Patients with Better Vision to be Enrolled in ACT's Clinical Trials for Macular Degeneration
Patients with 20/100 Vision Will Now be Eligible for Enrollment, Expanding Patient Base and Potentially Accelerating Pace of Trials
MARLBOROUGH, Mass.--(BUSINESS WIRE)-- Advanced Cell Technology, Inc. ("ACT"; OTCBB: ACTC or the "Company"), a leader in the field of regenerative medicine, announced today that it is amending the patient treatment protocol for the remainder of the Company's Phase I clinical trials for Stargardt's macular dystrophy (SMD) and dry age-related macular degeneration (dry AMD) currently being conducted in the U.S. and will also submit an amendment in Europe for the SMD trial being conducted there. Patients with better vision, a visual acuity of 20/100, will be eligible for enrollment in the remainder of the trials. By treating patients earlier in the course of the disease, the Company believes that the amended patient protocol will 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.
"Having recently reached the halfway point in our three clinical trials for macular degeneration, now is an opportune time to pursue modifications which could help accelerate the pace of all three trials," said Gary Rabin, chairman and CEO. "The advanced age of many of our enrolled patients has tended to limit the pace at which we are able to enroll and treat them, since other, unrelated health complications tend to come up more frequently in the elderly. Patients with better vision tend to be younger on average."
The Company plans to institute the amended patient protocols upon receipt of Institutional Review Board (IRB) approval from each of the clinical sites, for the second half of all the clinical trials.
"We are pleased to be able to expand patient enrollment in all three of our ongoing clinical trials," said Robert Lanza, M.D., ACT's chief scientific officer. "Not only does it have the potential to accelerate the road to the completion of Phase I, but having a more diverse patient population could also provide additional clinical insights."
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
Bill Douglass, 646-450-3615
Martina Schwarzkopf, Ph.D., 212-845-4292
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