ACT Treats First Patient with Better Vision in Clinical Trial for Stargardt's Macular Dystrophy
Patient Injected with 100,000 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 the first patient in patient cohort 2a, consisting of patients with better vision, in its U.S. clinical trial for Stargardt's Macular Dystrophy (SMD), a form of juvenile macular degeneration. The surgery was performed on Thursday, April 11 at Wills Eye Institute in Philadelphia, by Joseph Maguire, M.D., a co-investigator on the trial. The protocol is overseen by Principle Investigator, Carl D. Regillo, M.D., Chief of the Wills Eye Institute Retina Service, and professor of ophthalmology at Thomas Jefferson University. The patient was injected with 100,000 human embryonic stem cell-derived retinal pigment epithelial (RPE) cells. As the company announced on Jan. 22, patients with a visual acuity of 20/100 are eligible for enrollment in cohort 2a in the two U.S. clinical trials, for SMD and dry age-related macular degeneration (dry AMD). By treating patients earlier in the course of the disease, the Company believes that the amended patient protocol may have a more significant impact on photoreceptor rescue and visual function. In previous protocols, only SMD patients with a visual acuity no better than hand movement in the treated eyes and dry AMD patients with a visual acuity of 20/400 were eligible. The outpatient transplantation surgery was performed successfully and the patient is recovering uneventfully.
"We are pleased to have commenced treatment of the first patient in the cohort with better vision of our U.S. SMD trial," commented Gary Rabin, chairman and CEO of ACT. "Treatment of these patients will be critical in defining the future direction of our therapy. The data that we gather from these cases is instrumental in further understanding retinal disease impact, allowing us to improve clinical trial design for future phases and the ultimate commercialization strategy for our RPE program."
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 a total of 16 patients, with cohorts of three patients each in an ascending dosage format, as well as 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 continue to be encouraged by the steady progress of our trials," said Robert Lanza, M.D., chief scientific officer. "We are particularly pleased to have treated our first patient with better vision, and we look forward to seeing the results and to treating the first dry AMD patient with better vision, 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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