ACT Initiates Treatment of Higher-Dosage Cohort in Clinical Trials for Dry Age-Related Macular Degeneration and Stargardt's Macular Dystrophy
Patients in U.S. Clinical Trials Injected with 150,000 human embryonic stem cell-(hESC) derived Retinal Pigment Epithelial Cells
MARLBOROUGH, Mass.--(BUSINESS WIRE)-- Advanced Cell Technology, Inc. ("ACT"; OTCBB: ACTC), a leader in the field of regenerative medicine, today announced treatment of patients in the third patient cohort, in each of its two U.S. clinical trials for forms of macular degeneration. The patients were injected with 150,000 human embryonic stem cell-(hESC) derived retinal pigment epithelial (RPE) cells, as compared with the 100,000-cell dose used in the previous three patients of the second cohort. The Stargardt's Macular Dystrophy (SMD) patient was treated on Wednesday, March 27, at Bascom Palmer Eye Institute at the University of Miami Miller School of Medicine, with the patient with dry age-related macular degeneration (dry AMD) having been treated the prior day, at another clinical trial site. Both patients successfully underwent the outpatient transplantation surgery, and are recovering uneventfully.
"We are very pleased to have commenced with treatment of the third patient cohort in both of our U.S. clinical trials," commented Gary Rabin, chairman and CEO of ACT. "We are eagerly anticipating completing this cohort and moving on to the fourth one. We are also looking forward to initiating treatment of patients with better vision in cohort 2a, for which we are currently reviewing and qualifying patients."
Initiated in July 2011, the two Phase I trials are designed to determine the safety and tolerability of hESC-derived RPE cells following sub-retinal transplantation in patients with SMD and dry AMD at 12 months, the studies' primary endpoint. Both trials will involve 16 patients, with cohorts of three patients each in an ascending dosage format and four patients with better vision, receiving 100,000 hESC-derived RPE cells. The company is concurrently conducting a second trial for SMD in Europe.
"We have now treated 20 patients," said Robert Lanza, M.D., chief scientific officer. "We are encouraged by the steady progress of our U.S. clinical trials, and are eagerly anticipating initiating treatment of the third patient cohort in our European trial, as well."
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 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.
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, 2012.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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