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Executive Summary

CytoTherapeutics' polymer-encapsulated cell implants will be regulated by the Center for Biologics Evaluation & Review as biologicals, with the Center for Drugs contributing to the medical review, company scientist Lisa Christenson, PhD, told a BioEast '92 meeting in Washington, D.C. Jan. 14. "Until very recently it was a little confusing as to which center at FDA we should approach for approval," Christenson said. CytoTherapeutics' products -- immuno-isolated cells which secrete useful agents such as insulin -- could be considered devices, drugs, or biologicals, she said. With the Nov. 21 publication of FDA intercenter agreements, however, the situation clarified, Christenson said. The agreements stipulate that CBER is responsible for "products composed of or intended to contain intact cells" and that CDER would assist CBER in reviewing "medical products intended for diagnostic or therapeutic use in hormonal disorders, neurological or psychiatric disorders, surgery indications or analgesia" ("The Pink Sheet" Nov. 25, p. 14). CytoTherapeutics has being predicting the filing of its first IND by the end of the year. The company's lead project is the NeuroCRIB implant of dopamine secreting cells for treatment of Parkinson's disease ("The Pink Sheet" Feb. 11, T&G-5). The company forecasts an IND filing for its EndoCRIB insulin secreting cell line for treatment of diabetes in 1993. Christenson told the BioEast meeting that the firm is also developing a neuro- growth factor secreting implant for Alzheimer's and an implant for treatment of chronic pain. "We're a little more comfortable now that we know who to approach," Christenson observed, "but there are still some concerns as there are with any new therapy going into the FDA. We need to maintain a clear pathway of communication." CytoTherapeutics, formerly know as Cellular Transplants, Inc., is a privately-held company based in Providence, R.I. The company recently completed a $15.4 mil. private placement, with investors including Genentech. Proceeds will be used to continue preclinical research on NeuroCRIB and EndoCRIB, fund operation of the company's pilot manufacturing plant, and to expand research.

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