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Sent Gates Foundation Our CTAD PDF
For what it's worth, I just sent a short note (<500 characters) to the Gates Foundation, asking that Bill Gates' people scrutinize the Anavex CTAD presentation.
Anavex 2-73 is exactly the drug Mr. Gates is searching for, matches all of his search and selection criteria.
Don't hold your breath, but let's see if anything comes of this.
I left my real name, address, and contact info. For good Bill (with no bill), I'm not anonymous (nor just a falconer).
Our Traits Posting Now at Institute
I just emailed the lead researcher, an author of the paper, at the Sanford Burnham Prebys Medical Discovery Institute, listing the Five Traits posting.
Importantly, I offered the CTAD presentations PDF, where his team can scrutinize the presented data and references.
Thanks for the clarification. No Results, No Pay
Thanks for clarifying the continuation of the Australian trial.
Crucial, defining factor is this. Would the Australian government be paying for the trial's continuation if the participants didn't continue to benefit in very clear ways?
Again, real people. Real results.
Anavex 2-73 works.
Wanna play a mythical hand of poker, betting on the upcoming Phase 3 trial?
Study Supports Anavex MOA. They Need Anavex 2-73
A new study, investigating how endoplasmic reticulum dysfunction can cause waste protein accumulations that cause Alzheimer’s symptoms, fits exactly the Anavex mechanism of action (MOA).
Previous studies have suggested that ERAD [ the mechanism by which cells get rid of proteins that are folded incorrectly in the ER ] contributes to many diseases where cells become overwhelmed by an irregular accumulation of proteins, including Alzheimer's," says Xu. "This study provides conclusive, mechanistic evidence that ERAD plays an important role in restraining Alzheimer's disease pathology. We now plan to search for compounds that enhance production of membralin or the rate of ERAD to test whether they ameliorate pathology and cognitive decline in models of Alzheimer's.
Company Makes No Claim---People On Drug DO!
Of course, by the protocols of clinical trials statistics, SEC rules, etc. no one in Anavex Life Sciences Corp can come right out and claim that Anavex 2-73 holds or improves Alzheimer's symptoms at length just yet (although they know it does).
Legal rules don't affect the actual results demonstrated in real people. The realities of actual people taking the drug for now for over two years, and legal and regulatory protocols are at odds.
The fact is this: it appears (in the company CTAD presentation) that the majority, if not the entirety of the Australians with mid- to mild-level Alzheimer's disease in the Phase 1/2 clinical trial have elected (as allowed and provided for in proper clinical trials) to continue to take Anavex 2-73 after the company stopped taking clinical data from them.
And this was not but for a few weeks. It continued, as indicated in the CTAD presentation, for a period of at least 107 weeks. (And it most likely continues, to this day.)
The essence of the matter is this. If Anavex 2-73 had no perceptible good outcomes, there is no reason those original clinical trial participants would have deliberately requested to continue to accept and take the drug for the many months after the first portion of the trial terminated --- unless the drug actually provided useful therapeutic outcomes. Which, it did, matching and continuing the documented symptomatic stabilization documented during the first trial period itself. (Again, confer the CTAD data presentation: http://www.anavex.com/my_uploads/Anavex-ANAVEX2-73-CTAD-Phase-2a-November-2017.pdf )
Of course, some (so foolishly) will claim that the predominance of good results in the Australians continuing to take the drug are mere statistical happenstances, that merely by chance alone those people just happened to be particularly and rarely amenable to the Anavex therapy; that in any larger population, as in the upcoming Phase 3 study, far fewer will gain any relief from the drug.
I'd love to play poker with anyone who believes all of the benefitted Aussies were merely by-chance strange and non-representative outcomes, that they didn't represent the real deal in any larger cohort.
Somebody Send Gates My Anavex Traits Posting
I doubt Mr. Gates is familiar with Anavex Life Sciences Corp, nor knows of Anavex 2-73 and its demonstrated prospects of solving the otherwise intractable Alzheimer's problem.
