AZD103 Phasell Trial....In Perspective..
.........This ELND005 Phasell Trial has been running since Dec. 2007 ............. It has been fully enrolled since Oct./08. So many of the
Higher Dosing Arm Participants have already completed the Trial. Its been 97 weeks so far for a 78 week Trial..................
Should be a good 2/3 to 3/4 of participants have already finished Trial and are now in the Phasell AD251 Extension Trial on the new 250 mg BID Dose.
It's not like they lost 177 of the 353 enrolled by withdrawing the 2 high dosing Arms............ On the Contrary.
My back of the napkin numbers come out that 44-60 Participants will have been withdrawn when considering 2/3 to 3/4 of patients should be completers. Thats somewhere around 12.5%-16% of the Total 353 Patients Enrolled have been withdrawn. That leaves 117-133 patients that will count as High Dose Completers when Top Line Efficacy Data is gathered for comparison to Placebo.
Both High Dose Cohorts withdrawn late in the game............1000mg BID is about 420% higher than shown to be efficacious in Pre-clinicals and the 2000mg BID High Dose is approx. 835% higher than pre-clinical efficacy..................Isn't it protocol that if Serious AE's are above 5% that steps must be taken to reduce or eliminate the participants exposure? This may explain why they chose not to down size the high dose patients down to 250mgBID when looking at it from a Legal Angle.. It may also well be that dropping them (the high dose) would be less harmful on the Trial as a whole than to continue them @ 250mg BID and risk putting the Trial as a whole at More Risk if the High Dose AE's were to carry over to the 250mg BID Cohort. Don't want That..............
It's not over yet by any means .........when put into perspective this trial ,although shaken up badly, may yet prove to be Statistically Significant Efficacy wise anyways. It will still have the Patient Numbers to garner Pivotal Trial Status. Like Menghis Bairu the Chief medical officer at Elan said........."We continue to expect the ongoing study to provide important data to guide the next steps in the development of ELND005 for the potential treatment Alzheimer's disease."
GLTA............