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NEI Awards Cellular Dynamics $1.2M Contract for iPSCs for Development of AMD Drug

NEW YORK (GenomeWeb) – Cellular Dynamics International today announced a $1.2 million contract from the National Eye Institute to manufacture stem cells for use in the development of a new potential treatment for dry age-related macular degeneration.

The Madison, Wis.-based firm will manufacture clinically compatible induced pluripotent stem cells and iPSC-derived human retinal pigment epithelial cells from individuals with AMD for use in investigational new drug-enabling studies. If the IND is approved, the same procedures will be used to generate clinical grade iPSC-derived retinal pigment epithelial cells for transplantation into AMD patients. Cellular Dynamics said the process, called autologous cellular therapy, would be the first of its kind in the US.

The company will reprogram skin and blood samples from AMD patients to create iPSCs that are genetically identical to the patient, reducing the risk of transplant rejection. It will use existing NEI differentiating protocols to develop and optimize methods for manufacturing retinal pigment epithelial cells and provide the institute with cGMP-ready protocols and training for their manufacture.

Researchers at NEI will use the cells as part of their pre-clinical process to develop the first autologous cell transplantation treatment for dry AMD.

Cellular Dynamics noted that AMD is the leading cause of vision-loss in people 60 years of age and older. Citing statistics from the Bright Focus Foundation, the company said that as many as 11 million Americans have some form of macular degeneration. There are no therapies for dry AMD that are approved by the US Food and Drug Administration, while therapies for wet AMD "require repeated eye injections that slow, or, at best, arrest disease progression," the firm said in a statement, adding that wet AMD products generated revenues of more than $5.75 billion in 2013.

NEI Scientific Director Sheldon Miller said in a statement, "This is a first step toward our phase I IND enabling studies. There are a small number of facilities in the US with the capacity to generate iPSCs and differentiate them into multiple lineages."