Send him this posting:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=136043064
Concisely lays out the important traits. Unlike anything Gates will be reading or learning about any other drug or therapy.
Parkinson’s Disease Increasing — Epidemic Is Claimed
Parkinson's disease: A looming pandemic
"Pandemics are usually equated with infectious diseases like Zika, influenza, and HIV," said Dorsey. "But neurological disorders are now the leading cause of disability in the world and the fastest growing is Parkinson's disease."
In their commentary, the authors point out that between 1990 and 2015, the prevalence of Parkinson's more than doubled and it is estimated that 6.9 million people across the globe have the disease. By 2040, researchers believe that number of people with Parkinson's will grow to 14.2 million as the population ages and the rate of growth will outpace Alzheimer's. These estimates are likely conservative due underreporting, misdiagnosis, and increasing life expectancy.
I Was Wrong, Anavex in the Table
I was in error. I didn't see Anavex listed in any of the paper's text; but it's in a table. Nothing new on it, just what we know. Page 370
But nice to be listed. The rest of the Alzheimer's research and treatment community need to learn of the Anavex details. Has more promise than anything referenced in the paper.
https://www.researchgate.net/publication/320161874_The_present_and_future_of_pharmacotherapy_of_Alzheimer%27s_disease_A_comprehensive_review
Not A Word on Anavex Mechanism of Action
No, it is not a complete compendium of Alzheimer's research or treatment modalities. Not a mention of Anavex or any sigma-1 receptor agonists.
Just a listing of all the failures.
Yes, What if...?
Australia should come through!
Metabolites Usually Included in Patent Language
Does 2-73's metabolite have patent protection?
Yes, Sigma-1 Receptors Reduced in Early-stage Alzheimer's
Thanks for posting this. I read the paper. Clear evidence that:
...the density of cerebral and cerebellar sigma1 receptors is reduced in early AD.
Once Again, The Anavex Sleep Factor
Noticed this morning a short notice from the Society for Neuroscience summarizing recent and continuing findings about the importance of sleep:
Although the general benefits of a good night's sleep are well established, one-third of American adults do not get a sufficient amount of sleep. Recent research sheds new light on the extensive effects of sleep on the brain, as well as the harms caused by sleep loss. The studies were presented at Neuroscience 2017, the annual meeting of the Society for Neuroscience and the world's largest source of emerging news about brain science and health.
Adequate restful sleep leads to improved cognitive function and enhanced memory formation, while insufficient, restless sleep has harmful effects such as impaired memory and judgement, and can lead to increased risk for medical conditions such as stroke, obesity, and cardiovascular disease.
Makes No Sense
"they have NEVER found a sigma-1 agonist to be druggable by itself ever."
Five or Six Contaminated Petri Dishes
...so far we're talking about 5-6 patients from an open-label trial without placebo.
Good, Tell “Why Not?”
Please, tell us science-based AVXL longs just why Anavex 2-73 won’t achieve, for either Alzheimer’s or Parkinson’s (or Rett), eventual FDA approval. Or, are shorts just guessing?
We are delighted that you are humored (“LOL”) with our notions of eventual, certain Anavex success.
But we would like to know the basis of your delight. Tell us, for example, just what will keep Anavex from eclipsing the current Standard of Care hurdle required for FDA approval of a new Alzheimer’s drug?
We know you’ve studied all of this thoroughly, that presently there are only four FDA-approved drugs for Alzheimer’s. To get approved for the disease, Anavex 2-73 has to exceed only these two existing Standard of Care traits:
1. Demonstrate equal or surpassing safety of the present SOC drugs.
2. Demonstrate equal or surpassing treatment efficacy over the existing SOC drugs.
AVXL shorts, in their so-questionable wisdom, somehow think that both of these hurdles will not be crossed by Anavex Life Sciences Corp in the upcoming clinical trials.
