ACT Announces Completion of Higher-Dosage Cohort in European Clinical Trial for Stargardt's Macular Dystrophy
Halfway Point Now Reached In All Three Phase I/II Embryonic Stem Cell-Based Clinical Trials
MARLBOROUGH, Mass.--(BUSINESS WIRE)-- Advanced Cell Technology, Inc. ("ACT"; OTCBB: ACTC or the "Company"), a leader in the field of regenerative medicine, today announced treatment of the fifth and sixth patients in the company's European clinical trial for Stargardt's Macular Dystrophy (SMD) using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs), completing the second patient cohort. The patients were injected with 100,000 hESC-derived RPE cells, as compared to 50,000 cells in the first cohort. The outpatient transplantation surgeries were performed successfully and the patients are recovering uneventfully.
"Having completed the second, higher-dose patient cohort in all three of our clinical trials in the U.S. and Europe, we are now officially at the halfway point in all three, which we find very gratifying," commented Gary Rabin, chairman and CEO of ACT. "We have been able to add new trials sites and consequently to quicken the pace of patient enrollment in our ongoing trials. We feel this should also serve to hasten the pace at which we are able to complete the second half of the trials."
The E.U. clinical trial is one of the three trials being carried out by the company 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 all three of our trials is a significant milestone in our RPE program," said Robert Lanza, M.D., ACT's chief scientific officer. "At our current pace of patient treatments, we should be on track to complete all three trials in 2013."
Further information about patient eligibility for ACT's SMD trial in the E.U. and the concurrent U.S. trials for SMD and dry AMD study are available at www.clinicaltrials.gov with the following Identifiers: NCT01469832 (E.U. SMD), NCT01345006 (U.S. SMD) and NCT01344993 (dry AMD).
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.
Statements in this news release regarding future financial and operating results, future growth in research and development programs, potential applications of our technology, opportunities for the company and any other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words "will," "believes," "plans," "anticipates," "expects," "estimates," and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements, including: limited operating history, need for future capital, risks inherent in the development and commercialization of potential products, protection of our intellectual property, and economic conditions generally. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in the company's periodic reports, including the report on Form 10-K for the year ended December 31, 2011. Forward-looking statements are based on the beliefs, opinions, and expectations of the company's management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. Forward-looking statements are based on the beliefs, opinions, and expectations of the company's management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. There can be no assurance that the Company's clinical trials will be successful.
James Young, 212-732-4300
ACT Corporate Communications
Bill Douglass, 646-450-3615
Martina Schwarzkopf, Ph.D., 212-845-4292
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