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Saturday, 08/04/2018 10:00:46 AM

Saturday, August 04, 2018 10:00:46 AM

Post# of 469747
Attempt at transcribing Dr. Hampels speech;

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 in involved, 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 Physician Medicine Industry and Anavex is collaborating on this project.
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