Wednesday, October 02, 2019 1:11:58 PM
In the last few years, a number of seemingly plausible reasons Anavex Life Science Corp and its drugs could never succeed have been posted and deliberated upon. Now, with the new patent concerning the manufacture of Anavex 2-73, another matter is settled. Coming to mind are these former issues:
Negative #1. Anavex 2-73 targets severe central nervous system diseases; none of which have or can be successfully treated by a drug.
Yes, billions of dollars have been spent (by others) trying to bring to market any number of new drugs to treat Alzheimer’s disease. Each was a failure.
BUT NOW: A few Australians with Alzheimer’s have been taking Anavex 2-73 for about five years (or less), and have elected to continue taking the drug. Therapeutic results are better than any of the few existing Alzheimer’s treatment drugs.
IN FACT: Anavex 2-73 does, indeed, successfully treat Alzheimer’s. For regulatory approval, the drug needs to complete larger, on-going clinical trials. But there is not a scintilla of evidence that any of the trials will be unsuccessful.
Negative #2. The company’s targeting of Parkinson’s Disease Dementia cannot be successful, for the same reasons regarding Alzheimer’s. No good reason to believe the drug could work against this form of Parkinson’s; therefore it won’t be successful.
BUT NOW: In Spain, a clinical trial progresses with Anavex 2-73 against Parkinson’s Disease Dementia.
IN FACT: Results from that trial will appear in 2020.
Negative #3. Because it’s of genetic, chromosomal origin, an attempt to treat girls with Rett syndrome with Anavex 2-73 is doomed to failure. It will be impossible for the drug to restore the missing chemicals that cause Rett syndrome symptoms. The genetics and biochemistries of Rett syndrome nerves are far too disrupted for a mere 5mg daily dose of Anavex 2-73 to induce any positive result.
BUT NOW: Six older girls (adolescents or older) were safely treated with Anavex 2-73.
IN FACT: Rett symptoms were improved in all, with no obviating or complicating side effects; all within a short treatment period.
Negative #4. In order to treat central nervous system diseases, the Anavex drugs must have some remarkable, presently-unknown mechanisms of reaction. How the drug could positively effect a wide range of nerve functions, it’s MOA (mechanism of action), is not and cannot be known.
BUT NOW: The MOA of Anavex 2-73, a sigma-1 receptor agonist, is now known and understood.
IN FACT: The molecule facilitates, controls a number of cellular activities at their physical and chemical origins, which favorably cascade downstream (as it were) to a diversity of normalized outcomes; cellular homeostasis is the descriptive term.
Negative #5. Nerve-acting drugs, with the fewest exceptions, have diverse and severe side effects. The safety of Anavex 2-73 is unknown and highly questionable.
BUT NOW: After years of Anavex 2-73 treatments, in both murines (rats and mice) and in real humans, side effects in every case have been very moderate, of no obviating intensity or duration.
IN FACT: The only Anavex 2-73 side effects have been some initial occurrences of headache or stomach distress; all of which appeared to promptly resolve. Safety is not a confounding factor.
Negative #6. Sure, a host of murine studies with Anavex 2-73 have shown remarkable therapeutic outcomes, for a variety of diseases and debilities. But those results can’t be confidently extrapolated to real people. Without human trials, the murine studies are worthless.
BUT NOW: Human clinical studies are being conducted for three CNS diseases: Rett syndrome, Parkinson’s Disease Dementia, and Alzheimer’s Disease.
IN FACT: Humans are now displaying positive Anavex therapeutic outcomes, just as did the rats and mice in the pre-clinical studies. The murine studies of Anavex 2-73 DO extrapolate to humans.
Negative #7. Even if Anavex therapies work in humans, the company’s ownership of the intellectual property rights of the molecules is doubtful. With that unresolved matter, corporate success remains highly questionable.
BUT NOW: Anavex Life Sciences Corp has just gained a patent on the useful manufacture of Anavex 2-73.
IN FACT: The company now owns the rights to the most important patent; how to successfully manufacture the drug. With that, they effectively hold all of the commercialization cards.
What have I missed? What other matters or factors, now resolved, have I not listed?
Anavex Life Sciences Corp has at least these seven ducks in line, waddling forward to success — soon to jump safely, commercially into the CNS treatment pond.
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