ACT Announces First Stargardt Patient Treated With Higher Dosage of Embryonic Stem Cell-Derived Retinal Pigment Epithelial Cells
Patient Injected with 100,000 RPE Cells at Wills Eye Institute
MARLBOROUGH, Mass.--(BUSINESS WIRE)--Jul 12, 2012 - 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 its U.S. clinical trial for Stargardt's Macular Dystrophy (SMD). The surgery was performed on Wednesday, July 11 at Wills Eye Institute in Philadelphia, by a surgical team lead by Carl D. Regillo, MD, FACS, director of the Wills Eye Clinical Retina Research Unit, attending surgeon in the Wills Eye Retina Service at the Wills Eye Institute, and professor of ophthalmology at Thomas Jefferson University. In keeping with trial protocol, the patient was injected with 100,000 human embryonic stem cell-derived retinal pigment epithelial (RPE) cells, as compared with the 50,000 cell dose used in the three patients of the first cohort. The outpatient transplantation surgery was performed successfully and the patient is recovering uneventfully.
“It is very gratifying to have second cohort, higher-dosage patient treatment underway in our U.S. clinical trial for SMD,” commented Gary Rabin, chairman and CEO of ACT. “We are also pleased to be working with Dr. Regillo and his team at Wills Eye Institute, a truly first-class institution that is ranked as one of the best ophthalmology hospitals in the country by U.S. News & World Report.”
Initiated in July of last year, the Phase I/II trial is designed to determine the safety and tolerability of hESC-derived RPE cells following sub-retinal transplantation in patients with SMD at 12 months, the study's primary endpoint. It will involve a total of 12 patients, with cohorts of three patients each in an ascending dosage format. As part of its RPE clinical program, the company is concurrently conducting a clinical trial for dry age-related macular degeneration and second trial for SMD in the United Kingdom.
“Doubling the cell dosage marks an important milestone in our clinical programs,” said Robert Lanza, MD, ACT's chief scientific officer. “We look forward to continued progress and safety findings in the coming months, in both our U.S. and European trials.”
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 www.clinicaltrials.gov, with the following Identifiers: NCT01345006 (U.S. SMD), NCT01344993 (dry AMD), and NCT01469832 (E.U. SMD).
About Stargardt's Disease
Stargardt's disease or Stargardt's Macular Dystrophy is a genetic disease that causes progressive vision loss, usually starting in children between 10 to 20 years of age. Eventually, blindness results from photoreceptor loss associated with degeneration in the pigmented layer of the retina, called the retinal pigment epithelium, which is the site of damage that the company believes the hESC-derived RPE may be able to target for repair after administration.
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 http://www.advancedcell.com.
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Posted: July 2012