The last few week have been rough for shareholders of Anavex Life Sciences Corp (NASDAQ:AVXL). The market has been more focused on the drama over on Seeking Alpha and the recent raft of lawsuits filed by ambulance chasing lawyers. These events have overshadowed the recent positive dose-response data for ANAVEX 2-73 in Alzheimer's patients and the company's outlook for 2016. There's a lot going to be happening this year and it's time to focus on where things are heading with ANVX.First up is the positive dose-response data that has been observed in a pre-planned interim analysis of data from the ongoing Phase 2a trial of ANAVEX 2-73 for treatment of mild to moderate Alzheimer’s disease. The change in Mini Mental State Examination score (MMSE-Δ) (MMSE difference recorded for every single study subject at the beginning and the end of the five week period) from baseline to 5 weeks as a function of ANAVEX 2-73 dose was examined using linear regression analysis. Among 32 patients treated with doses of ANAVEX 2-73 ranging from 3mg to 50mg/day, the MMSE-Δ data showed a positive slope with confidence intervals not including the zero-value, consistent with a dose dependent improvement in MMSE scores over 5 weeks. The effect was unidirectional and also positive on another pharmacodynamic readout, the ERP-Δ P300 amplitude.The dose-response results were robust to statistical resampling (bootstrap analysis x 10,000 resamples). Analysis of variance and post hoc tests as well as Bayesian hierarchal analysis further confirmed that the higher doses achieved a statistical significant improvement in the MMSE-Δ score over 5 weeks compared to the lower doses. Based on these findings, it was estimated that an oral dose of 30 mg ANAVEX 2-73 had approximately 80% probability of achieving a +2 points or higher improvement in MMSE score over 5 weeks of treatment. Doses in this range have thus far been well tolerated by the study’s subjects, with no adverse events reported above grade one.As I have said before, the way to defeat the shorts and the ANVX bashers is for the company to deliver positive results and focus on the science. That is what CEO Dr. Christopher Missling is doing. On February 8th and 9th, he will be presenting at 18th Annual BIO CEO & Investor Conference at the Waldorf-Astoria Hotel in New York. This will give him the opportunity to present the latest on ANAVEX 2-73 to leading pharma executives and investors. Big things are not only possible, but highly likely to come out of this event for ANVX.
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We are also seeing a political push for more money towards finding a cure for Alzheimer's. In early December, an increase of nearly 60 percent for Alzheimer’s research was passed by the U.S. Congress in the federal spending bill, expanding funding from $586 million in 2015 to $936 million in 2016. In the UK, the Dementia Discovery Fund was just created. The fund is a new $100 million global fund to assist small biotechs and entrepreneurial ventures in finding a treatment or cure for Alzheimer’s. The fund is sponsored by the British government, the charity Alzheimer’s Research UK, Johnson and Johnson, Eli Lilly & Co., Pfizer, Biogen Idec and GSK.This type of funding is desperately needed. For every $27,000 Medicare and Medicaid spends on caring for individuals with Alzheimer’s, the NIH spends only $100 on Alzheimer’s research. Furthermore, Medicare’s annual expenditures are projected to triple from $300 billion currently to $1.5 trillion by 2050 if no cure for Alzheimer’s is found. The reality is that Alzheimer's has the potential to bankrupt Medicare if a cure is not found.
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The reality with early stage biotechs like AVXL is that investors need to be patient. Wait for positive news and watch the shorts cover. Anavex is doing what it's supposed to do. In the past year, the company has strengthened its balance sheet, maintained its NASDAQ listing, and invested in R&D. Management is doing what a good management team is supposed to do. There will be plenty more to come on AVXL. Make sure you are signed up to Insider Financial to get the latest updates on AVXL!
Disclosure: We have no position in AVXL either long or short. We have not been compensated for this article.
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