ACT announces results from three ongoing stem cell clinical trials for macular degeneration

Nov 9 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."