Advanced Cell Technology Achieves Clinical Milestone
Company is Halfway through Groundbreaking Clinical Trials; Evidence of Engraftment and Function Observed; No Safety Issues Reported
MARLBOROUGH, Mass.--(BUSINESS WIRE)--Jan 8, 2013 - Advanced Cell Technology, Inc. (“ACT”; OTCBB: ACTC or the “Company”), a leader in the field of regenerative medicine, announced today that investigators for the Company's Phase I/II clinical trials for Stargardt's macular dystrophy (SMD) and dry age-related macular degeneration (dry AMD) have observed evidence of engraftment of the transplanted human embryonic stem cell (hESC)-derived retinal pigment epithelial (RPE) cells and visual acuity gain in patients treated over the 18 months since the trials were first initiated. The Company believes this observation of engraftment and persistence is clinically important because engraftment of cells in the proper area, and recapitulation of normal RPE cell layer structure is important to the ultimate efficacy of the RPE cells in the treatments. Additionally, investigators have not observed any issues of safety relating to the transplanted human embryonic stem cell (hESC)-derived RPE cells in any of the 18 patients treated. The company believes this warrants early (though cautious) optimism as the company looks forward to initiating the second half of the three trials.
“Now that we are at the halfway point in all three of our ongoing trials, we have had the opportunity to stop and assess not only the data relating to safety, but also to the activity of the transplanted RPE cells,” said Gary Rabin, chairman and CEO. “In our first report of hESC-derived cells transplanted into patients, published in the Lancet, we reported no adverse safety signals and that both patients that had been treated by that point showed some signs of visual improvements. For both of those patients, those gains in visual acuity have persisted for nearly 18 months now. In addition, we have observed persisting engraftment of the transplanted RPE cells in our more recent SMD and dry AMD patients. This is the first time we have shown this in dry AMD patients, which we find particularly encouraging, given that dry AMD represents one of the largest unmet medical needs in the world.”
“We are optimistic about the prospects of our RPE cells ultimately impacting positively on various forms of macular degeneration,” said Robert Lanza, M.D., ACT's chief scientific officer. “As we have added additional clinical trial sites, the pace of patient treatments has picked up. At the same time, we are extending our observations to a greater number of patients, as well as collecting data over extended periods of time after the surgery.”
Mr. Rabin will be providing an overview of the company's progress, including providing some representative examples of anatomical data of RPE engraftment in the trials, in his presentation on Tuesday, Jan. 8 at Biotech Showcase 2013 in San Francisco. Pictures of the engraftment will be included in Mr. Rabin's presentation, which will be posted to the Presentations section of the ACT site, and a link to a webcast of the presentation will be available on the Events section.
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
Posted: January 2013