Let’s let questioning readers scrutinize the issue. What is the strength of the short argument, that there is no possibility that Anavex 2-73 can ever get approved for any of the three target diseases, that the company will fail and short positions will pay off big (and not have to chase ever more expensive cover positions in a classic short squeeze)?
1. SOC Safety Threshold. Aricept and the other three Alzheimer’s drugs have FDA approval. They have acceptable safety profiles. For Anavex, there is the very favorable safety profile derived from 107 weeks of Australian Alzheimer’s patients on Anavex 2-73. No adverse events greater than Levels 1 and 2. No adverse events negating eventual approval.
Anavex 2-73 has shown a remarkable safety record, in both over-dosed animals and properly-dosed humans.
Not a whit of evidence that safety issues will disqualify Anavex 2-73. Quite the opposite.
2. SOC Efficacy Threshold. This is even easier. Existing Alzheimer’s drugs, at best, hold symptoms stable for only short periods of time (no more than 2 yrs; usually for only a few months).
Anavex 2-73 has demonstrated the ability to hold symptoms stable, or even reduce them over long periods of time; greatly exceeding the meager efficacies of Aricept and the other existing Alzheimer’s drugs.
Shorts, you might consider all of this a carefully worded and well-intended caution. Both Anavex science and FDA approval standards are on the side of Anavex 2-73 approval, by wide margins. “Near certain,” in fact.
Again, tell us why not. Reason, or hope? We are looking for the facts. Tell them, please.
Not What Anavex Neurochemists Claim
I think protein more typically gets misfolded due to ROS and RNS damage, moreso than too little ATP being made to fold the proteins.
Only If Anavex Is Trying the Same Approach
...aint too hard to understand the rationale behind shorting AVXL. Odds are against successful trial.
Receptors Sustained With Age, But Organelles Disconnect
Do the sigma-1 receptors diminish with age or does the occurrence of a CNS disease diminish them? Or maybe both.
New Label. New Team. New Stars
"Buy me some peanuts and cracker jack
Implications of Anavex for PTSD and TBI
Wow. Ponder the implications if, in fact, an Anavex pipeline drug has efficacy against Post Traumatic Stress Disorder, the hard-to-treat mental affliction of veterans in all wars. I needn’t lay out how these disorders ruin lives, both for the victims themselves, but concomitantly for family members, friends, and associates.
At the first hint, perhaps by Anavex at this Mental Health event, that Anavex 2-73 can usefully treat veterans with PTSD and TBI (Traumatic Brain Injury), there will be pubic discussion and consideration of Anavex, not as an obscure drug company startup, but as a provider of real mental health solutions.
The insistence for rapid use of our drug among afflicted populations of veterans is likely to be prominent, perhaps with front-page headlines and articles. “New Drug Company Has Drug to Treat PTSD.”
Let's watch.
Department of Defense Approval, Use?
...the Senate’s version of the 2018 National Defense Authorization Act would allow the Pentagon to sign off on unapproved drugs and medical devices.
Significance (?) Of Australian Trial Survivors
Someone mentioned, incidentally, the survivability of the Australians in the Phase 1 / 2 study, noting that apparently all were still requesting and taking Anavex 2-73 after 107 weeks on the drug. No apparent deaths or elective discontinuations.
Is this important? I think so.
But I tried to find data showing typical survivabilities of Alzheimer’s patients in mid- to mild-level stages, but could find no such data. Are the Australian trial participants exhibiting any increased survivability (no deaths, no elected drug discontinuations), compared to non-treated Alzheimer’s patients? Should a few of the 32 (or 25) participants have died if the drug had no therapeutic effects?
On the face of it, the fact that all participants have apparently elected to continue Anavex 2-73 treatment, and that none have apparently elected to discontinue treatment supports the notion that the drug is perceived by Alzheimer’s patients as beneficial.
If you had mid- or mild-stage Alzheimer’s and were taking an unknown, experimental drug for it, what would impel you continue to request it after the original contract trial period?
