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., Jan 08, 2013 (BUSINESS WIRE) -- 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
advancedcell.com. |
