Published on January 9, 2010 at 1:28 AM
Advanced Cell Technology, Inc. (OTCBB:ACTC),
a biotechnology company applying cellular technology in the field of
regenerative medicine, announced today that it has received notification
from the US Food and Drug Administration (FDA) that the Agency is
currently drafting a response to the Company relating to the
Investigational New Drug (IND) Application it filed in November seeking
clearance to initiate a Phase I/II multicenter study using embryonic
stem cell derived retinal cells to treat patients with Stargardt’s
Macular Dystrophy (SMD). ACT is currently on clinical hold pending a
response from the Agency, which it expects within the next few weeks.
“We look forward to receiving the FDA's response and working with them
to address any questions that they may have”
“We look forward to receiving the FDA's response and working with them
to address any questions that they may have,” said William M. Caldwell
IV, Advanced Cell’s Chairman and CEO. “Although ACT has taken important
steps to advance our RPE program during the last several years, we
anticipate the need for further discussions with the Agency before
clinical trials can proceed.”
SOURCE Advanced Cell Technology, Inc.