some understanding of where most of the dollars they get paid come from --- and write medical news reports accordingly?
The fool, here, who responds to another fool’s post is the greater fool. Foolishness is sufficiently revealed by its author, not its critic.’Nuff is enough.
No, you don’t read or recollect well. (As illustrated: I’m not “Falconeer.” Not “neerly” close. “Falconer,” please.)
Fact is, the sigma-1 receptor protein and its homeostasis physiology are conserved, exist in all mammals. Consequently, the effects of a candidate sigma-1 receptor agonist (activator) drug observed and quantified in a murine lab test animal, particularly in transgenic murines, those with inserted human disease genes, are useful to direct further human trials of the drug.
If the drug has no favorable effects in a transgenic murine (lab rat or mouse), its chances of producing favorable therapeutic results in humans with the disease are reduced. Clinical trials in humans are expensive. If the candidate drug can produce no favorable outcomes in transgenic murines, without further evidence of efficacy human trials may be cancelled.
Of course, neither the FDA nor the EMA approves a new drug solely on favorable, stat-sig transgenic murine trials. The drug must be proven in statistically-valid clinical trials in humans with the targeted disease.
Murine drug trials merely guide the early, preclinical drug testing directions. To imply, as you claimed I have, that murine trials assure “human efficacy” is false. Not so. Human trials are always required. Even non-biology teachers should know this.
It appears that sigma-1 receptor protein activation by an Anavex drug would ameliorate nephrolithiasis, the health problem of kidney stones. Big heath problem, gigantic market.
Then, Anavex Captures the Global Schizophrenia Market
Neither of us, in our postings today, accurately told what will be the full Anavex story. Not just blarcamesine for Alzheimer’s. A gigantic market need that Anavex will fulfill.
But what if Anavex’s schizophrenia trial turns up positive — as I believe it will?
Giant global market for a safe, inexpensive drug that is proven to successfully treat schizophrenia symptoms. Once the Anavex drug is discovered to treat schizo, as with blarcamesine against Alzheimer’s, there will be overwhelming economic forces to make the Anavex drug the SOC (standard of care), preferred drug for this severe disease.
With both of these diseases being treated globally by Anavex, widen the columns on the spreadsheets used to calculate eventual Anavex revenues.
No, many billions of dollars will be saved; annually and perpetually into the future.
Presently, controlling parties (government and insurance company officials) know little or nothing of Anavex. They have in mind, legitimately so weakly, just the two new monoclonal antibody (“MAB”) drugs approved to treat Alzheimer’s. They are very expensive (don’t reduce governments or health insurance companies health care costs), and are only slightly effective, for moderate treatment periods; with alarming and frequent adverse events (side effects).
But how will all of this change when the peer-reviewed Anavex (blarcamesine) paper appears in a recognized medical journal? Will health care skateholding officials, in both governments and health insurance companies, have the capabilities to plug into a spreadsheet the validated, published blarcamesine efficacy and safety metrics? Think that they will be able (or desire) to discount those big numbers?
With the publication of the peer-reviewed paper showing that blarcamesine does, indeed, successfully treat Alzheimer’s, at minimal cost, with ease of administration (orally, no MRIs or hospitalizations for treatment), with minimal side effects that can be obviated by timely dosing (at night), even the New York Times will post an article on the paper. An NYT article title such as this, “New Drug Holds Great Promise as Successful Alzheimer’s Treatment,” will open important eyes around the world. There will be social, economic, even medical pressures to bring blarcamesine to market. Ultimately, global economic forces will prevail.
Credible stuff. MABs of any sort won't be the Alzheimer's treatment future. (We know which molecules will be the eventual standard of care drugs for Alzheimer's and a few other CNS diseases --- the proprietary sigma-1 receptor agonists (activators) of a particular, yet obscure company.)
No, the very favorable, safe, effective clinical data about blarcamesine for Alzheimer’s remains obscured in the vast technical fog of clinical trial results. Few are paying any real attention, or simply can’t comprehend blarcamesine’s clinical results.
This matter, the things that will profoundly change the AVXL share price, won’t effectively change until the Real People, the elites who Know and Reveal, come right out and proclaim, “New Drug Effectively, Safely Treats Alzheimer’s.”
