Replies to post #161451 on Anavex Life Sciences Corp (AVXL)

[dia76ca]

Here is an outline of the study co-authored by Hampel and Woodcock et.al.

1. Introduction: precision pharmacology in the context of precision medicine
1.1. The road to precision pharmacology: role and contribution of time and space in systems biology for research & development programs
1.1.1. Role of time
1.1.2. Role of space
2. Homeostasis and pathway-based therapy
3. Current status of blood-based biomarkers – inflammatory and metabolomic – for preclinical Alzheimer’s disease
3.1. Inflammatory biomarkers
3.2. Metabolomic biomarkers
3.3. Biomarker perspectives
3.3.1. Biomarkers as diagnostics
3.3.2. Biomarkers as guides to therapeutics
4. Cns inflammation in Alzheimer’s disease stages biomarkers and therapeutic targets
5. Anti-amyloid beta and anti-tau therapeutic strategies
6. Rethinking and optimizing the design of clinical trials from the precision medicine perspective
6.1. The right drug
6.2. The right dose
6.3. The right patient
6.4. Conduct of precision medicine trials for Alzheimer’s disease
7. How can drug discovery programs in Alzheimer’s disease accomplish a good level of translational quality to reduce the rate of failures?
7.1. Drug discovery translational for Alzheimer’s disease therapeutics
7.2. Inadequate drug discovery process
7.3. Inadequate target engagement to test the therapeutic hypothesis
7.4. Therapeutic hypothesis is changed to accommodate the compound properties
7.5. What can we do better?
8. Perspectives
Contributors to the Alzheimer precision medicine initiative – working group (APMI–WG)


I notice Abbvie is part of this consortium. I wonder if they might be a potential partner?

[tradeherpete]

Thanks av66,

Attempt #2 at transcribing Dr. Hampels speach;

The exciting part after the P2a trial and the extension trial where, I think it’s very important to know that we did whole genome sequencing of the patients who were involved in the P2a trial extension. And we found that there is a gene variant of the sigma one receptor gene. That is actually seen in 20% of patients. And these patients with this gene variant show a less favorable response than people with the Wild type. So people with the Wild type S1R gene have an improved response to the drug. That has been established as an exploratory outcome within the P2a study.

So in the upcoming large scale P2b/3 study, in 450 patients with early AD, we are planning to look at 2 aspects again, stratification regarding the genomics of the patients. We look at Wild types of the S1R gene carriers vs variant receptor carriers. And we expect a differential response depending on the genetic background. So using a genetic biomarker in studies like a one step forward to a Precision Medicine approach, in neuroscience there has already been successfully established in the field of Oncology with various drugs and cancers.

So I think this is a crucial step forward to improve the potential of a drug to get to it’s intended target and to reach the right patients at the right time. This is why we are doing it to promote also this Precision Medicine approach. This is why the Alzheimer’s Precision Medicine Initiative and Anavex are collaborating on this project.