|Shares of ACTC nearly double after only one week|
|By Staff and Wire Reports|
|Tuesday, 30 November 2010 13:21|
We continue to watch Advanced Cell Technology (ACTC.OB) after seeing shares jump 15% yesterday and another 21% today. This morning, the company announced that it has filed an Investigational New Drug (IND) Application with the US Food and Drug Administration (FDA) to initiate a Phase I/II multicenter study using human embryonic stem cell (hESC) derived retinal pigment epithelial (RPE) cells to treat patients with Dry Age-Related Macular Degeneration (Dry AMD)- which reportedly afflicts more than 30 million people worldwide, including nearly 15 million Americans.
Shares of the California-based micro-cap whose stock was trading for about a nickel last week traded as high as eleven and a half cents this morning and could continue to see share price appreciation.
Last week, Advanced Cell Technology received the green light from US regulatory authorities to commence a study measuring the effectiveness of the company’s embryonic stem cell-based retinal pigment epithelium (RPE) program, which is intended to restore vision for those suffering from severe vision loss.
That trial is due to commence early in 2011 as ACTC looks to treat Stargardt’s Disease, a form of juvenile macular degeneration.
Dry AMD, or “central geographic atrophy,” is the “dry” form of advanced Age-Related Macular Degeneration. Dry AMD occurs when the light-sensitive cells (photoreceptors) in the macula slowly break down, gradually blurring central vision in the affected eye. Over time, as less of the macula functions, central vision is gradually lost in the affected eye, often progressing to blindness. The loss of photoreceptors is a direct result of a preceding degeneration of the RPE layer of cells just below the retina. Dry AMD is much more common than wet AMD, which results from aberrant blood vessel formation in the eye. Some 85-90 percent of all people with intermediate and advanced AMD combined suffer from the dry form. Despite representing a $25-30 Billion market opportunity, there are currently no FDA-approved treatments for Dry AMD available.
“We can generate a virtually unlimited supply of healthy RPE cells,” said Robert Lanza, MD, ACT’s Chief Scientific Officer. “In our animal studies, we observed significant improvement in visual performance over untreated animals, and did not find any adverse effects of the injection of RPE cells. In extending our studies to human patients, it is our hope that we will show that the injected RPE cells will rescue photoreceptors and slow, if not stop, the progression of macular degeneration.”
Company scientists view the use of the same hESC derived RPE cells for both trials as the most efficacious approach, as it permits the Company to leverage its experience with the FDA that it gained through the process of obtaining approval for the Stargardt’s clinical trial to expedite the approval of its clinical trial in Dry AMD.
“We are seeing the beginning of new era in medical treatment,” continued Dr. Lanza. “The hope that stem cell therapies may one day repair and regenerate diseased organs and tissue goes far beyond what can be accomplished with traditional medicine. This approval shows an apparent readiness by the FDA to work with researchers to move exciting new stem cell based therapies out of the lab and into the clinic.”
“Filing this IND represents the culmination of years of innovation and hard work by ACT’s scientific team,” said William M. Caldwell IV, Chairman and CEO of ACT. “With this second IND, and our plans to expand our studies in Europe, ACT is positioning itself as a true ‘translational’ leader in the field of regenerative medicine. When you are the first, the whole world's eyes are on you, and in our case, most especially the eyes of the patients that suffer from AMD. We do not intend to let them down. We welcome this challenge, and of course plan to scale up our operations, as necessary, to continue to meet our milestones and help validate this technology platform.”