Advanced Cell Technology Announces Interim Data from Its Three Ongoing Macular Degeneration Trials
Company To Discuss Data as Part of Third Quarter Financial Results on Today's Conference Call
MARLBOROUGH, Mass.--(BUSINESS WIRE)--Nov 8, 2012 - Advanced Cell Technology, Inc. (“ACT”; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that its upcoming conference call on its third quarter financial results will also provide some representative examples of data being collected from patients in its clinical trials for forms of macular degeneration. The Company has treated 13 patients thus far in its three ongoing trials for dry age-related macular degeneration (dry AMD) and Stargardt's Disease (SMD) using human embryonic stem cell (hESC)-derived retinal pigment epithelial cells. The first two trials were initiated in July of 2011. The three clinical trials involve four of the top-ranked eye hospitals in the U.S., and two of the leading eye hospitals in the U.K.
Across the various clinical trial sites, with regular patient follow-up, no adverse safety issues relating to the transplanted cells have been observed. At up to 16 months following treatment, no hyperproliferation, tumorigenicity, ectopic tissue formation, or apparent rejection were observed in any of the 13 patients at any time. Detailed clinical and diagnostic laboratory assessments were performed at multiple post-transplantation evaluations. In addition to monitoring the safety of the transplanted cells, the clinicians have also been carefully assessing patients – on regular follow-up visits – for evidence of anatomical and functional integration of the RPE cells. The RPE layer plays a central role in the health and function of the photoreceptor layer. In treating various forms of macular degeneration, such as dry AMD and SMD, the goal of the company's RPE cell therapy is for repair and replacement of those areas in the eye where the RPE layer has degraded with new cells, and in doing so, recapitulate the correct working environment around the photoreceptor layer. At a recent meeting of the various U.S. and U.K. surgeons leading the clinical trials, the Company and surgeons reviewed the data from various patients and discussed next steps and strategies for the existing trials and designs for future phase II and III studies.
“Using high resolution imaging technology, we have been observing evidence indicating that the transplanted RPE cells are getting to the right place in the sub-retinal space, engrafting and are apparently resurfacing areas of the retina with a new RPE layer,” said Robert Lanza, M.D., ACT's chief scientific officer. “With multiple follow-ups happening across multiple trial sites with these patients, we also continue to see an encouraging trend with respect to subjective and objective observations relating to visual acuity, color perceptions and contrast in vision. In the case of the first dry AMD and SMD patients, the visual acuity gains we saw more than a year ago continue to persist.”
The RPE layer plays a central role in the health and function of the photoreceptor layer. In treating various forms of macular degeneration, such as dry AMD and SMD, the goal of the company's RPE cell therapy is for repair and replacement of those areas in the eye where the RPE layer has degraded with new cells, and in doing so, recapitulate the correct working environment around the photoreceptor layer.
Gary Rabin, chairman and CEO, in reference to the conference call scheduled for 4:30 p.m. EST today, said, “We are extremely pleased with these results, and plan to visually share a few examples today. While we remain cautious as the data is still very preliminary, the enthusiasm it has created within our clinical group makes me believe that we are ready to focus on earlier stage dry AMD and SMD patients where we hope we to show that our RPE therapy may be a meaningful treatment for these debilitating, sight-threatening diseases, while addressing a large unmet medical need.”
With respect to the conference call, interested parties may dial (888) 264-3177 or (706)902-4345 using reference conference ID number 90962762. The call will be available live and for replay by webcast at: http://us.meeting-stream.com/advancedcelltechnology110812.
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: November 2012