RE: NEWS!!AZD103 to get P2 for another Indication
Not only is AZD-103 getting a second Phasell started soon but.....
.....CEO Kelly Martin is also quoted as saying that AZD-103 could catch up with their other AD Drug AAB001. Wonder how when it's SO Ahead?? Think SubpartE Filing in the USA. This is where Fast Track status kicks in. AZD-103 can be approved by the FDA under SubPart E with Phasell Data.
Approval could also be based on Surrogate Endpoints under SubPartE the FDA can grant marketing Approval based on surrogate endpoints that appear "reasonably likely" to predict clinical benefit with actual clinical benefit being confirmed After Approval. Once again a Fast Track Benefit and option!
Kelly Martin is becoming known for his spot on predictive remarks. He can't come right out and say quite a few things.........but for those listening we are seeing these things coming true time after time. Take Phaselll ongoing when Phasell isn't even finished for example. So when he says ....."AZD-103 could catch up with AAB001 in Clinical Trials"..... we sit up and take note.
Elan CEO Kelly Martin said at the JP Morgan that ELND005/AZD-103 will be getting a second Phasell Trial started targeting another Indication "Early Alzheimers"......perhaps starting H2 of this year 2008 .......Don't believe Him??? Too Bad!!
Can't help but think that all the Amyloid Oligomer work done by Selkoe , Walsh. Shankar. Townsend etc. went into this decision. CLEARY too with the Lever Pressing Task showing a reversal of symptoms in LTP (Long Term Potentiation). SHANKAR et al 2007 showed that Scyllo-Inositol Reversed Synaptic Failure associated with the Toxicity that the Beta-Amyloid Oligomers, specifically Dimers and Trimers have on the synapse and associated Dendritic Spine Loss.
They also showed that the Monomers had no such effect and just go about their business. It is when they are folded into Oligomers that the toxic effects arise!! This is related to very very early Alzheimers before any plaques OR Tangles are seen......when the memory starts to go! They're saying a good 7 years before any Amyloid Plaques would even be visible!!
I wonder if MCI will be the target as well or just Early Alzheimers .....or Both. Doesn't matter really though. Physicians could prescribe AZD-103 Off-Label for MCI if approved for "Early Alzheimers"
Hmmmmmmmm.......
Interesting to NOTE: It's believed that the MCI market is 4 or 5 times LARGER than the Alzheimers Market. 5 million in the States alone have Alzheimers so MCI is estimated at 25 Million sufferers.........That is HUGE!!
Yup....