Anavex Life Sciences Corp (AVXL)

[polarbear77]

Fact: the company continues to use unambiguous language stating that its compound “restores cellular homeostasis” and provides “dose dependent cognitive improvement”. [Comment: understandably they’ve a safe harbor disclosure in p/r’s and presentations however realistically speaking, would they continue to make these scientific assertions without substantial and sufficient data to back them up?]

Fact: the Ariana data analytics firm has many of the largest BP companies as its clients, and Ariana recently indicated approximately 20 times in their pk/pd presentation on our AD ph 2a trial extension results through 57 weeks that they found a clear and strong dose dependent and blood concentration level efficacy response & correlation with a2-73 in our AD participants.

Fact: Anavex & Ariana presented recently that a majority of our >4 ng/mL blood concentration Alzheimer’s Disease participants IMPROVED/STABILIZED over 57-109 weeks (reference slides 23, 24 ctad)

Fact: Our phase 2a efficacy results (and the real world comments and perspectives provided by our participants’ caregivers) were after 57-109 weeks of NON-OPTIMIZED DOSING.

Fact: Dr Gottlieb, FDA Commissioner spoke on 9/11/17 and indicated: “Our goal is to see how we can accelerate methods that improve our ability to use advanced tools to meet FDA’s gold standard for regulation. These methods are being applied to both common and rare diseases. FDA is also collaborating with scientists to use similar computational tools to develop natural history models, based on placebo arms in Parkinson’s disease, Huntington’s disease, Alzheimer’s disease, and muscular dystrophy. If we’re able to make better use of rigorous, reliable natural history models, especially for rare diseases, it can help make clinical trial recruitment more efficient.” AND “We’re also advancing the use of ‘Master Protocols’ to enable more coordinated ways to use the same trial structure to evaluate treatments in more than one subtype of a disease or type of patient.”
https://www.fda.gov/NewsEvents/Speeches/ucm575400.htm

Fact: our AD trial PI, Dr Macfarlane, and Anavex have previously stated that 8 out of 8 of our AD trial participants that started with insomnia/sleep disturbances were without said symptoms at the end of one of our phase 2a extension dates. [prior NIH published studies and Dr George Perry have discussed the links between sleep and restoring cellular homeostasis and reduction of oxidative stress. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3921176/#!po=1.60550

https://therivardreport.com/utsa-pursues-progress-against-alzheimers-cancer-and-biological-warfare/ ]

Fact: Dr George Perry has been quoted as saying about our a2-73 ph2a extension results: “Although this is an open label study with 32 patients, I have never seen mild-to-moderate Alzheimer’s patients maintain near baseline cognitive and activities of daily living function and positive correlation with all other measures over a 41-week trial period in any prior study with an approved or experimental drug. It is quite plausible that complex CNS diseases like Alzheimer’s may require a comprehensive approach, including restoration of cellular homeostasis.”

Fact: Dr Missling reiterated in October 2017 that they’ve enough cash for another 2 years.

Fact: in the June 2017 Jefferies presentation, Dr Missling indicated several times “significant” cognitive improvements (around the 9:00 - 11:00 minute marks) and he continually indicated that the results were “dose dependent” and were all “correlated” across the different cognition tests. Further in same presentation Dr M reminded that the compound has broad applicability across the CNS disease spectrum.

Fact: upon hiring the 24 year FDA veteran, Dr Fadiran, as SVP of Regulatory Affairs, the p/r stated on 5/1/17: “His depth of experience makes him an excellent choice to manage the considerable number of regulatory filings that Anavex has planned.”

Fact: in late July 2017 upon the addition of our newest SAB member, Dr Andrew Cole said, “I look forward to advising the company as it’s about to initiate three clinical trials with significant unmet needs.”

Fact: all of our Alzheimer’s Disease phase 2a trial participants CHOSE to stay on a2-73 for two additional trial extension periods at their and their caregivers’ discretion.

Fact: per slide 26 of the June 2017 Jefferies presentation, a2-73 shows restoration of P300 amplitude to healthy adult levels through week 53.

Fact: Company has reiterated over the past 12 months that a2-73 shows effects of penetrating the blood brain barrier as the mild side effects (headache/dizziness) are occurring at the 50mg (high) dosage levels.

Fact: the positive effects of Sigma-1 receptor agonists have been the subject of over 106 previously-published scientific peer-reviewed papers (credit sliceanddice) and “a2-73 has seen specific preclinical validation in 10 different neurodegenerative diseases” (credit Nobrainerstocks sticky post).

Fact: the Parkinson’s Disease preclinical research (continuing for at least 3 years) presented & conducted by Dr Veronica Francardo (3rd party independent researcher associated with the MJF Foundation grant) showed a2-73 induced neurorestoration and (as per her earlier conclusion): “Our results reveal that ANA 2-73 ameliorates motor deficits in tests assessing spontaneous rotational activity and forelimb use asymmetry, and exerts noticeable neurorestorative effects on the damaged nigrostriatal dopamine system.”

Fact: Dr Robert Lisak from Wayne State University’s highly respected and independent Multiple Sclerosis lab presented preclinical results on 10/27/17: “A unique feature of ANAVEX2-73, compared to another sigma-1 receptor agonist we studied, is that ANAVEX2-73 accelerates the maturation of oligodendrocyte precursor cells (OPC) to oligodendrocytes (OL)” said Dr Robert P. Lisak. “This is an important feature since OPCs can replace lost OLs by maturing into new potential myelin-producing cells. In other words, ANAVEX2-73 might promote remyelination. Further data also demonstrates that ANAVEX2-73 provides protection for OL, OPC’s, as well as central nervous system neurons in addition to helping repair by increasing OPC proliferation and maturation in tissue culture.“

Fact: Anavex has previously published various preclinical positive efficacy results regarding a2-73 seizure reduction (which has potential applicability to numerous diseases such as Rett Syndrome, Epilepsy, Angelman, Fragile-X, infantile spasms, others). Dr Missling has previous stated: “a2-73 shows a very nice dose dependent reduction in seizures in so far 4 models.”


Disclaimer: above is simply my non-scientific understanding of the current set of facts related to my own PERSONAL investment thesis; not intended as investment advice in any way shape or form. All must do their own DD and only invest what is affordable to lose. GLTAL

Additional links below:

http://www.anavex.com/anavex-life-sciences-reports-new-data-anavex-2-73-neurodevelopmental-disorders-including-angelman-syndrome---data-presented-antiepileptic-drug-trials-xiv-2017-conference--/

http://www.anavex.com/anavex-announces-u-s-fda-orphan-drug-designation-for-anavex-2-73-for-treatment-of-infantile-spasms/

http://www.anavex.com/anavex-announces-positive-preclinical-results-with-anavex-2-73-in-fragile-x-autism-related-disorders/

http://www.anavex.com/anavex-presents-preclinical-results-of-anavex-2-73-in-rett-syndrome/