News & Analysis

Advanced Cell Tech (OTCBB: ACTC) -7% Despite European Annoncement

Advanced Cell Technology, Inc. (OTCBB: ACTC): is trading down 7 percent at $0.20 mid-day today despite an announcement today that, working with the European regulatory consulting firm TMC Pharma Services, it has filed for Orphan Drug Designation with the European Medicines Agency (EMA) for its Retinal Pigment Epithelial (RPE) Cells for use in treatment of Stargardt’s Macular Dystrophy (SMD), also known as Stargardt’s Disease.  The symbol has consistent risen with a 52-week range between $0.06-$0.20
 
Orphan drug designation may provide the company with several advantages, including ten years of marketing exclusivity for embryonic stem cell derived RPE cells upon market authorization for the indication, financial incentives such as fee reductions or waivers, provide free scientific advice during the drug development process, and access to a centralized review process for all 27 member states.

“In the past month, we announced significant milestones in our macular degeneration program,” said Gary Rabin, ACT’s Interim Chairman and CEO. “We have been approved to begin our first clinical trial in the United States for the treatment of SMD using stem-cell derived RPE cells. We have also filed an investigational new drug application with the FDA for treating dry age-related macular degeneration, or Dry AMD, which represents a $25-30 billion market in the US and Europe alone, with no treatments currently available. Earlier this year, we received orphan drug designation from the U.S. FDA for our SMD program, which grants the Company seven years of marketing exclusivity in the U.S., among other benefits. Building on this momentum, ACT has now taken the next important step in expanding our global efforts by filing for Orphan drug status in Europe, identifying clinical trial sites and establishing our European operations.”

Also today, Dr. Robert Lanza, the Chief Scientific Officer of Advanced Cell Technology was featured and interviewed as "one of the leading scientists making breakthroughs in his field" on Explorations in Science with best-selling author and television personality, Dr. Michio Kaku. 

For only the second time in history, the Food and Drug Administration approved the human trial of a therapy developed from embryonic stem cells when Lanza and the team at Advanced Cell Technology secured approval for human trials of their retinal pigment epithelial cells to treat Stargardt's Macular Dystrophy.

Advanced Cell Technology, Inc., a biotechnology company, focuses on the development and commercialization of human embryonic and adult stem cell technology in the field of regenerative medicine. It primarily focuses on cellular reprogramming, reduced complexity program, and stem cell differentiation research programs. The company?’s cellular reprogramming involves in the development of therapies based on the use of genetically identical pluripotent stem cells generated by its cellular reprogramming technologies. Advanced Cell Technology, Inc. is also generating stable cell lines with particular focus on blood lineage and vascular epithelial cell lines from hemangioblast cells. In addition, it is developing an autologous myoblast transplantation therapy to restore cardiac function in patients with advanced heart disease. The company?’s stem cell-based therapy would provide treatment for a range of acute and chronic degenerative diseases. Further, it develops adult stem cell-based products that are specifically targeted at therapies for heart and other cardiovascular diseases. The company is headquartered in Worcester, Massachusetts.