Soligenix Inc (SNGX)

[drbio45]

unfortunately the 2 questions some of us had regarding the data were not asked:

it is amazing that only 2 questions weren't asked


1. survival benefit was limited to mismatched patients (likely because these patients overall do worse and have a higher mortality rate)..but what about other endpoints? (i.e. would be nice to know that perfectly matched patients also saw a benefit of therapy)

the survival benefit was better on the mismatched but it would take a larger trial to prove that to statistical significance which is why it was a surprise that they had this tremendous benefit in such a small trial and why it wasn't the primary endpoint. It is also amazing not only that they had the suvival benefit but even the 50 day trend and 80 day statistical significance when you look at the fact that the sicker patients [non-myeloablative] and higher risk of relapse patients were in the orBec arm. As you know drugs have a tough time getting approved if you use subset analysis. I think if the company tries to go in and figure out if the patients who were not mismatched did as well in the other endpoints they would actually be ruining the fact that they made statistical significance in the secondary endpoints in the trial as a whole. The important endpoints were positive in the trial as a whole. Why try to disprove it using subsets?

2. is there a possibility of a negative interaction between prednisone and orbec when coadministered given the higher failure rate during the initial treatment phase? (this was tangentially mentioned as a "fluke" towards the end of the Q&A - i think the data as a whole, including the lack of interaction in phase 2 (actually there was a benefit to the prednisone-orbec arm during coadministration in the phase 2), greatly mitigate this concern but I still would have liked to hear the argument DOR would give regulators if this was brought up)

I believe the best answer is the fact that there was no interaction problem in the phase 2[orbec worked better in the first 10 days] and the fact that 3 people in the orbec arm actually were too sick and shouldn't have been admitted into the trial, are the best answers and especially the panel will realize this.

I have my own reasons to think neither of these issues will impede full approval, but this was now the second missed opportunity to try and get clarification on these points from 2 separate investigators in the trial..bit of a shame