Institutional Review Board (IRB) Approves Phase 1/2 Trial for Stargardt’s Macular Dystrophy (SMD)
MARLBOROUGH, Mass. — May 16, 2011 – Advanced Cell Technology, Inc. (“ACT”; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that the Casey Eye Institute (CEI) at Oregon Health & Science University (OHSU) in Portland, Ore., has received institutional review board (IRB) approval to be a site for its Phase 1/2 human clinical trial for Stargardt’s Macular Dystrophy (SMD) using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs). The Phase 1/2 trial will be prospective, open-label study designed to determine the safety and tolerability of the RPE cells following sub-retinal transplantation into patients with SMD.
“We are pleased that OHSU’s Casey Eye Institute has agreed to participate as a site for this study that should help us better understand the role that RPE cells can play in the treatment of SMD,” said Gary Rabin, interim chairman and CEO of ACT. “This agreement marks another milestone in our history of successful collaboration with CEI on our RPE program. The promising data from the collaboration, begun in 2007, helped pave the way for this trial, and we look forward to starting it in the coming weeks.”
“We are honored to have been designated as a site for this groundbreaking clinical trial,” said Peter J. Francis, M.D., Ph.D., Associate Professor of Ophthalmology and Co-Director of the Oregon Retinal Degeneration Center at the Casey Eye Institute. “Our prior collaborative projects with ACT on its RPE program have generated promising results, and we are pleased to be a part of this trial for an exciting potential new treatment for SMD, using hESC-derived RPE cells.”
Additional details on this study, for which the Jules Stein Institute at the University of California, Los Angeles has also received IRB approval, can be found on http://clinicaltrials.gov/; ClinicalTrials.gov Identifier: NCT01345006.
About macular degeneration and SMD
Degenerative diseases of the retina are among the most common causes of untreatable blindness in the world. As many as thirty million people in the United States and Europe suffer from macular degeneration, which represents a $25-30 billion worldwide market that has yet to be effectively addressed.
Stargardt’s Macular Dystrophy (SMD) is one of the most common forms of macular degeneration in the world. SMD 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 or RPE cell layer.
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.
About Casey Eye Institute
As part of Oregon Health & Science University, the Casey Eye Institute is an academic regional eye center. It is named after James and George Casey, founders of United Parcel Service. The Casey Eye Institute is also one of only seven regional eye research centers in the nation sponsored by Research to Prevent Blindness, the world’s leading voluntary organization in support of eye research. The Casey Eye Institute has operated the Elks Children’s Eye Clinic since 1949, thanks to the generous support of the Oregon State Elks Association. www.ohsu.edu
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James Young, 212-732-4300
ACT Corporate Communications
Bill Douglass, 646-450-3615
Martina Schwarzkopf, Ph.D., 212-845-4292