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Saturday, November 26, 2022

Coming Back Strong: Anavex Life Sciences Corp.(NASDAQ:AVXL)

Anavex Life Sciences Corp.(NASDAQ:AVXL) is coming back strong after the Company announced positive primary and secondary endpoints were achieved in a phase 2a clinical trial of ANAVEX 2-73 in Alzheimer’s Disease. The news comes on the heels of several days that AVXL Investors would love to forget as the stock sunk heavily since hitting a high of $14.83 last week.

MicroCapDaily has been reporting on AVXL spectacular rise since Anavex moved north off its $0.15 base back in March of this year saying at the time ”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.”

Anavex Life Sciences Corp.(NASDAQ: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. According to earlier reports ”is sitting on drugs in development that could potentially turn the multi-billion dollar Alzheimer’s market upside down.”

As Anavex has risen in recent months the shorts have become much more aggressive citing the irrelevant fact that AVXL started off as a photo finishing Company when it was a shell. The long position cites the fact that trial participants and their caregivers requested that they be allowed to continue taking the drug even after part 2b and that Dr. McFarlane, from the Alzheimer’s field, who is conducting the clinical trial says this is the most exciting thing he is ever been involved in. And that at least one of the trial participants said that taking Anavex 2-73 was like fumbling around in the dark and then somebody turns the light on.

According to fool.com ”Americans are spending $226 billion annually to treat the symptoms of Alzheimer’s disease, and other dementias, rather than the cause of this disease itself. That’s an endlessly frustrating revelation that if left unchecked, could pose a big threat to the healthcare system. According to the Alzheimer’s Association, Alzheimer’s disease could cost Americans $1.1 trillion — yes, trillion — by 2050.

So there is no cure for Alzheimer’s disease, just 4 FDA approved drugs perscribed and sold on the market to treat the symptoms, not the cause.

What makes Anavex such an exciting story is the Company is not focused on treating the symptoms of Alzheimer’s but rather is focused on the root cause which is believed to be protein misfolding. AVXL’s Anavex 2-73 can work as an agonist for the sig-1R receptor that is behind protein misfolding. What is even more exciting is the fact that the same mechanism can work in Parkinson’s and Huntington diseases.

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 and continue to be the major catalyst here.

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.

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Anavex began life as Thrifty Printing, a digital to photo print business targeting corner stores that didn’t work out. In 2007 the Company announced it has acquired a portfolio of three patents and one patent application covering drug candidates intended to be further developed through commercialization targeting the areas of neurological diseases and cancer. The patents were assigned by Dr. Alexandre Vamvakides who became CEO of the Company.

The Anavex story really took off when Dr Christopher Missling took over as CEO; he quickly assembled a team of big pharma and biotech experts, doubled the number of Scientific Advisors which is mostly Medical Doctors and raised a company’s record amount of $10M in one funding transaction which means that AVXL is now fully funded going forward.

On November 9 AVXL said investigators presented positive safety and cognitive efficacy data for ANAVEX 2-73, the Company’s lead investigational oral treatment for Alzheimer’s disease targeting sigma-1 and muscarinic receptors, which are believed to reduce protein misfolding including reduction of beta amyloid, tau protein and inflammation at the international CTAD 2015 conference in Barcelona, Spain.

Initial analysis of Phase 2a data demonstrated that the study met the primary objective of safety as ANAVEX 2-73 was well tolerated and results were consistent with prior Phase 1 clinical trial data.  The secondary objectives were also met, with ANAVEX 2-73 showing cognitive improvement across all doses in all exploratory cognitive measurements, including the Cogstate battery, Mini Mental State Examination (MMSE), event-related potentials (ERP) and P300 tests, which consistently demonstrated improvements from baseline in the completed PART A portion of the study in 32 mild-to-moderate Alzheimer’s patients.

Positive effects on cognition were further supported by highly statistically significant biomarker effects of treatment at week 5 on one event-related potential (ERP) measure with a p-value of p<0.0007 and improvement in the P300 signal.  The ERP biomarker scores improved compared to the initial data presented at AAIC in Washington, DC in July 2015, by which time not all patients had yet completed PART A.

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AVXL has $7 million in the treasury and is fully funded going forward with Phase 2a. This is one stock that has got everyone’s attention; the Company is sitting on drugs in development that could potentially turn the multi-billion dollar Alzheimer’s market upside down and the Stock is up big as the Company was up-listed to the NASDAQ stock exchange. And its not just Alzheimer’s, Anavex 2-73 could work for Parkinson’s and Huntington diseases as well. The big date here is November 7 when AVXL will present full PART A and preliminary PART B Phase 2a clinical trial data at the CTAD conference. The science behind Anavex is compelling the implications of which could be enormous from current price levels. 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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2 COMMENTS

  1. I find it funny that detractors use the term “placebo effect” when describing 2-73’s success in a 5 week trial for efficacy.

    These are people who can’t remember what happened yesterday, let alone maintain enthusiasm for one of many medications they take for their AD. And if they can retain excitement for being in the study, that just might be the drug working.

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