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A Major Breakout On Anavex Life Sciences Corp (NASDAQ:AVXL)

A Major Breakout On Anavex Life Sciences Corp (NASDAQ:AVXL)
Written by
Alex Carlson
Published on
July 1, 2016
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After consolidating between $4 and $4.75 per share for over a month, we're finally getting the breakout we were looking for on Anavex Life Sciences Corp (NASDAQ:AVXL). We've been pounding the table on AVXL for quite some time and told our readers and subscribers that Anavex will continue to defy the bears. There is perhaps no other biotech trading that has more haters than Anavex. When you objectively look at Anavex and see that the science behind the company is real, it astonishes us that there seems to be more rooting for its failure than its success.Anavex’s lead drug candidate, ANAVEX 2-73, is currently in a Phase 2a clinical trial for Alzheimer’s disease. ANAVEX 2-73 is an orally available drug candidate that targets sigma-1 and muscarinic receptors and successfully completed Phase 1 with a clean safety profile. 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 (MJFF) 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 key to understanding Alzheimer's is that ANAVEX 2-73 is based on oxidation and nitration causing Alzheimer’s. Other drug companies have instead focused on the cause being amyloid. They have misdiagnosed the cause while we believe Anavex has the correct approach. When you consider that Alzheimer's treatment costs over $200 billion a year in the United States alone, ANAVEX 2-73 has the potential to become not only a blockbuster, but one of the biggest selling drugs in history.In late 2014, Anavex began a 32-patient trial in Australia to determine a maximum tolerated dose for 2-73 in patients with mild to moderate Alzheimer's disease over 36 days. The trial also included testing their cognitive abilities at defined interims up to 52 weeks. In March, Anavex announced that it received the approval from the Ethics Committee in Australia to extend the ongoing Phase 2a Alzheimer’s trial, which had been requested by patients and their caregivers. The trial extension is designed to allow participants who complete 52 weeks in PART B to roll-over into a new trial and continue taking ANAVEX 2-73 for an additional 104 weeks, providing an opportunity to gather extended safety and efficacy data. The trial is independent of the company’s planned larger Phase 2/3 double-blinded, placebo-controlled study of ANAVEX 2-73 in Alzheimer’s disease.There was a lot of buzz about Anavex when the media in Australia started reporting that "PATIENTS have woken up from some of the most devastating impacts of Alzheimer’s disease, regaining the ability to play sport, paint and enjoy time with family, after a world-first drug trial in Melbourne. The remarkable results have fuelled hopes among doctors of the first major improvement in treating the horror disease since the 1990s. Pianist Pauline Stevens has regained the ability to play the piano after being placed on the experimental Anavex 2-73 drug trial at Caulfield Hospital." The story further added:

While the turnaround in the abilities and mood of the 32 patients involved has been the most overwhelming factor, the early data has been equally impressive. It shows a huge improvement in the cognitive ability of the patients, with the drug so far proving to be four-times more effective than the current treatment. The drug is designed to ­target the sigma-1 receptor cells that remove abnormal proteins from cells, but which can stop functioning effectively as people age. By rebooting the process, the drug is hoped to clear the build-up of troublesome proteins believed responsible for neurodegenerative conditions. Protocols for a much larger controlled trial to begin early next year are now being drawn up as the full results of the trial led by the Caulfield Hospital, but also involving patients from the Austin, Royal Melbourne and St Vincent’s hospitals, are finalised.

Currently trading with a market cap of $218 million, AVXL is one of the most exciting biotech stories today. We're expecting an update from the company on a larger Phase 2/3 double-blinded, placebo-controlled study of ANAVEX 2-73 in Alzheimer’s disease soon. This will really get the stock heading even higher once this is announced. We will be updating Insider Financial as soon as we know more. For continuing coverage on AVXL, sign up for our free newsletter and get a free ebook as an added bonus!Disclosure: We have no position in AVXL and have not been compensated for this article.

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