Of course, those People Who Know aren’t scientists. They are the editors and writers at the New York Times. When the NYT posts an article with the title above, Anavex’s future will be clear to everyone. But, not until.
Ok, for owners of AVXL shares, what might the $15.4 billion annual Anavex revenues mean? For yourself, determine, conservatively, how much of these revenues would go out as stock dividends each year.
I’ll presume, conservatively, by the time Anavex distributes annual dividends there will be (convenient for calculation) 100 million AVXL shares, 100,000,000. Presently, Anavex has about 82 million outstanding shares in circulation.
In a few years, what percentage of the anticipated $15.4 billion annual revenues ($15,400,000,000) will be dropped down to go out as dividends, for the then 100,000,000 dividend-gaining shares in circulation?
Check (or choose) the metrics.
If only 1% of the $15,400,000,000 of revenues goes out as dividends, that’s a total of $154,000,000; which would be $1.54 per share.
If it’s a 5% figure, dividends would total $770,000,000; a rate of $7.70 per share.
If 10% of annual revenues are dropped down to go out as dividends, it would be a dividend total of $1,540,000,000, a per-share rate of $15.40.
Later, I expect Anavex will gain approvals to treat a number of other CNS diseases with their unique sigma-1 receptor activators. Parkinson’s, schizophrenia, and the others listed in the Anavex pipeline. Considerable annual revenues from each of these; especially when considering global, not just US or European drug markets.
Over the years, with purely discretionary funds (funds that can be lost without harm) I’ve accumulated an AVXL position of several thousand shares. The metrics of any of my scenarios will be rewarding. In my estate’s legal documents it is noted that I intend to never sell an AVXL share. I’ll receive whatever dividends Anavex distributes, but at my death the ownership of my AVXLs will pass to the listed beneficiaries of my estate; primarily to my wife and children.
All of this is, by definition, long-term investing. Day-trading stock price speculators so frequently post their Anavex comments here. Fun to read — but they don’t apply to me (and many or most readers of this message board).
In five years, I’ll check back in with a report, to see if what I’ve envisioned actually occurred. Accumulating data and reports are all pointing in positive directions. I’m sleeping well (even without taking any blarcamesine). I’m patient.
I’ve restrained my postings in recent months (regarding blarcamesine, Anavex, etc.). Those familiar with my postings know that I have a rather complete understanding of the cellular physiology of the mechanisms of actions (MOAs) of the Anavex sigma-1 receptor activators. So very different from and so far more effective than the MAB (monoclonal antibody) competitors; and are more easily administered (orally), without AEs, adverse events; side effects. No brain hemorrhaging, no brain shrinkage. And more.
In anticipation of this presentation, a week ago I expanded my AVXL position. Had some discretionary dollars; which with my now slightly larger AVXL position have appreciated nicely — a share price gain that I contend will continue in the following weeks and months. Then, application for blarcamesine approval in the EMA. With that, future AVXL price appreciations will no longer be speculation. Schizophrenia approval will follow; will be BIG.
All of the usual AVXL naysayers are working hard at their keyboards to post reasons why, once again, as always before, Anavex will fail. I’m not going to waste my time trying negate their quasi-scientific Anavex naysayings. The “market” will prevail. Will be interested to see what the real investment experts, at the New York Times, for example, will be saying. Will general news media have stories to the effect, “New Drug Candidate Gives Real Hope for Alzheimer’s?” Should they appear, how will the public react to such news articles?
We’ll all be watching. When there’s some science I can usefully comment on, I’ll post it. Until then, I and my few AVXL friends will privately share our understandings. Things Anavex coming together just as expected.
Yes, once blarcamesine is approved and being used in the treatment of CNS patients, a major concern will always be the "side effects" problems with CNS (and other) drugs.
I contend that blarcamesine will have no "side effects" of any consequence or significance. For blarcamesine, it will be just the opposite. The drug will display favorable "side benefits." Not only will the disease being treated be favorably addressed (the drug will work), but, at the same time, a number of "side benefits" will be obvious. One side benefit of blarcamesine will be dramatically improved sleep.