We’d sure love to see a current, retrospective listing of the treatment and symptom status of those first humans to take Anavex 2-73 for a lengthy period. Just why have so many hung on to the drug? Only one answer. They think it works for them.
And, if so, what might be the chances this would be the case in a much larger cohort, say 150 or so patients (as in the new Phase 3 study)? Were the 25 or so Australians, merely by scant chance, all unique “super responders” who don’t represent in any definitive way any larger population of Alzheimer’s patients?
The Alzheimer’s Problem in America
If you have three minutes, ponder the data presented here, telling the severe Alzheimer’s problems continuing to grow in America:
https://www.alz.org/facts/
The desperation for any effective solutions can only grow. Presently, in general public discussions, there are no solutions; merely anguished ponderings of the increasing intensities of the issue.
There are none yet, but it’s not unreasonable to anticipate increased inclusions of the Anavex story when it becomes better known and more fully authenticated by any of the three up-coming clinical trials . Anavex is not “in the air,” not yet with any general public (even professional) recognition. Those of us here who have done detailed, diligent consideration of the supportive scientific studies, both murine and human on the Anavex sigma-1 receptor agonists’ abilities to effectively address the problems of central nervous system diseases, particularly Alzheimer’s and Parkinson’s, are knowledgeable, conversant, and supportive of Anavex technologies. Few others, yet, are aware (or care).
As I’ve suggested previously, the Anavex Factor will enter the pubic Alzheimer’s discourse in due time, probably with the first release or unintended disclosure that the drug is having noteworthy effects on humans in any of the three upcoming clinical trials. How might it be reported in the general press when a number of Rett syndrome girls’ parents exclaim that, all of a sudden, their little girls no longer have epileptic fits and their control of arms and legs approaches normalcy?
What happens when many members of the public make public protestations to the effect: “Just why isn’t this drug available now? It’s safe, and it works. My Aunt Millie so much needs it!”?
Let’s watch, to discover when Anavex gains a much wider, public recognition and appreciation.
Vaccinations Are Mandated
No, a legal mandate to get tested for Alzheimer's would not be a "first."
People in most jurisdictions are still required to get tested for sexually transmitted diseases to attain a marriage license.
And school children (among others, in other venues, such as hospital employees) are required to get vaccinated.
There are legal mandates for disease detection and treatment. The law is rather settled on the matter.
A Health Insurance Premium?
If legal mandates for Alzheimer's testing and consequent Anavex 2-73 therapy were legally disallowed, would there be an issue if health insurance companies offered alternate policies; low-cost Pre-Test, Treat policies compared to high-cost No Test, No Anavex policies?
Health insurance companies have the potential to benefit better than Anavex Live Sciences Corp with the availability and use of Anavex 2-73 for Alzheimer's, Parkinson's, Rett syndrome, amyotrophic lateral sclerosis and who knows how many new conditions yet to be discovered amenable to Anavex therapy. Literally billions of dollars of health insurance expenditures will be saved with widespread use of Anavex 2-73.
Practically, the legal mandate issue is likely not to arise. Only a suicidal fool would elect not to be tested for Alzheimer's and take Anavex 2-73 as an Alzheimer's prophylactic. It's one thing to elect to not take the recommended annual flu shoot; quite another to elect not to be tested for pre-symptomatic Alzheimer's and get treated to prevent the debilitating onset of the disease.
Flu shota are shots, can have a brief "sting." Anavex 2-73 will be a daily pill. No sting. No hypodermic needle.
"Dr. I just turned 50. I want my Alzheimer's test! My grandmother died of the disease; don't want to go through any of that!"
Protein Plaques Not Universal, Other Pathologies At Work
I've read research that says that in some AD patients with cognitive impairment no or very little waste protein plaque was found.
