Feb 14, 2013 (Close-Up Media via COMTEX) -- Advanced Cell Technology, Inc.'s
clinical partner, the University of California, Los Angeles, has received
approval of its Investigator Investigational New Drug Application with the US
Food and Drug Administration.
In a release, the Company noted it was led by Steven Schwartz, Ahmanson
Professor of Ophthalmology at the David Geffen School of Medicine at UCLA and
retina division chief at UCLA's Jules Stein Eye Institute, to initiate a Phase
I/II study using ACT's retinal pigment epithelial cells derived from human
embryonic stem cells to treat myopic macular degeneration, commonly known as
nearsightedness. The primary focus of the study will be to evaluate the safety
in patients with severe myopia of the type that causes fissures in the RPE layer
of the eye.
Schwartz is the principal investigator in each of ACT's two Phase I/II clinical
trials for Stargardt's macular dystrophy and dry age-related macular
degeneration (dry AMD) using RPE cells derived from hESCs. The approval was
announced by Schwartz in his presentation at Bascom Palmer Eye Institute's tenth
annual angiogenesis meeting, "Angiogenesis, Exudation, and Degeneration 2013,"
"We are encouraged by Dr. Schwartz's keen interest in the evaluation of ACT's
RPE cells in potentially treating myopia," said Gary Rabin, chairman and CEO of
ACT. "We are pleased to be on track to broaden the scope of our RPE program with
the initiation of the new Investigator IND. Nearsightedness is a very common
condition, worldwide, and it is estimated that roughly 30 percent of cases are
high, or severe, myopia."
The myopia clinical trial will follow a similar protocol as the company's three
other human clinical trials in the U.S. and Europe using hESC-derived RPE cells
to treat forms of macular degeneration. The trial will enroll a total of 12
patients, with cohorts of three patients in an ascending dosage format. The
trial is a prospective, open-label study designed to determine the safety and
tolerability of hESC-derived RPE cells following sub-retinal transplantation
into patients with myopia at 12 months, the study's primary endpoint.
Preliminary results from the U.S. Stargardt's and Dry Age Related Macular
Degeneration trials were reported in The Lancet earlier this year.
"We look forward to initiating the clinical trial," said Schwartz. "Myopic
degeneration is an increasingly important global cause of permanent central
vision loss for which there is no accepted treatment. Applying our key learnings
from the ongoing ACT-sponsored stem cell trials allows the research promise of
regenerative medicine to include myopic vision loss."
Robert Lanza, ACT's chief scientific officer, said, "Myopia is one of the most
common medical ailments in the world and myopic patients have a higher risk of
permanent vision loss due to complications such as fissures in the RPE layer of
the eye. We are anticipating Dr. Schwartz's evaluations, potentially leading to
a treatment for those patients at high risk of vision loss from this condition."
Advanced Cell Technology, Inc. is a biotechnology company applying cellular
technology in the field of regenerative medicine.
The Jules Stein Eye Institute at UCLA is dedicated to the preservation of vision
and the prevention of blindness.