Anavex Life Sciences Corp (AVXL)

[Investor2014]

Not sure there is a fine line between Selection Bias and Precision Medicine.

For example in general folks on Donepezil or Memantine are unlikely to be of some phenotype specific to them. Whereas, in Precision Medicine the selection criteria, like in many cancer trials, tends to be a very specific genetic biomarker of tumours necessary for the drug under test to work optimally.

Anavex are yet to run any such biomarker specific Precision Medicine trial enrolling only the patient with a match.

So far I would call what Anavex have done Precision Research in the pursuit of Surrogate Endpoint biomarkers. Early on Anavex thought the SIGMAR1 and COMT1 wildtype genes could be it, but as it happens neither has strong enough outcome differences to act as a surrogate endpoint. SIGMAR1 mRNA expression instead has become a good indicator of A2-73 interacting with ONE of its MoA targets.

True Precision Medicine selection criteria are likely to have significantly more influence on outcomes than 'simple' selection bias.

I believe the recent full exome genetic pathways analysis of Parkinson's / Alzheimer's identification and and influences of A2-73 on it, may combined with analysis of the AD P2b/3 data, yield useful Precision Medicine patient selection criteria.