titled Michael J. Fox Foundation Co-Chairs Meeting with FDA to Define Regulatory Path for New Drugs to Treat Cognitive Decline.
This is an anticipated consequence to the new propose FDA Regulatory changes for Alzheimer's still under the comment period. I have seen one other blog post immediately following the FDA AD policy change proposal as to how this might also change the landscape for Parkinson's, Huntington's Disease and other neuro degenerative diseases.
The takeaways from the meeting were encouraging, say Eberling and Vincent.
"In the short term, we're hopeful for flexibility in diagnosing and measuring cognitive changes in clinical trials," says Vincent. "At the meeting, we learned that it seems the field will not need to settle on a single set of diagnostic criteria or a single outcome measure. This is good news for work being done in the here and now — we can be assured that progress can resume, despite the lack of a uniform measure of cognitive decline."
In particular, this is important news for MJFF's current partnership with drug giant Sanofi on AVE8112, a drug which was previously in development for Alzheimer's disease, and which has shown promise in pre-clinical models of cognition. AVE8112 is in Phase 1 clinical testing; results from this early safety study could come as soon as the end of 2013. With positive results, Sanofi and MJFF would hope to move forward with a Phase 2 study next year.
It would be nice to see some efforts from Prana management in light of a new approval landscape to push PBT434 further along in the clinical trial pipeline having announce about 8 months ago (Aug 29) that it had met all of it's milestones.
Does PBT434 have as much promise to improve cognition and motor improvement as SNY's AVE8112?
Leaving it an open question to the discussion board....