Amyloid Plaques Appear “Downstream,” Anavex Works “Upstream”
“...if the peptide is a biomarker of AD present long before any signs of Amyloid, how could the Amyloid as causation rather than pathology be true? “
No, Merely Coincidental
...if true, disproves the Amyloid hypothesis, no?
Early Alzheimer’s Detection, Prospect of Prevention
Efforts continue to discover new ways to diagnose Alzheimer’s disease at ever earlier stages.
Here’s one, announced today:
"We have identified a peptide (DAG) that recognizes a protein that is elevated in the brain blood vessels of AD mice and human patients. The DAG target, connective tissue growth factor (CTGF) appears in the AD brain before amyloid plaques, the pathological hallmark of AD."
Unique Anavex 2-73 Traits
1. Unique, Effective Mechanism of Action. Anavex 2-73 addresses central nervous system diseases differently from any other drug currently or prospectively in use. It is a sigma-1 receptor agonist. There are a number of these, but none that work as effectively and safely as Anavex 2-73. The molecule causes dissembled rough endoplasmic reticula and mitochondria to re-connect and function collaboratively. It is well recognized that most CNS diseases involve mitochondrial dysfunction. Anavex 2-73 is able to re-establish the proper, healthful endoplasmic reticular/mitochondrial connection. With this, calcium ion exchange and adenosine triphosphate interchange (mitochondrion to the ER) can occur, restoring full, natural cellular functions, which result in clearance of the waste proteins (beta-amyloids, tau tangles) that cause Alzheimer's disease symptoms.
2. Ease of Administration. Anavex 2-73 is efficiently absorbed in the gastrointestinal tract, and once in the blood stream readily crosses the blood/brain barrier. This will allow for simple oral administration, no intravenous drip procedures. The blood/brain barrier restricts many drugs and molecules from nervous tissues. Propitiously, this is not a problem with Anavex 2-73.
3. Treats Upstream Portions of Alzheimer’s Disease. For Alzheimer’s, Anavex 2-73 targets upstream disease processes, obviating a multitude of downstream symptoms. Existing treatment approaches (all of which have failed) target the removal of the waste proteins, the beta-amyloids and tau tangles. Anavex 2-73 restores proper cell function, where enzymes can be once again synthesized (in the endoplasmic reticulum, using ample ATP from the adjacent, now re-connected mitochondria, etc.). Anavex 2-73 treats the upstream causes of Alzheimer’s symptoms, the dissembled ER and mitochondria, with no downstream complications (waste protein accumulations).
4. No Negating Safety or Tolerability Issues. Anavex 2-73 has demonstrated remarkable safety outcomes. In an early trial of Anavex 2-73 in Australia, the safety and tolerability profiles of the drug were very favorable. The only Adverse Events were at Levels 1 and 2, such as dizziness or headache. None of the adverse events were at a degree that would prevent or restrict the use of the drug to treat or prevent Alzheimer’s disease. This is uncommon. Most drugs treating neurological conditions have a number of side effects of negating consequence. Not so with Anavex 2-73.
5. Stops or Reverses Alzheimer’s Disease Progression. Anavex 2-73 a) stops or reverses the progression of Alzheimer’s cognitive decline, and b) maintains or improves cognition for at least 107 months. It does not lose efficacy during this time. Existing Standard of Care Alzheimer’s drugs do slow or, for a time prevent cognition decline; but only for short intervals (a few months to a year or so); whereupon the lethal course of the disease resumes. Additionally, clinical evidence shows that earlier administration of Anavex 2-73, before Alzheimer’s symptoms become fully burdensome, can keep the disease from degeneratively progressing. It has prophylactic capabilities.
Ok, without side effects of any negating consequence.
Here's the Applicable Statement on Anavex 2-73 Safety:
No serious adverse event was reported. There was no study discontinuation due to AEs.
Checked Protandim; No Connection With Anavex Target Diseases
There is currently a product called Protandem that fights Oxidative Stress owned by a public company with scientific trials DONE and proven. Unfortunately sold as MLM.
