Eoganacht wrote: There's nothing really new here. I'm just obsessing over the numbers while we wait. The table below is from the MD&A from the end of August. I have added the number of patients beside the percentages and included the "
No Response" patients. This table includes the 3 full dose patients from phase 1
(2 CRs and 1 NR) Out of 24 patients evaluated at 450 days there were
21% CR and
13% PR for a
Total Response rate of 33% | Assessment Days | 90 Days | 180 Days | 270 Days | 360 Days | 450 Days |
| | % | # of patients | % | # of patients | % | # of patients | % | # of patients | % | # of patients |
| Complete Response | 50% | 19 | 47% | 16 | 41% | 13 | 35% | 9 | 21% | 5 |
| Partial Response | 16% | 6 | 26% | 9 | 22% | 7 | 12% | 3 | 13% | 3 |
| Total Response | 66% | 25 | 74% | 25 | 63% | 20 | 46% | 12 | 33% | 8 |
| No Response | 34% | 13 | 26% | 9 | 37% | 12 | 54% | 14 | 67% | 16 |
| Evaluable Patients | 38 | 34 | 32 | 26 | 24 |
If we remove the 3 phase 1 patients from the table (2 CRs and 1 NR) we have the results for 21 patients evaluated at 450 days. Of these there were
14% CR and
14% PR and a
Total Response rate of 29% | Assessment Days | 90 Days | 180 Days | 270 Days | 360 Days | 450 Days |
| | % | # of patients | % | # of patients | % | # of patients | % | # of patients | % | # of patients |
| Complete Response | 49% | 17 | 45% | 14 | 38% | 11 | 30% | 7 | 14% | 3 |
| Partial Response | 17% | 6 | 29% | 9 | 24% | 7 | 13% | 3 | 14% | 3 |
| Total Response | 66% | 23 | 74% | 23 | 62% | 18 | 43% | 10 | 29% | 6 |
| No Response | 34% | 12 | 26% | 8 | 38% | 11 | 57% | 13 | 71% | 15 |
| Evaluable Patients | 35 | 31 | 29 | 23 | 21 |
The data submission to the FDA of
450 day results for the first 25 phase 2 patients will incude the results of 4 more patients. The best case scenario would be if all 4 were CR. This would be a 450 day
CR rate of 28% and a
total response rate of 40%.
| Assessment Days | 450 Days |
| | % | # of patients |
| Complete Response | 28% | 7 |
| Partial Response | 12% | 3 |
| Total Response | 40% | 10 |
| No Response | 60% | 15 |
| Evaluable Patients | 25 |
But there's really no reason not to include the 3 full dose patients from the phase 1 trial. Theralase will be submitting complete 450 day data on
28 evaluated patients. The best case scenario for the 28 is a 450 day
CR rate of 32% and a
total response rate of 43%. It should also be kept in mind that this submission represents 450 day results for only
25% of the patients who will be treated in this trial, and half of that 25% was undertreated. The results of the (at least) 75 patients yet to reach 450 days should significantly improve the numbers. There is also the possibility that the 3 NR patients will be reclassified CR which would mean a possible
450 day CR rate of 40% for the 25 patients and 43% for the 28 patients. | Assessment Days | 450 Days |
| | % | # of patients |
| Complete Response | 32% | 9 |
| Partial Response | 11% | 3 |
| Total Response | 43% | 12 |
| No Response | 57% | 16 |
| Evaluable Patients | 28 |