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Saturday, December 3, 2022

Todays Stock in Focus is Anavex Life Sciences Corp (OTCMKTS:AVXL)

Anavex Life Sciences Corp (OTCMKTS:AVXL) is making an explosive move up on accelerating volume after reversing off $0.15 a share. The stock currently trades at a fraction of the $5 per share it commanded back in 2008.

After years of steep decline AVXL has come back to life in a big way; the CEO was recently at the 2015 AD/PD(TM) Conference where Anavex unveiled new promising preclinical data for both ANAVEX 2-73 and ANAVEX 3-71 in two separate presentations.

Anavex Life Sciences Corp (OTCMKTS:AVXL) is a publicly traded biopharmaceutical company dedicated to the development of novel drug candidates to treat central nervous system (CNS) diseases such as Alzheimer’s disease, pain and various types of cancer.

AVXL lead drug candidates, ANAVEX 2-73 and ANAVEX PLUS, a combination of ANAVEX 2-73 and donepezil (Aricept®), are currently being evaluated in a Phase 2a clinical trial for Alzheimer’s disease.

ANAVEX 3-71 is a unique and promising preclinical drug candidate with a novel mechanism of action shown to enhance neuroprotection and cognition in Alzheimer’s disease. It is a CNS-penetrable mono-therapy that bridges treatment of both cognitive impairments with disease modifications. ANAVEX 3-71 is highly effective in very small doses against the major Alzheimer’s hallmarks in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid and tau pathologies, and also has beneficial effects on inflammation and mitochondrial dysfunctions.

ANAVEX 2-73 is currently undergoing a Phase 2a trial in Alzheimer’s patients after completing a Phase 1 study with a clean data profile. In earlier preclinical studies, ANAVEX 2-73 showed potential to halt and/or reverse Alzheimer’s disease. Additionally, positive preclinical data reveals the potential for ANAVEX 2-73 as a platform drug to treat additional CNS disorders, including epilepsy.

On March 23 AVXL unveiled new promising preclinical data for both ANAVEX 2-73 and ANAVEX 3-71 (formerly AF710B) in two separate presentations at the 12th International Conference on Alzheimer’s and Parkinson’s Diseases and Related Neurological Disorders in Nice, France.

Further evidence was provided that ANAVEX 3-71 reduced soluble and insoluble Abeta1-40, Abeta1-42 and Abeta plaques in the 3xTg-AD animal model as well as decreased BACE1 expression.

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It was further demonstrated that ANAVEX 3-71 also decreased tau phospho-epitopes AT100, AT8 AT180, AT270, PHF-1 and decreased kinases inducing tau-hyperphosphorylation (p25/Cdk5 & GSK3beta) and mitigated cognitive impairments in the 3xTg-AD animal model. Cdk5 activator protein p25 preferentially binds and activates GSK3beta. Increased Cdk5/p25 expression has been demonstrated in the brains of patients with Alzheimer’s and Parkinson’s diseases and several other CNS diseases. Hence, ANAVEX 3-71 may restore synaptic homeostasis, by decreasing p25 and inhibiting GSK3beta & Cdk5.

It was further shown that ANAVEX 3-71 decreased the number of 6E10 positive Abeta1-42, activated astrocytes (GFAP) and microglia (Iba-1). The decrease in these inflammatory cell markers is likely a consequence of reduced Abeta in the brain, although any beneficial direct effect of the drug on inflammation might be possible.

It is believed that the effects of ANAVEX 3-71 are mediated by a concomitant activation of the M1 muscarinic receptor (M1R) and the S1R via an induced hypothetical heteromerization between M1R & S1R.

AVXL CEO Christopher U. Missling, PhD said “With the newly presented data we are very encouraged to have ANAVEX 2-73 currently in the clinic and are looking forward to provide an update on the progress of the trial next quarter. The new drug ANAVEX 3-71 indicates extensive therapeutic advantages in Alzheimer’s and other protein-aggregation-related diseases given its ability to enhance neuroprotection and cognition via sigma-1 receptor activation and M1 muscarinic allosteric modulation. We look forward to advancing ANAVEX 3-71 further into the clinic after the required GLP manufacturing and toxicology studies.”

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Currently trading at a $12.8 million market valuation AVXL does have $7 million in the treasury and is fully funded going forward. Now that the stock has made a significant reversal off $0.15 after years of steady decline and the Company is presenting promising preclinical data for both ANAVEX 2-73 and ANAVEX 3-71, Investors are giving AVXL another look. We will be updating on AVXL when more details emerge so make sure you are subscribed to Microcapdaily so you know what’s going on with AVXL.

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Disclosure: we hold no position in AVXL either long or short and we have not been compensated for this article.

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