Both Are Correct --- Good Biology Explained Here
Blu and Mycroft have laid it out perfectly, telling the various mechanisms and effects by which Anavex 2-73 fixes malfunctioning neurons.
The Anavex 2-73 mechanisms of action are not, as some presume (Can't understand?) unknown and/or poorly characterized. Quite the opposite.
Importantly, the drug and its mechanisms of action are unique and proprietary. None other works as well, in the same way. No other company has a competing drug candidate. Simply, it works; wonderfully.
And, unlike most other nerve drugs, it is utterly without side effects. That is too often neglected in considering the drug's eventual FDA approval.
And, unlike many other drugs, it is easily absorbed, orally, readily crossing the blood/brain barrier. No need for IV drips, etc. One pill a day, at home, with breakfast.
Further, there is no drop off or weakening of individual patient efficacies for at least 107 months. That, too, is not typical of nerve-acting drugs. Usually, dosages have to increase, as efficacies start to fade in time. Anavex 2-73's benefits persist.
Altogether, with the rather certain good results of the final upcoming three clinical trials, FDA approval will highlight pharmaceutical events in 2018. The revolution of 21st-century medicine will begin. (We haven't seen the entirety of applications to be discovered and developed for all of the Anavex pipeline drugs --- another story too lengthy to go into here.)
A News Headline Would Be a Big Kickoff
What might be the results of a New York Times headline in the fashion of:
"New Drug Likely To Get FDA Approval: Fixes Alxheimer's"
--- with accurate text and graphics accurately telling the Anavex story.
Things going to be very different when Anavex is in public discussion. Won't take much to prompt such an article. First inkling of efficacy from the Rett or Parkinson's trials would do it. A bit later, several months into the big Phase 3 Alzheimer's trial, this time at optimized doses with well-matched, treatable participants, word starts to spread that a bunch of people are no longer experiencing cognition decline; a few are actually thinking almost normally again. And everyone is now sleeping soundly.
That trial is supposed to be double blind; but there can be no blinding of enduring cognition stabilization, or better, cognition improvement.
It could be very difficult to try to maintain blindness in both arms. Placebo? No problem. Experimental (optimized Anavex 2-73) arm? Will get harder and harder as the trial progresses. Hard to disguise improved cognition, improved sleep habits, etc. Family members will notice (and rejoice).
McGhan, For the Third Time?
Let's watch.
Michael McGhan will be running the new company. New viewers are encouraged to learn of the man's rather remarkable record with two previous oil industry companies. In short, he took both from rather small-time operations to billion-dollar entities.
As Before, No External Negative Posts
As with the established, continuing pattern, the only negative posts regarding the new Anavex data release are the expected meager postings from all the usual Anavex FUDsters.
I was eager to see new, informative interpretations of the new data released at the CTAD event. The handful of consistent Anavex naysayers have reiterated their statistical misgivings and defects in the Anavex data. Well and good. Fully expected and consistent.
Except... No one else has stepped in to affirm or elaborate on any of the laid out Anavex deficiencies in the well-known postings here. If the deficiencies are clear and strong, markedly calling into question the viability of Anavex Life Sciences, or negating any eventual FDA approval of Anavex 2-73, how come no one else, no one new, is writing about this?
Where are the new, external Anavex naysayers? New Anavex data, with new clinical trials should prompt, should they not, new commentators, particularly science professionals with competencies to accurately assess the Anavex story?
The silence of the matter it telling, is it not?
Please, professional readers who have surmised the new Anavex data, tell us what’s wrong with them; why Anavex 2-73 is as bad as certain posters here continue to proclaim.
New, Disruptive Things Discounted At First
...but why doesn’t Wall Street and the scientific community come out and have great things said about these results.
Third Big Finding: Aussie Data Will Faithfully Re-appear
Slide 33
That is confirmation that the sample of 32 patients of the Phase 2a provides reliable information regarding dispersion and as such allows for meaningful predictions for larger populations