This new Annovis drug may work, may provide certain therapies for Parkinson's, maybe even Alzheimer's. But I don't see it as competitor with blarcamesine or 2-73. Don't see that the Annovis drug will have any prophylactic function.
Eventual Off-label Anavex Prescriptions for Anti-aging Prophylaxis
Actually, it might be merely a defacto trial for this outcome when blarcamesine is approved to treat/prevent either Alzheimer's, Parkinson's disease, or schizophrenia. Very likely it will be discovered that people taking the Anavex drug gain favorable therapeutic outcomes not just for the targeted diseases, but concomitantly they exhibit reduced indications of physiological aging; such as having reduced brain volume losses compared to populations not taking an Anavex drug.
Hence, the eventual possibility of off-label prescriptions to use Anavex drugs as generalized anti-aging therapies.
The prospect of blarcamesine as an effective, safe, inexpensive generalized anti-aging prophylactic should be considered, even clinically tested. I'm certain that Anavex already has data on this from murine and other animal tests. When appropriate, the drug will be tested in a human trial.
Blarcamesine (or 3-71) as a generalized CNS disease and anti-aging prophylactic, where everyone at the at age, say, of 50, starts popping an Anavex pill each day, will be transformative in a multitude of ways. So significant as we Baby Boomers, and others, start to age out.
External Drug Manufacturers Conduct No Anavex Trials
All of that will involve deep legal matters and arrangements between an external manufacturer of Anavex's drugs and Anavex Life Sciences Corp.
Of course, none of those arrangements or contracts have yet been made. Anavex will have smart commercial lawyers cut the deals with external manufacturers, which will mutually benefit both parties. The manufacturer will make money by offering Anavex a good, competitive price for the pills it makes and packages. Anavex will make lots of money by selling the drugs.
I don't see that there will be any "non-AVXL uses." Anavex will be the legally recognized owner of the technology, which is validated by the company's eventual receipt of drug sales and use authorizations from drug regulatory agencies across the globe. No drug manufacturer is running clinical trials to gain sales approval of any Anavex drug the company might wish to sell.
AVXL had its low of the day just after the market opened today, at $3.78. But, so distressingly, it didn’t appear that many buyers or sellers of the equity read or paid any attention to the smart people who posted all day here (and days and months previously) telling that Anavex is and will be a loser as a no-revenues, no products biotech start up.
So inexplicably, after the day-long straight line ascent AVXL closed at near the high of the day at $4.29. What was the all-knowing market thinking? A 12.3% share price gain for the day.
Read the company's website. They are a major European drug manufacturer. Their making of blarcamesine, with their new, patented processes fits perfectly with Anavex's desire to gain approval to sell the drug in Europe for Alzheimer's.
The patent was granted to an Hungarian firm, which uses and acknowledges Anavex’s ownership, intellectual property rights to all forms of blarcamesine.
In all honesty, when I first saw that blarcamesine ADL p-value, as discrepant as it was compared to the other three, I thought that it probably disqualified the drug from ever being approved by the FDA. The other three p-values were way below the required p=0.05 threshold of statistical significance and therapeutic validity. But blarcamesine utterly failed the ADL test. The numbers don't lie.
When I first saw it I tried to figure out what this "ADL" phenomenon was. Researchers, for convenience, like to use acronyms. A lot easier to state throughout a report "ADL" instead of "activities of daily living." But retail stock equity investors don't know the language or acronyms of CNS disease research. So, I looked up the acronym.
"Activities of daily living." Being able to dress oneself, to eat, attend to personal cleanliness, etc. are all extremely important. Failure to properly attend to ADLs makes one an invalid.
But read the descriptions of Alzheimer's symptoms. ADLs are mentioned far down the list. Essentially, Alzheimer's diminishes cognition, the ability to think and speak, the things the three successful metrics of the blarcamesine trial excelled at.
So, blarcamesine will not be intended to target or treat patients with advanced stages of Alzheimer's, where the activities of daily living (ADLs) are already diminished and compromised. Just the opposite. With the number of new tests for early-stage Alzheimer's, even before any real symptoms can be perceived (the prodromal test factor --- detection before symptoms even begin to be perceived) the Anavex drug will have its greatest impact on the global Alzheimer's disease problem.
