MARLBOROUGH, Mass.--(BUSINESS WIRE)--Advanced Cell Technology, Inc. (“ACT”; OTCBB:ACTCD), a leader in the field of regenerative ophthalmology, announced today that it has completed treatment of the final patient in its U.K. based Phase 1 clinical trial for Stargardt’s macular degeneration (SMD). The successful transplantation of the Company’s proprietary RPE cells in the last patient of twelve represents the completion of the enrollment stage of this trial. The trial is a prospective, open-label study designed to determine the safety and tolerability of the Company’s RPE cell therapy following sub-retinal transplantation into patients.
“The completion of enrollment and treatment of all patients in the Phase 1 portion of our U.K. clinical trial is a significant milestone for ACT and its RPE programs,” said Eddy Anglade, M.D., ACT’s Chief Medical Officer. “We look forward to analyzing the data as we continue to advance our clinical programs. To date, no cell or immune-related adverse events have been reported in any of the patients treated; indicating that our RPE cell therapy appears to be safe and well-tolerated at all of the doses planned for the study.”
As previously announced, the Company is working with regulatory agencies in the U.S. and Europe to commence multi-site Phase 2 clinical trials to further examine the efficacy and safety of its RPE cell therapy in patients suffering from SMD, as well as dry age-related macular degeneration (AMD).
Paul K. Wotton, Ph.D., President and Chief Executive Officer, said, “This accomplishment is important for the Company, and I would like to thank our investigators and all of the patients who participated in this study. We will continue to advance the development of our novel cell therapy products that may ultimately help patients who suffer from debilitating diseases, such as SMD and AMD, both significant and unmet medical needs”
Further information regarding ACT’s SMD study in Europe is available at www.clinicaltrials.gov, with the following Identifier: NCT01469832.
About Advanced Cell Technology, Inc.
Advanced Cell Technology, Inc., (ACT) is a clinical stage biotechnology company focused on the development and commercialization of regenerative medicine and cell therapy technology. The company’s most advanced products are in clinical trials for the treatment of dry age-related macular degeneration, Stargardt’s macular degeneration and myopic macular degeneration. ACT’s preclinical programs involve cell therapies for the treatment of other ocular disorders and for diseases outside the field of ophthalmology, including autoimmune, inflammatory and wound healing-related disorders. The company’s intellectual property portfolio includes pluripotent stem cell platforms – hESC and induced pluripotent stem cell (iPSC) – and other cell therapy research programs. For more information, visit www.advancedcell.com.
Forward-Looking Statements
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 our report on Form 10-K for the year ended December 31, 2013 and our report on Form 10-Q for the three and six months ended June 30, 2014. 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 or other development programs will be successful.