dmb2
3 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
3 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
3 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
dmb2
4 months ago
The CEO is very openly bullish and since she is a lead researcher of the compound she has some credibility. In the past it has not been wise for a CEO to speak so openly about anecdotal responses but in this market place with such financial pressure by shorters there needs to be some tools or tactics for CEO's to use to support a fair valuation of their shares.
This is a fascinating compound, from its design to its MOA to its recent P2 data, though limited in volume. I place some weight on the 54 PD patients data since it is a reasonable mid size sample size to attain a starting point for stats. I don't think I have ever seen such a strong stat performance from such a small sample population, which is eye opening. The observations of rapid enrollment and low drop out rates in both trials are indicative of trial physician support and at least patient safety success.
The contradiction here is that the MOA is superbly simplistic and holistic as far as neurodegeneration is concerned but the logic of its approach gives one the initial impression that there is no way Big Pharma could have missed this approach. But BP can be blinded at times and it takes years to decades to modify their approach. This approach seems too simple, but this would not be the first such example of a simpler approach being correct since the scientific achievement is in finding how to make the simpler approach a reality. This compound's MOA helps to explain why there have been other single degenerative protein approaches which have demonstrated limited temporary success only to completely succumb in the longer term as only one degenerative protein is being controlled by the other compounds while the other degenerative proteins continue to agglomerate in the brain. This means there exists synergy between the decades long BP approaches and this one.
The alignment of all the preclinical through early to mid clinical data is consistent but in the field of neuro there are hurdles of proof in cognitive testing, which is why Parkinsons mobility is a great complement to evaluate concurrently with AD cognition. I see this as an interesting SWAG at this stage as there is compelling data but not a lot of it, otherwise the company would already be in the billions. Not many small companies, though I know of one in oncology, can offer such potential value. This compound, like the other company I reference could bring medical science revolution to the market. The benefit this company has is a shorter development timeline than the other company, more traditional trial metrics, and it has not garnered the destructive attention of large shorting entities. The timeline here now does not allow for large shorting games and the potential upside value is too significant of a risk given the low float.
All in all this is still a binary investment situation but there is a strong positive case for a potentially successful outcome in a medical field where all have failed to date, except a few very limited successes. Patenting the newly developed crystalline form of the compound for IP purposes in addition to added stability is a positive. I think, given the safety profile that will be available and the proof of the MOA post both the PD and AD trials in coming months if both trials are successful, the FDA will be receptive to an accelerated approval pathway, at least that would be logical and patient serving though it is possible there may be additional P3's in both indications required, strength of results may be the determining factor.
GLTA
grich1
4 months ago
Excerpt from 2021 article regarding Parkinson’s trial.
“I don’t want to sound cocky, but I really do not see any challenges ahead for our Phase 3 trial,” she says. “Patients are required to take one pill a day. It is a small dose with no side effects. I have also heard great feedback from patients. One Parkinson’s patient emailed me a while back. He was in his second Phase 2 trial and was not seeing any improvement. When that trial concluded he was able to try our treatment in a third Phase 2 trial. After just two weeks he contacted me to tell me that it worked. Several other patients did so as well. They reported better memory, coordination, and attention span with less shaking. We believe we will see similar results in our Phase 3 trial. We will present our data to the FDA in September and plan to start the Phase 3 trials for both Alzheimer’s and Parkinson’s this winter.”
Might be the reason CEO and Insiders are buying. A lot of drugs are in clinical for multiple indications but how often do they talk about better cognition as a side effect?? Rett, MS, trials? Several Parkinson’s patients are commenting on cognition.