Patients in U.S. Clinical Trials Injected with 150,000 human embryonic stem cell-(hESC) derived Retinal Pigment Epithelial Cells
ACT Initiates Treatment of Higher-Dosage Cohort in Clinical Trials for Dry Age-Related Macular Degeneration and Stargardt’s Macular Dystrophy
<0> Investors:CEOcast, Inc.James Young, 212-732-4300orPress:ACT Corporate CommunicationsBill Douglass, 646-450-3615or:Russo PartnersMartina Schwarzkopf, Ph.D., 212-845-4292 </0>
Advanced Cell Technology, Inc. (“ACT”; OTCBB: ACTC), a leader in the field of regenerative medicine, today announced treatment of patients in the third patient cohort, in each of its two U.S. clinical trials for forms of macular degeneration. The patients were injected with 150,000 human embryonic stem cell-(hESC) derived retinal pigment epithelial (RPE) cells, as compared with the 100,000-cell dose used in the previous three patients of the second cohort. The Stargardt’s Macular Dystrophy (SMD) patient was treated on Wednesday, March 27, at at the University of Miami Miller School of Medicine, with the patient with dry age-related macular degeneration (dry AMD) having been treated the prior day, at another clinical trial site. Both patients successfully underwent the outpatient transplantation surgery, and are recovering uneventfully.
“We are very pleased to have commenced with treatment of the third patient cohort in both of our U.S. clinical trials,” commented Gary Rabin, chairman and CEO of ACT. “We are eagerly anticipating completing this cohort and moving on to the fourth one. We are also looking forward to initiating treatment of patients with better vision in cohort 2a, for which we are currently reviewing and qualifying patients.”
Initiated in July 2011, the two Phase I trials are designed to determine the safety and tolerability of hESC-derived RPE cells following sub-retinal transplantation in patients with SMD and dry AMD at 12 months, the studies’ primary endpoint. Both trials will involve 16 patients, with cohorts of three patients each in an ascending dosage format and four patients with better vision, receiving 100,000 hESC-derived RPE cells. The company is concurrently conducting a second trial for SMD in Europe.
“We have now treated 20 patients,” said Robert Lanza, M.D., chief scientific officer. “We are encouraged by the steady progress of our U.S. clinical trials, and are eagerly anticipating initiating treatment of the third patient cohort in our European trial, as well.”
Further information about patient eligibility for ACT’s SMD study and the concurrent studies in the U.S. and Europe (for dry age-related macular degeneration and SMD, respectively) are available at , with the following Identifiers: NCT01345006 (U.S. SMD), NCT01344993 (dry AMD), and NCT01469832 (E.U. SMD).
Advanced Cell Technology, Inc. is a biotechnology company applying cellular technology in the field of regenerative medicine. For more information, visit .