I have questions for Doc, frroll, Investor, Bio and others.
Puttting aside the dosing question, I have questions about the placebo effect relative to identification and confirmation of genomic biomarkers. Can the placebo effect have different effects in patients that have different genetic variants? Can the genetic variants and gene expression of patients in this trial be used to detemine the effect of AVXL 2-73 versus the placebo effect? Can the placebo effect correspond with each patients different genetic profile?
See below where Missiling says “... the analysis platform described in this work opens the possibility of using big data-driven unbiased genome-wide patient selection marker identification early on in the drug development process...”. I am not sure what Missling means, but it seems to me that the analysis of the trial results will involve making comparisons between groups (actual drug group - placebo group) on the basis of the genetic profiles of patients in each group?
My questions may not be worded that well, but I think you may understand what I am seeking to know. I do think the placebo effect is a valid concern with the clinical trials that Anavex has conducted, but I am trying to determine if genetic profiles may be used to address the placebo concern.
My questions relate to comments to the peer-reviewed journal, Alzheimer's & Dementia: Translational Research & Clinical Interventions, entitled, “A precision medicine framework using Artificial Intelligence for the identification and confirmation of genomic biomarkers of response to an Alzheimer’s disease therapy: Analysis of the Blarcamesine (ANAVEX2-73) Phase 2a clinical study.“
"This study highlights the relevance of phenotypic and genotypic precision medicine analyses of Whole Exome Sequencing (WES) and gene expression (RNAseq) data in drug development and in particular the potential to identify patients’ genetic variants and gene expression changes that may predict increased chances of success of Alzheimer’s disease treatments,” said Dr. Harald Hampel, M.D., Ph.D., M.A., M.Sc., Founding President of the Alzheimer Precision Medicine Initiative (APMI)1 and lead author of the paper."
"...We believe that the analysis platform described in this work opens the possibility of using big data-driven unbiased genome-wide patient selection marker identification early on in the drug development process of CNS diseases, including Alzheimer’s disease, which is currently applied more routinely in the field of oncology,” said Christopher U. Missling"
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