re: Ann: Prana announces preliminary results ...
Hi maslow, (I welcome your thoughts to the below) I took a huge hit today as other longs who have not taken anything off the table. However, after the initial shock, I still believe that Pbt2 is an active (and disease modifying) drug which does its job and reduces the rate of decline in the Ad and HD patient. My reasons are as follows:
1.In the first AD trial we saw a Statistically Significant improvement in Executive Function (EF) and a statistically significant Dose Response. 2.In the first AD trial we saw the reduction in A-Beta42 in the CSF 3.In the HD trial we again hit Statistical Significance in EF. 4.In the HD trial we saw a trend in brain atrophy as we also saw this in the IMAGIN trial. 5.Below is a post that was made by a poster from another message board regarding Total Functional Capacity where the TFC of the placebo group matched a 575 patient study and the 250mg drug group was about half the expected decline. (see below for the posters write-up) The above did not happen by chance IMHO. My take is that the drug (Pbt2) is engaging the target and IS having a Disease Modifying effect. There are no other drugs that come even close to these results. I believe Pbt2 will eventually be approved for both diseases (AD and HD). The road for AD may be a little longer.
TFC...let's dig deeper! Total Functional Capacity (TFC) Scale details level of function in the domains of workplace, finances, domestic chores, activities of daily living and requirements for unskilled or skilled care...
In a study published in Neurology [2000 Jan 25;54(2):452-8], the annual rate of decline for 575 patients with baseline TFC scores of 7 to 13 was 0.97…
the mean baseline score across all three groups in the phase II HD trial was around 9…thus, they fall in the range of the aforementioned study published in Neurology....
the HD trial was 34 weeks, thus, you would then assume a decline of about .63 on the TFC…I did this by just taking the expected .97 drop that would be expected in a year, and prorated it by the 34 week trial duration...
WHAT DID WE SEE in our HD trial….250mg PBT2 = -0.3; 100mg PBT2 = -0.5; placebo= -0.6….
WE SEE THE decline in the placebo group being about exactly what we would expect [-.6 versus -.63]…
BUT…and here in lies the beauty…we see the decline about half that in the 250mg group [-.3]…when this is properly powered in phase III we should have statistical significance on this very important dependent variable…
PBT Price at posting:
$1.04 Sentiment: LT Buy Disclosure: Held
