Anavex Life Sciences Corp (AVXL)

[sokol]

Currently, there is no approved treatment to either cure, slow or stop the progression of AD. The AD approved drugs on the market only treat symptoms, if that. Further, AD may cause insomnia and other problems. This is from the ALZ website:

''While there is no cure, prevention or treatment to slow the progression of Alzheimer's disease, there are five prescription medications approved by the U.S. Food and Drug Administration (FDA) to treat its symptoms.''......

''Alzheimer's medications do not help everyone. Research shows these medications work in about 50 percent of the people who take them for up to approximately two years.''

''...Alzheimer's or dementia may change your sleep patterns. You may have difficulty sleeping, take daytime naps, and/or experience other shifts in your sleep pattern. Researchers are not sure why these sleep changes occur. There are non-drug treatments and medications that may help improve your sleep.''

All five approved AD drugs have possible side effects.

http://www.alz.org/i-have-alz/treatments-and-research.asp

''In a disease state where progression is invariable over time, a sustained or stable MMSE and ADCS-ADL score is considered a positive outcome.

“The demonstration of an extended period of both cognitive and functional stability out to 31 weeks in a patient population that would normally be expected to experience ongoing cognitive decline is an encouraging milestone in the development of ANAVEX 2-73. The 31-week data also validates the earlier observation of improvements on tasks within the Cogstate battery. The specificity and consistency of these benefits suggest that ANAVEX 2-73 can sustain activation of attentional and working memory functions with repeated dosing in Alzheimer’s disease,” said Associate Professor Stephen Macfarlane, FRANZCP, Head of Clinical Governance, Dementia Centre HammondCare, who is conducting the study. “Of noticeable interest was also HAM-D data showing beneficial effects of ANAVEX 2-73 on insomnia, agitation and anxiety at 31 weeks, which might suggest an additional important role of ANAVEX 2-73 for the amelioration of behavioral and psychological symptoms of dementia (BPSD).”''

http://www.anavex.com/?news=anavex-presents-31-week-efficacy-data-from-phase-2a-study-of-anavex-2-73-in-alzheimers-patients-at-aaic-2016

''...no statistically significant decline from baseline was reported, which is impressive. Detailed pre-planned analysis of the pharmacodynamic results is in progress, which is one of the key factors of relevance for regulatory agencies and which will also determine the optimal dose for future studies.”

http://www.anavex.com/?news=anavex-confirms-data-from-phase-2a-study-of-anavex-2-73-in-alzheimers-patients-presented-at-aaic-2016

''With an aging population and no new dementia drugs in over a decade, the need to find treatments that can slow or stop disease progression is greater than ever.”
Dr. Doug Brown, director of research at Alzheimer’s Society

Expectations for AVXL 2-73 were too high in July at the time of the last report on the clinical trial. Many of us were expecting a cure. Absent a cure, as you can see from the above, a treatment that can slow or stop the disease progression is a remarkable achievement. We need to study the next data report for clues that I believe may occur in October, and we also need to realize that efficacy depends on completion of a phase III study acceptable to the FDA.

See this article. FDA Wants to Relax Approval Process for Alzheimer's Drugs | Health News | US News

http://health.usnews.com/health-news/news/articles/2013/03/14/fda-wants-to-relax-approval-process-for-alzheimers-drugs

''THURSDAY, March 14 (HealthDay News) -- In an effort to quickly develop drugs that could prevent or slow Alzheimer's, the U.S. Food and Drug Administration said it plans to relax the approval process for experimental medications for the memory-robbing disease.

In a proposal published online in the March 14 issue of the New England Journal of Medicine, the FDA said clinical trials of people in the early stages of Alzheimer's would only need to show improvement in tests of thinking and memory. Among these patients, who are only starting to show subtle mental declines, improvements in daily functioning would not have to be seen, The New York Times reported.

The FDA's goal is to speed development of drugs to treat a disease that has no cure, so that the millions of aging baby boomers at risk for Alzheimer's might be able to prevent or slow the degenerative disease. The FDA is taking comments on the proposal, and will possibly make revisions, but the plan is going forward, agency officials said.

Drug companies would still be required to do post-marketing studies on any approved drugs, to confirm their benefits and safeguard against any potential harms from long-term use of these medications.''

In conclusion, the above is why I believe that the market has overreacted to the July reports. So far, there is no indication that AVXL 2-73 does not work at least to some extent. However, patience is needed to see if efficacy is established, and we all should temper our expectations. If AVXL 2-73 shows any degree of efficacy, the FDA should be willing to speed up its approval.