dinogreeves
4 weeks ago
"This month, the FDA issued guidance on developing drug treatments for early Alzheimer's disease, a must-read for all $ANVS investors. The FDA emphasizes significant clinical improvement as the key outcome. If trials show clinical improvement backed by biomarker data, companies may seek traditional approval. If only biomarkers show improvement and clinical benefits need more time to manifest, accelerated approval might be pursued, contingent on further trials. This aligns with $ANVS's strategy of prioritizing clinical improvement as the primary endpoint in its PD and AD trials. I'm optimistic about the potential for approval based on upcoming PD and/or AD trial outcomes. While longer trials are anticipated, impressive results could pave the way for submitting approval applications almost immediately post-trial. The company has stated that they will meet with the FDA shortly after the trials are read out. It will be very interesting to see if they're given the ok to apply..."
dmb2
4 months ago
Awful experience, great that you survived it. I don't like the rot in our large govt systems such as our medical system, which is one that jeopardizes everyone if not conducted well, as you experienced. I hope some day we can achieve a continual improvement mindset of sound and active system monitoring over our medical system which can address high costs and insufficient care in many cases. I saw the extent companies go to reporting adverse events and side effects of marketed drugs and FDA cannot properly monitor and utilize this mountain of data, though there are significant learnings buried there. And the learnings can be applied to research of new therapies as well. Every area of medical research and practice could be advanced more intelligently and in more integrated fashion, AI may help but we do not have to wait for nor rely on that. As time goes by we see that any system that does not continue to progress and improve will start to decay, especially as size and monetary flows grow. Thx for sharing and great you survived but awful that you experienced it.
XenaLives
4 months ago
My personal experience - flouroquinolones did it.
I was given FQ antibiotics for a fungal infection (idiotic, in retrospect) I had an adverse reaction, died, was resuscitated.
Then I was told that the resulting hypoxic brain damage was psychiatric and given more drugs that I couldn't tolerate.
Bottom line - it's a system that rewards Doctors for giving toxic treatments that is the problem.
Vaccines, COVID - not going to go there but the abuse is egregious.
FQ toxicity is probably a function of genetics.... but they don't test for it. So Ancestry.com will reflect a genetic pattern but it's actually a toxic drug that causes it.
"Research" like this makes me want to scream...
Multidrug resistance seen in bacteria today is one of the global threats as recognized by WHO. Misuse, overuse, and poor hygiene or infection control practices have all contributed to this rising problem [37]. Hence, repurposing clinically approved antibiotics for the treatment of other diseases would be economical and spare the redundancy of antibiotics. Some of the antibiotics, such as rifampicin, minocycline, benzylpenicillin, doxycycline, and bleomycin have shown anti-amyloidogenic activity, with rifampicin reaching clinical trials. This has prompted us to study another antibiotic for its anti-amyloidogenic behavior [[38], [39], [40], [41], [42], [43], [44]].
Levofloxacin is a fluoroquinolone (Fig. 1) with bactericidal activity against Gram-positive and Gram-negative bacteria including Mycobacterium tuberculosis. Emergence of levofloxacin-resistant strains of bacterium have been reported [[45], [46], [47]]. Levofloxacin has a favorable cerebrospinal fluid penetration and expected blood brain barrier penetrability [48].
Because of these properties, we investigated the possibility that levofloxacin could be effective in interfering with the amyloid formation by human lysozyme. We first investigated the possible mechanism of action of levofloxacin in this regard by detailed biophysical in vitro studies and computational analyses involving molecular dynamic simulations and docking, and further extended those studies by testing the effects of levofloxacin on the cytotoxicity of lysozyme aggregates using human red blood cells.
https://www.sciencedirect.com/science/article/abs/pii/S000398612100326X
dmb2
4 months ago
Neuro-degenerative diseases are like using Ancestry.com, the further you go back the complexity is geometric. Each stage causes the next successive stage so you could say each stage is causative of the next stage. Ultimately these diseases may be deeply understood as to what causes the first stage of degeneration but there may be simple answers in some cases like old age, yet more complex answers in others like genetic disposition and/or other related triggers. I suspect we are still decades away from connecting all the dots, and even when we do, the approach to managing the disease may not be to address the first stage but to address a stage which we can affect more efficiently.
This is a complex space with so much work to do, with advances coming mostly through the set of small companies with good researchers who continue to progress. The ANVS approach is another fascinating one in a space desperately in need of solid progress toward effective treatment, even if not yet addressing the initial root cause stage.
Jan readout will determine if this approach is progress or not, I am bullish as I am with other small companies advancing this field, like all people I have seen people affected by these terrible diseases. My observation is this company has a well done body of research behind its approach though as with all small companies the depth is limited, especially the clinical data, with only the 54 patient PD data providing data strength. But all is aligned from compound design to clinical data so hopefully real progress will be made.
GLTA