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Key Near Term Pipeline Updates:
Alzheimer’s disease: Full data ANAVEX®2-73-AD-004: Potentially pivotal Phase 2b/3 clinical trial
Parkinson’s disease dementia: Data of 48-week OLE Phase 2 study
Parkinson’s disease: Initiation of ANAVEX®2-73 imaging-focused clinical trial
Fragile X: Initiation of potentially pivotal ANAVEX®2-73 Phase 2/3 clinical trial
Schizophrenia: Initiation of ANAVEX®3-71 Phase 2 clinical trial
New Rare disease: Initiation of potentially pivotal ANAVEX®2-73 Phase 2/3 clinical trial
Publications:
Several clinical publications involving
ANAVEX®2-73,
ANAVEX®3-71
and Rett syndrome Burden of Illness study
NONSENSE
In over 38 years Big Pharmas or, biotech companies that focused exclusively on the plaque/tau none have been successful in their treatment of the disease of AD. Even our FDA in desperation to find a meaningful approach to this catastrophic disease approved 2 Biogen drugs that do little to alleviate the significant issues of the disease ... plus their drugs are very expensive, must be given I.V. and must be done by medical personnel ... adding more expense for the treatment .... and the treatment can cause the patient's brain to bleed, which could result in the patient's death. Summed up, just more failures with this dangerous approach.
Am awaiting the approval of Anavex's blarcamesine drug/2 - 73, a safe drug, a pill taken by mouth, that has demonstrated significant results with neuro-degenerative and neuro-developmental diseases affecting the CNS.
The Scandal Of Alzheimer’s
Steve Forbes Forbes Staff
“With all thy getting, get understanding."
Feb 7, 2023,06:00am EST
Why is there no cure for Alzheimer’s—or why aren’t there medications that can at least substantially slow or meaningfully ameliorate the disease? It afflicts more than 6 million Americans, with that number on its way to doubling within a generation.
Alzheimer’s is a hideous ailment for both the sufferers and their families and friends. Yet even though the disease was first diagnosed by psychiatrist Alois Alzheimer in the early 1900s, progress in fighting it has been almost nonexistent. What’s scandalous is that for decades research has been almost entirely focused on the wrong hypothesis.
Dr. Alzheimer noted in the autopsy of the patient’s brain with the disease that came to bear his name that it was densely loaded with two proteins called plaques and tangles. Unfortunately, the dominant thesis in research on the disease has been that attacking plaques, and to a lesser extent tangles, would cure the ailment and enable the brain to regain its health.
Alzheimer himself warned about focusing too much on plaques and tangles as causes. In fact, some sufferers of Alzheimer’s have proved to have had little in the way of plaques, while others who had plaques didn’t have the disease.
Nonetheless, despite constant failures—some 20 drugs have been developed that ended up as flops—and the expenditure of tens of billions of dollars, the main thrust of research remains focused on fighting plaques.
The obsession with this dead-end approach has been fanatical, almost cultlike. Researchers who want to pursue more promising avenues have faced serious obstacles. Rarely has chronic failure resisted correction on something so important.
You may have heard of a new drug called lecanemab, which is being heralded as a fantastic breakthrough. But lecanemab is based on the wrongheaded plaques hypothesis. As noted health policy journalist Joanne Silberner sadly points out, “At best, lecanemab might slightly slow a patient’s inevitable decline for a few months.”
This research scandal shows the danger of groupthink, particularly when there’s a powerful government agency such as the National Institutes of Health putting the kibosh on grants for nonconsensus projects.
A classic case of similar groupthink involved the cause of stomach ulcers. The once-prevailing view was that stress and lifestyle were the cause, and drugs and regimens were developed on that belief.
This dogma was challenged by two Australian physicians, Robin Warren and Barry Marshall. They posited that the villain was bacteria and that antibiotics were the answer for a permanent cure. When not ignored, their discoveries were derided. Only after many years and constant, sometimes unorthodox advocacy, especially by Dr. Marshall, did the medical world accept their truths. The two were eventually awarded the Nobel Prize in Medicine.
In the case of Alzheimer’s, the rigid research mentality has begun to soften, but only slightly. To attack this deadly rigidity, Congress should hold hearings on the subject, starting with the leaders at the National Institutes of Health.
Steve Forbes is Chairman and Editor-in-Chief of Forbes Media.
https://www.forbes.com/sites/steveforbes/2023/02/07/the-scandal-of-alzheimers/?sh=34284da66a41&bsft_aaid=a4679c91-eb03-4591-93c2-79b7f25f9cbd&bsft_eid=15374f1b-1165-4402-b482-cdabfc723dde&utm_source=blueshift&bsft_clkid=39bb3ca5-f842-4f84-a918-78a3d2514c58&bsft_uid=8a4ab049-cac4-4359-ae99-bc1e70d3b870&bsft_mid=6fae9050-ef21-411e-9d1c-4e5f7b0849ca&bsft_utid=8a4ab049-cac4-4359-ae99-bc1e70d3b870-DRPROOF&bsft_mime_type=html&bsft_ek=2023-02-07T21%3A30%3A36Z&bsft_lx=20&bsft_tv=4&pk=ce01a6586b8394cd219d9d4151b05359&utm_campaign=DAP_ISSUE_02.07.23&utm_medium=email&vid2=9cd562d8abdeeda86039a61cc7e5dc63e585d49a727e626584f7ccd81870dffd80f6507937c7784a56ba72af38c88171
I guess investors forgot BlackRock,Inc bought 5.5 million shares of Anavex Life Sciences common stock for a reason that they believed it was a very, very, very good investment for their customers. Maybe other investors might now become a bit more savvy? After all BlackRock,Inc. is a fiduciary whose current value in it's stock positions exceeds $8.6 Trillion Dollars ... that figure IS NOT A TYPO ............
