CYTOTHERAPEUTICS TO FILE 1st IND IN SUMMER?

5 June 1994

Implantable delivery systems specialist CytoTherapeutics is on target to file its first Investigational New Drug application in the summer, according to chairman and chief executive of the company Seth Rudnick. The company is in the enviable position of having a delivery system to the brain which can be broadly applied across a range of biologically-active cell and gene therapy products.

The technology which CytoTherapeutics has developed is elegantly simple; cell-containing devices that are designed to treat central nervous system disorders by restoring lost cell functions are implanted into the brain or spinal cord, bypassing the blood-brain barrier and providing therapeutic agents for several months or more. After identifying and developing via genetic engineering a cell line appropriate to treat a disease, the cells are encapsulated within a semi-permeable membrane, which shields the cells from the immune system and allows the passage of both therapeutic substances and nutrients.

This site-specific delivery can be achieved without the need for immunosuppressive agents, and in time it is hoped that the implantation procedure will be simple enough to be carried out on an out-patient basis. The program on which the company was based, using an implant called EndoCRIB to deliver insulin for treating diabetes, has now been transferred to Neurocrin in exchange for an equity stake in the company as it does not fit with CytoTherapeutics' primary CNS focus.

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