Theratechnologies Inc T.TH

AACR Poster - very interesting

[Wino115]

So, the safety issues were not all that big --basic things we knew and <12%.  Still issues, but not the severe ones like seen in some ADCs.  Marsolais comment about being on  target and internalizing is helpful.  

We also know that there were some level or either partial responses or stability in ovarian, TNBC and prostate. So 3 of the cancers seen.  This is the first time we've actually heard about TNBC and that's a real positive.  Stable disease is not the ultiate result you want but does show there is an effect going on --the "concept" is there because a person with (avg) 8 previous treatments where nothing worked anymore actually survived and the metastices were controllable for some pretty long periods as you see --one for 40+ weeks which is a long, long, long time for someone on death's door.  Those SD rates and lengths are in there with other good cancer drugs.  

Nice to see the rock star investigator was willing to put her name on the PR talking about the results on the poster.   While it's still very important to see this data and the charts, we now know it will be for the full part 1 and 2 (so far) of 38 patients.  For a first time shot, seeing decent safety a few PRs and some very long SD's is actually a pretty good start.  It could just stay at that, but if there is something going on in there, which it seems there is now, finding a way to see more of the effect that is keeping the tumor stable to actually get in there and shrink it is what's needed.  It sounds like they will be trynig a few different techniques to "expand the window".   Overall, while we still need to see this data and to produce even better data, it's a nice start to round 3 in dosing the drug and seeing if it hits targets. It's certainly encouraging and not discouraging and makes the intereim stop seem more about them seeing it's having an effect but it needs to be tweaked to be better and we can see that --it's relativel safe and we see stability, so pause, reevaluate and let's get it coming back in a more effective way.

[palinc2000]

When were these results tabulated or extrated? Why the pause? I think it is all related to the cash situation. I smell a partnering deal as soon or soon after FDA apptoves the revised protocol  

[Wino115]

They got all the data together for the new protocal and the Scientific Adv Committee review and decision on whether to proceed and how. Typically you'd compile for a paper, but perhaps since they had to compile it all for the revision, FDA and that SAC, that is the data the investigator decided to publish and talk about.  I was certain they would only cover the first part of the trial

[SPCEO1]

It will certainly make the investor call they are planning more meaningful as had that data not been available we would be left wondering about some aspects of the trial. So, having all that data will be really helpful. Now, it has the potential to both increase or decrease our confidence in the restarted trial but at least we will go into it better informed.

[qwerty22]

So my take on their thought process (I'll be easily knocked from this with any new info) There is a serious lack of partial responses but the SD suggest they are possible. This is the reason for the pause. Even though you're not half way through the part 2 trial there's a strong risk of getting to the end of part 2 without the requisite PRs. This might be a fatal blow to the

[qwerty22]

Just as an aside. They really should have developed their clinical grade Sortilin test to the point where it can be intergrated into the trials (assuming they kept at it). I was hoping they'd have it for the end of phase 1 so it's post hoc analysis could inform phase 2. We would be at that point if the trial hadn't been paused. It would be a positive if they could announce they were

[Wino115]

I've thougth about that question too and knowing these things are always data driven, it seems to point to that. I've assumed some of the logic was that it showed very positive pre-clinical efficacy and safety, there's some sense with the very long SDs and PRs that conceptually it's getting there, but it's no where near the results to move it further. They basically came to

[palinc2000]

Great to to see these data come out. Bravo to our medical team and investigators. Paul Levesque  's short post on Linkendl  

[qwerty22]

An "interim read" would be a great way to understand the pause if that was what it was. It makes everything fall into place. We are still left with the fact that they concluded part 2 had a high probability of not reaching the goal that was set for it but it might put to bed some of the very negative options that have been going through my head. I'm liking that as a jumping off

[qwerty22]

I don't know what's going on with this press release. It reads as a fairly incomplete part 2 with lots of enrollment still to come, a smattering of hopium for efficacy but not quite getting enough of those all important PRs and manageable safety. It doesn't scream "STOP THIS TRIAL" and yet that's exactly what happened. Extreme conservatism????? or maybe the devil is