ACT Announces Completion of Higher-Dosage Cohort in Both U.S. Clinical Trials
Three Patients with Forms of Macular Degeneration Injected with 100,000 hESC-Derived RPE Cells, Successfully Completing Second Cohort
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.”
Added Dr. Eliott, “Dry AMD affects upwards of 30 million people worldwide. Moreover, it has no approved drug treatment available to date. ACT’s hESC-derived RPE cells could address this considerable unmet need and also point the way towards treatments of other forms of macular degeneration. We are pleased to be a part of this important clinical trial.”
Further information about patient eligibility for ACT’s dry AMD study and the concurrent studies in the U.S. and the E.U. for SMD is available at www.clinicaltrials.gov with the following Identifiers: NCT01344993 (dry AMD), NCT01345006 (U.S. SMD) and NCT01469832 (E.U. SMD).
About Advanced Cell Technology, Inc.
Advanced Cell Technology, Inc., is a biotechnology company applying cellular technology in the field of regenerative medicine. For more information, visit www.advancedcell.com.
About Mass. Eye and Ear
Mass. Eye and Ear clinicians and scientists are driven by a mission to find cures for blindness, deafness and diseases of the head and neck. After uniting with Schepens Eye Research Institute in 2011, Mass. Eye and Ear in Boston became the world's largest vision and hearing research center, offering hope and healing to patients everywhere through discovery and innovation. Mass. Eye and Ear is a Harvard Medical School teaching hospital and trains future medical leaders in ophthalmology and otolaryngology, through residency as well as clinical and research fellowships. Internationally acclaimed since its founding in 1824, Mass. Eye and Ear employs full-time, board-certified physicians who offer high-quality and affordable specialty care that ranges from the routine to the very complex. U.S. News & World Report’s “Best Hospitals Survey” has consistently ranked the Mass. Eye and Ear Departments of Otolaryngology and Ophthalmology as top five in the nation. Mass. Eye and Ear is home to the Ocular Genomics Institute which aims to translate the promise of personalized genomic medicine into clinical care for ophthalmic disorders. For more information, visit MassEyeAndEar.org.
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James Young, 212-732-4300
ACT Corporate Communications
Bill Douglass, 646-450-3615
Martina Schwarzkopf, Ph.D., 212-845-4292