Interesting update on the CHF trial. Most of it similar to the original release but giving more details, and also a new exciting analysis (post size limited , so I’ll split to 2 parts):
(1) Over all patients, in both classes, with a median follow up of 2.5 years, the 60% reduction in MI and strokes is repeated. The new information is the numbers: we know now it was 5% with MI or Stroke in the treatment arm, and 13% in the control arm. Indeed 8/13 is 61.5% which is the reduction. There is still an unclear nuance here. If a patient had 2 heart attacks… is it counted twice? Or once? , Well, the fact we are given these 5%,13% numbers, which can only be interpreted as a percentage from the overall number of patients in each group, we can deduce it is the latter, that is a patient is counted once, when the first event occurs. This btw leaves a room for even more improvement by measuring the TOTAL number of events. This should be at least as big as this, and probably bigger, as some patients will have several consecutive MI/Stroke events. The total number is interesting as well since each MI or Stroke event is a major lengthy dangerous and expensive admission.
(2) See part II of the post: discussing the new analysis given.
(3) We finally get the CV death numbers for Stage II patients: 8% vs. 20% , I estimated in the past it will be something like 6 vs 15 patients, and we see slightly larger numbers: 8 vs 20. P value is 0.03. This is a very important result. Together with the other results, it seems real. However, sadly this is still a sub analysis , as this is only for stage II patients. But what a glorious one !!.
(4) New analysis for 3 point MACE, given over all the patients, showing a 20% vs 30% which is excellent. They used the “easier” MACE with cv deaths instead of overall mortality, but the FDA had accepted that definition as well in the past. It’s not exactly stated again, if this is counting overall events, or just who had any of them. I suspect the latter, as we know from the average rate analysis there was a much bigger difference in the overall numbers. As expected these numbers are much stronger for stage II: 13% vs. 29%. Now, something should be clear here. We can extrapolate and see that the unreported numbers for stage III would have been ~27% vs. ~31% for the stage III patients, which would not be significant. This means, rex-L worked much better on stage II patients, and in this specific measure, almost didn’t work for stage III patients. We keep seeing the overall p value, only since it was so strong for stage II patients. However – I wonder what is the average number of MACE hospitalizations for stage III patients…. Seeing the previous measure… I think it is a safe hypothesis that this reduction will be significant in stage III patients as well !!! why? Since it is SO significant… I think it will be an important analysis to release , that will measure if successful a very important measure for stage III patients, and a real benefit for them as well.
(5) We got none of the many additional analysis to be done in this trial: admissions by length, type, severity, etc, patients moved to LVAD or transplant, LV echo cardiogram measurements before and after and during. There’s still pure gold and gems hidden there. I believe MESO came out quickly with this PR, since the result on the rate of MACE admissions, is MAJOR and nothing short of huge. It can be a game changer in this trial.
Part 2:
In the new PR we got a new piece of information: “Patients who received rexlemestrocel-L had a 68% reduction in the rate of recurrent hospitalizations from non-fatal heart attacks or strokes compared with controls, with a hospitalization rate of 1.90 per 100 patientyears of follow-up in the rexlemestrocel-L arm versus 5.95 per 100 patient-years of follow-up in the control arm (p=0.0002).” What does this mean?? And what is the difference between this and primary endpoint?? It looks very similar, right?? So did the trial all of a sudden passed the primary??? OK, this is still vague to some extent, but a few points (see part 3):Part 3:(1) The original primary endpoint is: “Time to recurrent non-fatal decompensated heart failure major adverse cardiac events (HF-MACE) that occur prior to the first terminal cardiac event (TCE).“ sounds very similar to “the rate of recurrent hospitalizations from non-fatal heart attacks or strokes” right?... well not exactly…(follow with part 4, shortly... when Invest posts it.. am hoping he'll get irritated enough, he'll start posting on HC... 
- up 26% premarket in the US, btw...)
(20min delay)