I anticipate, soon enough, that late middle age or early elderly patients will commonly be administered prodromal ("before symptoms") Alzheimer's tests. "Mrs. Smith, we have some bad news. Your test results came back and they show that you are going to come down with Alzheimer's disease. But, so fortunately, we now have a drug, blarcamesine, that will prevent the disease from progressing. Here is your prescription for the drug. It will allow you to be free of Alzheimer's symptoms in the years going forward."
How will the Alzheimer's Association and its members respond when they learn of these, blarcamesine's real clinical trial results?
Blarcamesine Didn’t Fix Patients’ ADLs. Does It Matter?
Yes, the trial results from blarcamesine being tested in early-stage Alzheimer’s disease showed significant statistical significance for three of the four matters being assessed. Meaning, that for those three Alzheimer’s problems the drug provided significant therapeutic outcomes. For them, the drug works, safely.
But blarcamesine didn’t achieve, even closely, statistical significance on the “ADL” test. It had a reading of p=0.234. To be statistically significant, meaning that the result was authentically therapeutic, not some random-chance result, the p-value had to be p=0.05 or less. The blarcamesine against early-stage Alzheimer’s ADL factor failed miserably; way too high, nowhere near 0.5 or less.
Should this matter? Does blarcamesine’s ADL treatment failure indicate that the drug should not be approved as a treatment for early-stage Alzheimer’s? It’s important to consider what, in medical practice and research, “ADL” is: “activities of daily living.”
I have extensive personal experience with the problem. Over about 10 years my father suffered and finally died of medically-diagnosed Alzheimer’s disease.
For the first 6 or 7 years he had virtually no “ADLs.” As it happened, my mother was an experienced registered nurse in a recognized neurodegenerative and brain-injury clinic. She knew the symptoms, course, and sequellae of Alzheimer’s patients. She was a medical professional who cared for such patients. She knew what Dad had, and how it would end up.
Simply, as is the case with virtually all early-stage Alzheimer’s patients, the recognized “activities of daily living” of my father were essentially unhindered. Cognitively, he very slowly became compromised; having to give up and sell off his accountancy practice. But he didn’t suffer from diminished daily activities until much later, when he had to be institutionalized.
What might have happened if Dad could have been treated with blarcamesine at the very earliest point, when medical testing of cognition showed what he had; and what was to come?
As others have mentioned, testing for drug efficacy against ADLs in early-stage Alzheimer’s patients yields no useful information. Simply, activities of daily living aren’t compromised at the start of Alzheimer’s — at the stage where blarcamesine will be therapeutically most effective.
In a recent posting I expressed my opinion that Anavex quietly had a lot important things happening and very positive developments should soon begin to be announced. The first of those just appeared, at the URL in the previous message.
On Sunday, July 28, 2024, that paper will be presented at the Alzheimer's Association International Conference in Philadelphia. This will validate both blarcamesine’s safety and efficacy in Alzheimer’s patients with early-stage Alzheimer’s disease.
The ability of blarcamesine to successfully treat four recognized Alzheimer’s disease severity metrics were assessed. The paper made this claim:
All but the ADCS-ADL scores were statistically significant; not a result of chance. Those with expertise on each of these metrics are invited to state their significance in this trial.
There have been posted concerns that only a few minutes will be devoted or allowed for the presentation of this paper, which will diminish or hinder a proper understanding of the paper’s findings. But, when this Alzheimer’s conference ends the paper does not evaporate. There will be ample opportunity for Anavex to subsequently answer questions and present further data or comments on the topic.
Then, of particular interest and significance will be the publishing of the long-awaited peer-reviewed medical journal paper on this same topic. Let’s see if it, too, presents positive trial results of blarcamesine in the treatment of early-stage Alzheimer’s. If so, it will be a strong, second validation of the Anavex drug.
The referenced webpage and the new abstract are now available for public access and consideration. There will be lots of Alzheimer’s scientists reading the paper closely. Blarcamesine can no longer be swept under a rug of disbelief.