Replies to post #257612 on Anavex Life Sciences Corp (AVXL)

[Turner2017]

What is your personal prediction on what the PDD news will be and what will the share price be like?

[makemydaze]

If 2-73 is capable of improving cellular function then perhaps the brain cells responsible for the production of dopamine can go back to being healthy and alleviate symptoms that way - just my hope however faint -

" One of the most common neurologic disorders that elders experience, Parkinson’s disease (PD) is a devastating diagnosis affecting approximately 2 of every 1,000 older adults. Although there is currently no cure and current PD treatments help alleviate only the symptoms rather than the disease’s progression, fresh hope lies in new research focused on neuroprotection.

PD, the causes of which are unknown, is a chronic, progressive brain disorder that belongs to a larger class of disorders called movement disorders. In PD, one particular population of brain cells—those that produce a chemical messenger called dopamine—become impaired and are lost over time. “The loss of these brain cells causes circuits in the brain to function abnormally, and those abnormal circuits result in movement problems,” says Beth-Anne Sieber, PhD, program director for the Neurodegeneration Cluster at the National Institute of Neurological Disorders and Stroke."

Seems like PD is difficult to even diagnose let alone treat -

"A PD diagnosis is usually guided by presenting symptoms because there is no blood or other test to diagnose the disease. Although one might think a brain scan such as an MRI may be successful in detecting PD, “in a scan like magnetic resonance imaging, which shows structural changes in the brain, they appear normal in Parkinson’s disease because these cells that die off are a very small population, yet they have a huge impact on the patient’s movement,” says Sieber.

Diagnosis can also be complicated by the fact that other disorders can have similar symptoms to those exhibited with PD. After older adults are put on PD treatments for their symptoms, a more definitive diagnosis can be made. “Parkinson’s disease may be difficult to diagnose initially, but the classic PD symptoms and response to medications are supportive factors,” says Sieber."

https://www.todaysgeriatricmedicine.com/news/ex_06309_03.shtml

[georgejjl]

I expect Anavex 2-73 will report positive results for each of the following:

Outcome Measures

Primary Outcome Measures :
Cognitive Drug Research (CDR) Computerized Assessment System Continuity of Attention [ Time Frame: 14 weeks ]
Change from Baseline to End of Treatment in Continuity of Attention as measured by Cognitive Drug Research (CDR) Computerized Assessment System Continuity of Attention test

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 14 weeks ]
Assess the safety and tolerability of ANAVEX2-73 compared to placebo


Secondary Outcome Measures :
MDS-UPDRS Part III Total Score (Motor Scores) [ Time Frame: 14 weeks ]
Change from baseline to End of Treatment as measured by MDS-UPDRS Part III Total Score (Motor Scores)

SDS-CL-25 [ Time Frame: 14 weeks ]
Incidence of sleep disorders symptoms (SDS-CL-25)

https://clinicaltrials.gov/ct2/show/NCT03774459

Good luck and GOD bless,

[kld2]

I sold 1/4 of my shares at 5.25 and sold some $5 strike July covered calls to lock in profits and take a smaller position through topline release

Ditto.

[blu_1]

I give the PDD phase 2 study about a 20% chance to have a p<0.05 and only a 5% chance for p < 0.01.

That's before applying precision medicine, or after?

[anders2211]

DOC I have a question you said:

I'm not expecting benefit of A273 for tremor in PD

Is this specifically only for PDD patients? because for the RETT patients in the trial Anavex dit report an improvement in motor skills

In addition to the significant improvements of the two global efficacy endpoints, the Rett Syndrome Behaviour Questionnaire (RSBQ) Total score and the Clinical Global Impression – Improvement (CGI-I), the RSBQ Hand Behaviours and the RSBQ Breathing Abnormalities improved during the trial.

Also because in a previous post you said:

A273 is an M1-M4 agonist and S1R agonist. In PD, there is a selective loss of dopaminergic neurons, especially in the substatia nigra (pars compacta). These neurons project to the basal ganglia. DA and M4 receptors co-localize in many neurons in the BG. DA is inhibitory and ACh )acting through M4) is excitatory. Tremor is caused by the imbalance of these input signals. Hence, M4 activation is unlikely to help tremor and actually may worsen the imbalance of the inhibitory / excitatory inputs to the BG

thanks for answering

[blu_1]

I'm not expecting benefit of A273 for tremor in PD.

Preclinical study indicated otherwise.

Dosing of ANAVEX 2-73 daily for five weeks in a 6-hydroxydopamine lesions mouse model of Parkinson’s disease was followed by a battery of standardized tests that are linked to parkinsonian motor symptoms. The data indicates that ANAVEX 2-73 is well tolerated, induces significant motor recovery (p<0.05), induces neurohistological restoration (p<0.05) and reduces microglial activation (p<0.05), a potential biomarker of Parkinson’s disease. Behavioral patterns were completely normal, meaning no signs of either dystonia or stereotypic behaviors were detected in animals receiving the treatment.

www.anavex.com/anavex-life-sciences-drug-shows-efficacy-to-support-potential-disease-modification-in-parkinsons-disease/