A place where friends and family can come and get an update on Jim and Gloria. A place to share pictures, laughs, wisdom, prayers, gripes and probably a few tears, too.
Wednesday, March 18, 2009
GVHD?
Hi all:
Too sick to report in depth. Jim had endoscopy. They saw 3 areas where they biopsied that look like GVHD. They took biopsies. If it is, pray it doesn't turn to bad GVHD. GVHD of gut is the worse.
dor biopharma has received an SPA from the FDA to reach an endpoint of Intestinal GVHD treatment failures at eighty days post randomization vs the standard of care (high dose predisone) which is not even approved. The P value needed in this one phase 3 trial is .05. In the prior phase 3 study the company reached this endpoint with a P value of 0.005. with a smaller number of patients. In my mind this means the clinical risk is very low. The company now has the resources to get the drug approved.
The primary endpoint is the treatment failure rate at Study Day 80. This endpoint was successfully measured as a secondary endpoint (p-value = 0.005) in the previous Phase 3 study as a key measure of durability following a 50-day course of treatment with orBec® (i.e., 30 days following cessation of treatment).
Other data from the prior phase 3 trial.
orBec® did achieve statistical significance in other key secondary endpoints such as the proportion of patients free of GVHD at Day 50 (p-value 0.05) and Day 80 (p-value 0.005)
The median time to treatment failure through Day 80 (p-value 0.0226),
A 66% reduction in mortality among patients randomized to orBec® at 200 days post-transplant with only 5 patient (8%) deaths in the orBec® group compared to 16 patient (24%) deaths in the placebo group (p-value 0.0139).
At one year post randomization in the pivotal Phase 3 trial, 18 patients (29%) in the orBec® group and 28 patients (42%) in the placebo group died within one year of randomization (46% reduction in mortality, hazard ratio 0.54, 95% CI: 0.30, 0.99, p=0.04, stratified log-rank test).
1 comment:
dor biopharma has received an SPA from the FDA to reach an endpoint of Intestinal GVHD treatment failures at eighty days post randomization vs the standard of care (high dose predisone) which is not even approved. The P value needed in this one phase 3 trial is .05. In the prior phase 3 study the company reached this endpoint with a P value of 0.005. with a smaller number of patients. In my mind this means the clinical risk is very low. The company now has the resources to get the drug approved.
The primary endpoint is the treatment failure rate at Study Day 80. This endpoint was successfully measured as a secondary endpoint (p-value = 0.005) in the previous Phase 3 study as a key measure of durability following a 50-day course of treatment with orBec® (i.e., 30 days following cessation of treatment).
Other data from the prior phase 3 trial.
orBec® did achieve statistical significance in other key secondary endpoints such as the proportion of patients free of GVHD at Day 50 (p-value 0.05) and Day 80 (p-value 0.005)
The median time to treatment failure through Day 80 (p-value 0.0226),
A 66% reduction in mortality among patients randomized to orBec® at 200 days post-transplant with only 5 patient (8%) deaths in the orBec® group compared to 16 patient (24%) deaths in the placebo group (p-value 0.0139).
At one year post randomization in the pivotal Phase 3 trial, 18 patients (29%) in the orBec® group and 28 patients (42%) in the placebo group died within one year of randomization (46% reduction in mortality, hazard ratio 0.54, 95% CI: 0.30, 0.99, p=0.04, stratified log-rank test).
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