MARLBOROUGH, Mass.–(BUSINESS WIRE)–
Advanced Cell Technology, Inc. (ACT; OTCBB: ACTC), a leader in the field of regenerative medicine, today announced treatment of the fourth patient, the first in the second patient cohort, in the companys Phase I/II clinical trial for dry age-related macular degeneration (dry AMD) using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs). The surgery was performed on Wednesday, Aug. 1 atWills Eye Institutein Philadelphia, by a surgical team lead by Carl D. Regillo, M.D., Chief of the Wills Eye Institute Retina Service, and professor of ophthalmology at Thomas Jefferson University. The patient was injected with 100,000 hESC-derived RPE cells and is recovering uneventfully.
We are very pleased to have the second dose cohort in both of our U.S. 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.
The dry AMD trial is one of three clinical trials being carried out by the company in the U.S. 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 studys primary endpoint. Preliminary results from the two U.S. trials were reported in The Lancet earlier this year.
Doubling the cell dosage in both our U.S. trials is an important step forward in our clinical programs, said Robert Lanza, M.D., ACTs chief scientific officer. We anticipate continued progress and safety findings in both our U.S. trials as well as our concurrent European trial.
Dry AMD is the most common cause of vision loss in patients over 50 years and affects around 30 million people worldwide, said Dr. Regillo. Dry AMD is a form of macular degeneration with no approved drug treatment available to date. ACTs hESC-derived RPE cells could address the unmet medical need of combating dry AMD and other macular degenerations such as Stargardts disease. We are looking forward to analyzing the safety and efficacy data.
Further information about patient eligibility for ACTs dry AMD study and the concurrent studies in the U.S. and the E.U. for SMD is available atwww.clinicaltrials.gov,with the following Identifiers: NCT01344993 (dry AMD), NCT01345006 (U.S. SMD), and NCT01469832 (E.U. SMD).
About dry AMD
Degenerative diseases of the retina are among the most common causes of untreatable blindness in the world. Age-related macular degeneration (AMD) is the leading cause of blindness in people over age 60 in the United States, and the vast majority of cases of AMD are of the dry form, which is currently untreatable.
About Advanced Cell Technology, Inc.