Advanced Cell Technology, Inc., an emerging biotechnology company that specializes in the development of cellular therapies for the treatment of rare and common diseases that impact millions of people worldwide, recently announced an update regarding its clinical trials utilizing embryonic stem cells to treat eye disease. Advanced Cell Technology has received notification from the U.S. Food and Drug Administration (FDA) that the agency is currently drafting a response regarding its Investigational New Drug application it filed in November 2009.
The FDA has given clearance to initiate a Phase I / Phase II multicenter study using embryonic stem cell derived retinal cells to treat patients with Stargardt’s Macular Dystrophy (SMD). Advanced Cell Technology expects a response from the FDA within the next few weeks.
William M. Caldwell IV, Advanced Cell Technology’s chairman and chief executive officer, stated, “We look forward to receiving the FDA’s response and working with them to address any questions that they may have.” Mr. Caldwell continued, “Although Advanced Cell Technology has taken important steps to advance our Retinal Pigment Epithelial program during the last several years, we anticipate the need for further discussions with the agency before clinical trials can proceed.”