Mid-Dose Results30 Nov 2010 07:50
The following are my views on the latest trial results:
Take a look at the presentation at pages 12 and 13:
http://medgenics.com/downloads/Presentation_Medgenics%20ASN%202010%20.pdf
On page 12, you will see that the low dose results are as follows for the 6 patients in total:
- 4 patients (2/3rds) were within the target 10-12 range for between and 24 months.
- 1 patient crossed below the 10 threshold but was there or nearly there for 3 months, and with a big jump up from around 7.25
- 1 patient was a non-responder
On page 13, you will see that the mid dose results are very different, with 6 further patients in total:
- 1 patient (1/6th) is within the target 10-12 range, but has only been observed for 1 month; not known if still continuing in trial.
- 1 patient failed to reach the 10-12 range, in the 9's
- 1 patient overshot the 10-12 range for some of the time though not majorly (sub 11), but has not dropped below the 10 threshold in 5 months
- 3 patients have fallen below the 10-12 range for part of their 3-6 months being observed in EPODURE, but have not fallen majorly below (9+)
So in short, they have moved from:
4/6 patients maintaining the 10-12 range for 3+ months on the low dose, with 5/6 having respectable results, to
0/6 patients maintaining the 10-12 range for 3+ months on the mid dose, with 4/6 having respectable results.
There are a number of unknowns, such as how long the period outside of the 10-12 range was, etc.
Given the clear response, albeit not as good a response, my interpretation is as follows:
Either
1) It is harder to predict very accurate responses with multiple Biopumps; and/or
2) The duration of sustainability can be more varied over time with multiple Biopumps
This can likely be remedied by (a) further trials taking place and/or (b) the addition, substitution and removal of Biopumps where appropriate, which I know is the company's plan, though the more of these that are necessary, the less cost effective the treatment is.
In summary, I think that the Biopump results on the mid-dose are good, but they are not excellent like the low dose results were. Further work on multiple Biopumps is required - they do have the high dose tests to do next, once full US funds are raised.
Food for thought, would be interested in views.