Soligenix Inc (SNGX)

[jshaffer85]

Two effects, two indications

1) The underlying problem with the data is the unknown effect of the 10 day run-in period when orbec is given with the SOC. The Phase II results showed improved efficacy, in the Phase III there were twice as many failures in the orbec arm.

2) On the question of whether orbec can enhance remission of GVHD w/o the use of systemic steroids, the evidence is clear. In the Ph II trial, all 16 responders to prednisone induction remained in remision at the point the orbec was cut off 20 days later (compared to 25% of placebo that had reocurrence of GVHD). In the Ph III trial the 50 day primary endpoint becomes extremely robust when only those in remission by day 10 are analyzed.

As suggested by hbnathans at YMB:
Thus, one solution for Pazdur could be to allow orbec approval for maintaining control of GVHD once the SOC has brought it under control. To answer the question of concurrent use of orbec with the SOC to bring initial GVHD under control, a large placebo controlled trial could be administered and if properly stratified should give a final answer to #1. Trial participants in the placebo arm that are responders would of course be eligible to start orbec upon prednisone taper.

Sorting out these two effects would go a long way towards completing orbec's efficacy characterization.