e-mail question to Rabin with his response from
poster "tmfbmf" on I-cell
Hi Gary. I noticed a discrepancy on the clinicaltrials.gov site:
“There will be 5 cohorts, the 4 low vision cohorts will contain 3 patients, the better vision cohort will contain 4 patients."
In paragraph 2 it says, “Three AMD patients- 50,000 MA09-hRPE cells transplanted Three AMD patients- 100,000 MA09-hRPE cells transplanted Three Better Vision AMD patients- 100,000 MA09-hRPE cells transplanted Three AMD patients- 150,000 MA09-hRPE cells transplanted Three AMD patients- 200,000 MA09-hRPE cells transplanted.”
Is the new cohort 3 or 4 better-vision patients? And will we be injecting better-vision patients with 150k and 200k cells as well?
Thanks!
Best regards,
------------------------
Hi Thomas,
Wow, good catch. I will tell the group that does those protocol changes to fix it. We are doing 4 patients in the new Cohort 2a. We felt that this was enough data given what we are trying to see across all three trials (i.e., it will total 12 additional patients treated with 100,000 cells). We feel that 100,000 cells injected into the area where we are forming the blebs is sufficient given the survival and attachment data we are seeing thus far. This is all to help us better design our treatments for Phase 2 and beyond. Also, we will hopefully be able to see an even greater level of engraftment in retinas with smaller fields of atrophy (as well as the potential for more substantial visual acuity changes). Our Ophthalmic Advisory Board was unanimous in this approach, and as you are aware, they are really the leaders in the field. I must say that the 20/100 patient population (particularly in the AMD) is a bit tricky though. They are at a crossroads where the rate of decline in their vision in the normal course of the disease is relatively rapid as compared to earlier or later onset stages of the disease. So lots of variables.
I hope this answers your questions.
Best,
Gary
