Thursday 15th July - NEJM, page-52

No doubt whatsoever. The NEJM article will be about our DREAM-HF trial.

Starting around the 25 minute mark:

And so we designed a phase 3 trial called DREAM-HF, that isnow finished. And we have a one-year follow-up and this is a large study inthis terms with 570 patients that was done across fifty-two sites in the US andCanada and passed a series of pre-specified analyses, which is very importantin this kind of trial. So, you have asense that you're making progress and going in the right direction. So I'mgoing to show you two slides from this because these are part of the pressrelease and this is what I'll end with. But …and I could [laughs]….we're…I'mpreparing a manuscript for the New England Journal of Medicine on this, and Ijust want to tease you with something… and this is kind of similar to what Ishowed you before in our very beginning experience back in the early 2000s.

This is the primary endpoint, recurrent hospitalizations inthe two groups. This is 537 patients, no difference. Okay? But we’ve learned alot since then, and we've learned how to look at these events. So this particularthing where people are short of breath, and they come into the hospital, thecells did not affect that.

But, the cells did affect how many people had heart attacks,how many people had strokes, and death as well (that's not on this slide). AndI can sort of start showing you that with these cells over a period of…you cansee there, the average follow-up is 2000 days or a period of five years, have a60% reduction in heart attacks and stroke by giving these patients an injectionof these cells up front. So I'll justleave you with that teaser. You will hear more about this, but I just want totell you that this now is in the realm of...it's not an objective truth… wehave so much to find out about this...but this is very objective evidence thatreally is something we go to the FDA with, and that the FDA can then say, “Oh,we see evidence of this. Let's let you, then, maybe turn this into an actualpractical treatment.”

So, as you get data over time, we start getting into what wecall a slope of enlightenment and these very promising treatments that are justhyped in the beginning, as we have science and data supporting findings, we nowget to a point …and that is the point that we're at with stem cell therapy forheart failure, very specifically, in which we…there is a lot of data and hopethat we are very close to an approval of this treatment.