GC4419 Cisplatin q3wk and qwk arms beat placebo an
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Posted On: 03/02/2019 4:56:01 PM
GC4419 Cisplatin q3wk and qwk arms beat placebo and other competing drugs (Clonidine Lauriad, Palifermin, and SGX942) by a substantial margin.
GC4419 Cisplatin q3wk had n=30
B-OM q3wk arm beat all the drugs including GC4419 but only had n=8. Note the B-OM q3wk ITT n=8 was 25% (2/
and the PP n=7 was 14.3% (1/7).
B-OM qwk was roughly equal to placebo.
A few extra getting SOM in the B-OM trial swings those numbers 10-30 percentage points higher. Add a few more incidences of SOM to any GC4419 arm and it still trounces placebo. We all got burned on this "small n" in the Prurisol trials.
Granted, the B-OM placebo arm was significantly more effective than in any other trial. I'm not sure if that is good or bad. Did the weather or Jello that day serve to bolster both the placebo results and the B-OM results? No telling.
GC4419 had a large enough phase 2b trial and demonstrated substantial superiority against all other treatments aside from the small B-OM q3wk arm. It is almost certain to succeed in phase 3 and become the dominant OM treatment. This is why it received BTD.
Brilacidin-OM exhibited greater potential in the q3wk compared to GC4419. That, combined with being a mouth rinse vs IV, will make it the dominant treatment IF it replicates these numbers in phase 3. Given our small n, it is still much more of an IF compared to Galera's near certain phase 3 success. I believe that is why BTD was not granted to B-OM. If we replicate our q3wk arm with n=30 on an interim look I think we'll get BTD.
Galera investors are surely rooting for B-OM phase 3 failure as it is the only thing that can snatch billions/year away from them at this point.
I would also like to see what GC4419 combo'd with B-OM does. Possibly the true future of OM treatment right there.
GC4419 Cisplatin q3wk had n=30
B-OM q3wk arm beat all the drugs including GC4419 but only had n=8. Note the B-OM q3wk ITT n=8 was 25% (2/
and the PP n=7 was 14.3% (1/7). B-OM qwk was roughly equal to placebo.
A few extra getting SOM in the B-OM trial swings those numbers 10-30 percentage points higher. Add a few more incidences of SOM to any GC4419 arm and it still trounces placebo. We all got burned on this "small n" in the Prurisol trials.
Granted, the B-OM placebo arm was significantly more effective than in any other trial. I'm not sure if that is good or bad. Did the weather or Jello that day serve to bolster both the placebo results and the B-OM results? No telling.
GC4419 had a large enough phase 2b trial and demonstrated substantial superiority against all other treatments aside from the small B-OM q3wk arm. It is almost certain to succeed in phase 3 and become the dominant OM treatment. This is why it received BTD.
Brilacidin-OM exhibited greater potential in the q3wk compared to GC4419. That, combined with being a mouth rinse vs IV, will make it the dominant treatment IF it replicates these numbers in phase 3. Given our small n, it is still much more of an IF compared to Galera's near certain phase 3 success. I believe that is why BTD was not granted to B-OM. If we replicate our q3wk arm with n=30 on an interim look I think we'll get BTD.
Galera investors are surely rooting for B-OM phase 3 failure as it is the only thing that can snatch billions/year away from them at this point.
I would also like to see what GC4419 combo'd with B-OM does. Possibly the true future of OM treatment right there.
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