Advanced Cell Technology, Inc. (“ACT”; OTCBB: ACTC or the “Company”), a leader in the field of regenerative medicine, today announced treatment of three additional patients in the company’s two U.S. trials using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs). The fifth and sixth patients in the company’s Phase I/II clinical trial for dry age-related macular degeneration (dry AMD) were treated, completing the second patient cohort. The fifth patient was treated at Massachusetts Eye and Ear Infirmary, a Harvard Medical School affiliate, by a surgical team led by Dean Eliott, M.D., a full-time retina surgeon, scientist and associate director of the Retina Service at Mass. Eye and Ear. Additionally, the sixth patient in the company’s clinical trial for Stargardt’s Macular Dystrophy (SMD) was treated, also completing that second cohort. All three patients were injected with 100,000 hESC-derived RPE cells and are recovering uneventfully.
“We could not be more pleased to have now completed the second, higher-dose patient cohort in both of our U.S. clinical trials,” commented Gary Rabin, chairman and CEO of ACT. “We continue to be encouraged by our progress in all three of our clinical trials and are eagerly anticipating proceeding to the third, 150,000-cell patient cohort.”
The company is conducting a total of three clinical trials in the U.S. and Europe. Each trial will enroll a total of 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 SMD at 12 months, the study’s primary endpoint. Preliminary results from the two U.S. trials were reported in The Lancet earlier this year.
“Completing the higher-cell dosage in both our U.S. trials is an important milestone in our clinical programs,” said Robert Lanza, M.D., ACT’s chief scientific officer. “We are now halfway through both U.S. trials, and look forward to treating the remaining two patient cohorts in the coming year.”