After Nov14th, ACT should have data for approval of 4 new patients for AMD trials second group of 100,000.
ACT treats first patient in second cohort of Phase I/II dry AMD trial
7 days 23 hours 49 minutes ago - Datamonitor via Comtex
Advanced Cell Technology, Inc., or ACT, a provider of regenerative medicine, has announced treatment of the fourth patient, the first in the second patient cohort, in the company's Phase I/II clinical trial for dry age-related macular degeneration, or dry AMD, using retinal pigment epithelial, or RPE, cells derived from human embryonic stem cells, or hESCs.
The patient was injected with 100,000 hESC-derived RPE cells and is recovering uneventfully. The dry AMD trial is one of three clinical trials being carried out by the company in the US and in Europe. Each trial will enroll 12 patients, with cohorts of three patients in an ascending dosage format.
These trials are prospective, open-label studies, designed to determine the safety and tolerability of hESC-derived RPE cells following sub-retinal transplantation into patients with dry AMD or Stargardt's macular dystrophy (SMD) at 12 months, the study's primary endpoint.
"We are very pleased to have the second dose cohort in both of our US clinical trials underway," commented Gary Rabin, chairman and CEO of ACT. "We are encouraged by our ongoing progress in all three of our clinical trials using our hESC-derived RPE cells to treat forms of macular degeneration. We have not observed any complications or side effects from the stem cell-derived RPE cells, and we will continue to monitor the patients for safety, tolerability and efficacy of this therapy."
"Doubling the cell dosage in both our US trials is an important step forward in our clinical programs," said Robert Lanza, ACT's chief scientific officer. "We anticipate continued progress and safety findings in both our US trials as well as our concurrent European trial."
No hunch, just reading the news and approval process.
The data from Maurie was gathered after 6 weeks. Gave approval for more patients 6 weeks after that.
If the same time line is used, December 26th, or thereabouts, approval from DSMB for 4 more AMD 100,000 dose patients. Merry Christmas if the news comes early,Happy New Year if holidays delay things.