Anavex Life Sciences Corp (AVXL)

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Doctor, Some of Us Do Understand

...2-73 may get approval for broad neurological indications.

It is my belief that the science of 2-73 (and 3-71) is way beyond where the market is at present in understanding the future value and potential of this company.

A few of us share this “belief.” In fact, for the few who know and understand the cellular chemistry of neurons, it is beyond mere belief. It is sound, fact-based, understood science.

The mechanisms of action of the Anavex molecules are unique. No other drug shares their unique abilities to restore disrupted intracellular structures and processes. Anavex is New Science; New Medicine. Nothing previous compares. Those who have failed to read the numerous papers on Anavex science; or, who can’t understand both their complexities and implications, have no real understanding of how Anavex promises to change vast segments of 21st-century medicine.

Understandably, the majority of those attempting Anavex due diligence see only the exposed surfaces of the topic. The following are easily perceived or understood:

1. The company is attempting to successfully treat severe neurological diseases that have chemotherapies of only marginal efficacies. Presently, therapies for Alzheimer’s, Parkinson’s, multiple sclerosis, Rett syndrome, et al. are woefully lacking. Therefore, it is a stretch to think this small company could devise and bring successful treatments for any of them.

2. Further, many much larger, much better funded drug companies, for long periods of time, have tested numerous new drugs for these diseases. Each has failed. On the face of it, there is no reason to believe Anavex could or would be any different.

3. Unlike the large pharmaceuticals that sponsored and conducted all of the previous failures, Anavex is a tiny, new company, with but a few employees, no manufacturing capabilities, no sales force, with nothing approved to sell. It is but a bit more than a mere shell, with, perhaps, a few questionable patents. Too small, not enough funds, not enough expertise, to possibly bring a neurological treatment drug to FDA approval and to clinical use.

4. The company did tell of very promising human results in an early clinical study assessing safety and tolerability. But those results, in that preliminary study, are presumed by Anavex critics to lack statistical significance. Too few participants for statistical significance; even, perhaps, corporate misrepresentations of the data.

5. “Promised” new clinical trials have failed to appear in a timely manner; indicating a deeper corporate misfeasance. Anavex evokes hope and promise, but, so far, has failed in generating any new clinical data to support the hope and promise. So far, just words.

6. With all of this, Anavex can be no more (probably less) successful than any of many previous start-up biotechs that all failed. There have been many of these; young, new, tiny companies with some new drug or procedure — The Next Big Medical Thing. Each has failed. Such will be the case with Anavex, it can be presumed.

If all of these points are even partially true, with no other contravening factors, the Anavex story will end, as will the company. But, as those who have studied and understood the multitude of peer-reviewed papers on Anavex molecules understand, there are unique, contravening factors:

1. Anavex is targeting neurological diseases because unique, proprietary molecules in their pipeline successfully treat a number of central nervous system diseases. Treatment outcomes in both murines (rats and mice) and humans authenticate Anavex efficacies. The Anavex science actually works.

2. Anavex science involves unique, well-described and now well-understood mechanisms of action, where (in brief) the molecules easily cross the blood/brain barrier, readily enter neurons, and there, re-connect dissembled organelles, thereby restoring a number of intracellular feedback and response (homeostatic) processes of normal function.

3. Both murine and human studies reveal very facilitative, low rates of adverse events, side effects. Side effects detected in humans were low-grade, of no severity to obviate FDA approval or general patient usage.

4. Anavex 2-73 is metabolized in the cell into at least one active metabolite, with a markedly longer intracellular half-life and probable elevated therapeutic efficacies.

5. Anavex 3-71, at least for some indications generates data of even greater significance and efficacy than 2-73. Applications for any number of indications await further study. Existing data, primarily from murines, show very favorable applications.

5. With all of this; safety, efficacy, against a number of central nervous system diseases, particularly those many involving mitochondrial dysfunction, Anavex Life Sciences Corp has the realistic potential to change 21st-century medicine as much as antibiotics did in the last century.

6. A similar technological progression. When Fleming discovered penicillin, his initial findings were regarded as mere lab curiosities. At the time, smart medical minds “knew” that infections could be chemically treated with only two difficult, even toxic elements: Hg ions (in mercury compounds), or, in high concentrations iodine ions. That was it. They worked, sort of, but were very toxic. Today, similar perspectives on CNS diseases. A few drugs “work,” to a degree, but there can be no anticipation of anything better.

7. With penicillin’s dawning of the antibiotic age, subsequent study and discoveries yielded both new antibiotics, and, moreover, expanded understandings of infectious diseases and immunological function. In the same way, Anavex science is likely to generate entirely new classes of function-restoring drugs against a yet unknown number of disease families.