Schwartz to present OCAT trial results at AAO 2015

Reading center? Sorry I may have missed something

Shwartz's comments

"So, 72% of our patients have visible pigmentation, and this patient actually was not published in the paper. This is a different cohort of patients. So, once we showed safety, the agency...the FDA....said, 'okay, you can now start transplanting in less severely ill eyes'. So, we moved into what I call a better vision cohort. This patient started out with 20/150 vision, and we showed you this picture before. We transplanted them, and within 6 months the transition zone looks more pigmented, but there is also some tissue underneath the center of the retina...underneath the center of the atrophy and... At one year, there is even more....and... If you look at the OCT (i.e. Optical Coherence Tomography) and you.....Brandon, I'd be interested in what you think...but here's the baseline: no RPE. See the RPE here....and..and... There's all sorts of weirdness going on in the central retina. Then, the RPE picks up again. Here at six months, you have a new sheet of RPE, at least it sure looks like RPE and maybe the retina is changing a little. I can't tell. I don't know if anyone's gonna buy that. At one year, it is changing a little more. I had an 18 month follow up on this patient recently, and maybe even some more remodeling within the (inaudible) retina and maybe the outer segments are coming together a little bit better....and...you know..... This is going to go over to a reading center.

Yeah, I agree there must be a plan for some type of new data in order for him to be presenting here. Can't see why he would be listed here to present data that is already out there. Just wish they had started P2 early this year because then they would have P2 data to present at this really big meeting. 

Just bumping this since it is next weekend, Nov 13/14.

In case anyone still cares , looks like Schwartz just presented the Lancet results. Thanks to Irv for posting elsewhere.

www.retinalconsultantsaz.net/news-topic.php?newsid=99

The results from the latest phase 1/2 clinical trials looking at the safety and tolerability of transplanted human embryonic stem cell-derived (hESC) RPE cells for atrophic AMD and Stargardt macular dystrophy were presented by Dr. Steven Schwartz. Transplanted patients were followed up for a median of 22 months. There was no evidence of adverse proliferation, immune rejection, or serious ocular or systemic safety issues related to the transplanted tissue. The only adverse events reported were associated with the surgical procedure itself and the systemic effects of postoperative immunosuppression. Best-corrected VA improved in ten eyes, remained the same in seven eyes, and decreased by more than ten letters in one eye. The untreated fellow eyes did not show similar improvements in VA. The results provide initial evidence of safety, graft survival, and possible biological activity of hESC-derived RPE cells for AMD and Stargardt macular dystrophy.

I can't believe their still presenting at all