This will give Anavex the flexibility to raise cash as needed without selling their soul to an investment Bank. This continues Dr.M's independence from Wall Street. Some people will view it positive some negative. When a capital partner has done well in the past, as LPC has, you keep the relationship going. LPC obviously finds no problem placing the shares.
Cantor Fitzgerald is probably pissy they didn't get the business hence their low price target. Investment bankers are a truly petty egoist bunch.
Kund...LP will pay how much per share under this agreement?? Market price at the time of purchase??
What is the date on that contract for 3-71?
Dr. Missling mentions brain atrophy - as we know, Lecanemab patients saw SIGNIFICANT brain atrophy, especially in the hippocampus. Looking forward to this data and hopefully some comparative charts.
“Obtaining exclusive worldwide rights to this intellectual property is exciting as it is another step in Anavex’s overall strategy to build a broad and leading platform of technology and intellectual property for the development of mixed muscarinic and sigma-1 therapeutics. It also adds to our already dominant position in this field,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “By adding AF710B to our pipeline of Alzheimer’s and neurodegenerative drugs, we have another strong small molecule that comes with a very convincing package of preclinical validation. We look forward to advancing AF710B further into the clinic after the required toxicology studies.”
Under the terms of the agreement, Anavex gains exclusive development and commercialization rights for AF710B worldwide. Anavex has agreed to make an upfront payment and LSRI is eligible to receive milestone payments. LSRI may also receive royalty payments, assuming regulatory approval and commercial launch.
Only a projected 350% increase over todays price.
Maybe I should buy some crypto instead.
Simple Notes from Conference Call:
- Fragile X trial to take place in USA; talks with FDA recently conducted.
- Dr. Missling is keen to get data off to the FDA and EMA (European regulators mentioned a few times). I discuss this with Dr. Grimmer.
- Strong language indicating cross-CNS platform. I discuss this with Dr. Grimmer.
- Rett Syndrome Burden of Illness presentation mentioned for the first time in a long time - indicates the company will tie patient improvement to parent/caregiver greatest concerns.
- Dr. Missling mentions brain atrophy - as we know, Lecanemab patients saw SIGNIFICANT brain atrophy, especially in the hippocampus. Looking forward to this data and hopefully some comparative charts.
- Reaffirms S1R as important to patient efficacy. I discuss S1R as a biomarker with Dr. Grimmer.
- Very much so looking forward to PDD OLE. I discuss PDD briefly with Dr. Grimmer.
AVXL stock trading volume exceeded 2 million shared traded TODAY 7 February 2023.
Good luck and GOD bless,
The Cantor Price target also needs to be put into context that the contract was drawn up in 2018 at below $5. Sometimes 100% targets get met... They will be back in another financing round someday in the far future and the "Strong Buy" will be right back on.
Some ancient history for you:
https://www.sec.gov/Archives/edgar/data/1314052/000161577418006280/s111267_8k.htm
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Anavex®Life Sciences Corp. (the “Company”) is a clinical stage biopharmaceutical company engaged in the development of differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental diseases including drug candidates to treat Alzheimer’s disease, other central nervous system (“CNS”) diseases, pain and various types of cancer. The Company’s lead compound ANAVEX®2-73 is being developed to treat Alzheimer’s disease, Parkinson’s disease and potentially other central nervous system diseases, including rare diseases, such as Rett syndrome.
Anavex®Life Sciences’ lead drug candidate, ANAVEX®2-73, recently completed successfully a Phase 2a clinical trial for Alzheimer’s disease. ANAVEX®2-73 is an orally available drug candidate that restores cellular homeostasis by targeting sigma-1 and muscarinic receptors. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer’s disease. It has also exhibited anticonvulsant, anti-amnesic, neuroprotective and anti-depressant properties in animal models, indicating its potential to treat additional CNS disorders, including epilepsy and others. The Michael J. Fox Foundation for Parkinson’s Research has awarded Anavex® a research grant to develop ANAVEX®2-73 for the treatment of Parkinson’s disease to fully fund a preclinical study, which could justify moving ANAVEX®2-73 into a Parkinson’s disease clinical trial. ANAVEX®3-71, also targeting sigma-1 and M1 muscarinic receptors, is a promising preclinical drug candidate demonstrating disease modifications against the major Alzheimer’s hallmarks in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid and tau pathologies, and also with beneficial effects on neuroinflammation and mitochondrial dysfunctions.
The Company is in preparation for ANAVEX®2-73 for a Phase 2/3, placebo-controlled trial in Alzheimer’s disease as well as a Phase 2, placebo-controlled trial in Rett syndrome, for which the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) for ANAVEX®2-73 and a Phase 2, placebo-controlled trial in Parkinson’s disease.
Headquartered in New York, Anavex® Life Sciences is an American publicly traded corporation on Nasdaq quoted as AVXL
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