Data and Safety Monitoring Board (DSMB) Grants Approval to Proceed with Treatment of Second Patient Cohort
MARLBOROUGH, Mass. — July 9, 2012 – Advanced Cell Technology, Inc. (“ACT”; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that the Data and Safety Monitoring Board (DSMB), an independent group of medical experts closely monitoring the company’s three ongoing clinical trials, has authorized the company to move forward with enrollment and treatment of additional patients in its clinical trial for dry age-related macular degeneration (dry AMD). ACT will proceed with patient screening and enrollment for the second cohort, who, in keeping with trial protocol, will be injected with 100,000 retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs), as compared with the 50,000-cell dose used in the first cohort.
“DSMB authorization to move to the higher dosage of cells in our clinical trial for dry AMD represents a significant milestone for our clinical programs,” commented Gary Rabin, chairman and CEO of ACT. “Our RPE program is now advancing rapidly, as we are now screening at multiple ophthalmological centers for the fourth surgery in both our dry AMD trial and our U.S. SMD trial, with our E.U. SMD trial, which was initiated much later, not far behind.”
The trial is a prospective, open-label study, designed to determine the safety and tolerability of hESC-derived RPE cells following sub-retinal transplantation into patients with dry AMD at 12 months, the study’s primary endpoint. The three procedures comprising the first cohort of patients were all conducted at University of California at Los Angeles (UCLA), by Steven Schwartz, M.D., Ahmanson Professor of Ophthalmology at the David Geffen School of Medicine at UCLA and retina division chief at UCLA's Jules Stein Eye Institute. It was announced in May that Mass Eye and Ear is an additional site for the trial.
Mr. Rabin added, “Dry AMD represents one of the largest unmet ophthalmological needs in the world, with a potential market of $25 billion in the U.S. and Europe, alone, and this DSMB approval is a big step toward being able to potentially address that massive medical need.”
ACT is conducting a total of three clinical trials in the U.S. and Europe using hESC-derived RPE cells to treat forms of macular degeneration. Each trial will enroll a total of 12 patients, with cohorts of three patients each in an ascending dosage format. Treatment of the final patient of the first cohort in the company’s dry AMD trial was announced on April 20. On June 29, the second SMD patient enrolled in the Company’s E.U. clinical trial was treated at Moorfields Eye Hospital in London, U.K., and on April 24 the company announced DSMB approval to treat the second patient cohort in its U.S. SMD trial.
Further information about patient eligibility for ACT’s dry AMD study and the company’s concurrent SMD studies in the U.S. and E.U. 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.
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