Anavex Life Sciences Corp (AVXL)

[F1ash]

“This observed heterogeneity is also seen in other therapeutic areas such as oncology. In oncology, multiple small, open-label clinical trials are run in which a broad range of biomarker candidates are identified and hypotheses generated and tested iteratively, serving as foundation for the design of follow-up controlled studies. Crizotinib is a good example of accelerated approval in oncology following an open-label Phase 1a study, where a novel biomarker (ALK+) was first identified based on 2 of 11 patients with non-small cell lung cancer enrolled in a Phase 1 dose escalation trial.54 The biomarker was validated through an amended Phase 2a study including 19 patients, with 10 out of 19 patients being labeled as responders, which ultimately led to a preliminary drug registration. Subsequently, a confirmatory trial enrolled 82 ALK+ patients and showed 57% partial response and 1% complete response. “






That is probably the basis for the job description Anavex posted which included a preference for oncology experience.





So it seems to me the plan is to look at the small number of improved patients that should predictably show up in the current AD trial and see if they share some common markers that enhance response and then run a confirmatory trial with those parameters.







https://alz-journals.onlinelibrary.wiley.com/doi/full/10.1002/trc2.12013